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  • 1Recruiting
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• applications(array)
  • 0(array)
    • Application(array)
      • id949
      • user_id655
      • trial_status_id(null)
      • abstract_of_study<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Typhoid fever is an enteric bacterial infection caused by <em>Salmonella enterica</em> serovar Typhi (Salmonella Typhi; S. Typhi). It is an important infectious disease in low- and middle-income countries with over 10.9 million new cases worldwide and 116.8 thousand death in 2017. South Asia and Sub Saharan Africa are the most affected areas of the world. Typhoid fever is common in areas with inadequate sanitation and hyegine. In routine practice, diagnosis of typhoid fever is rarely confirmed as diagnostic tests are unavailable or have limited diagnostic accuracy. Blood culture is the commonest reference standard test but has a lower sensitivity. Bone marrow culture is more sensitive than blood culture yet is rarely used because it requires invasive sampling, adequate infrastructure and skilled staff and mainly used for research purposes. Alternatives to those methods exist but their performance is poor. The Widal test is still used but as it is based on cross-reactive antigens, it lacks sensitivity and specificity. Clinician often use rapid diagnostic tests to diagnose typhoid. A number of typhoid fever RDTs are commercially available but performance data are not available or not consistent from a study to another. Therefore, this study will aim to perform a head to head comparison of typhoid tests currently in the market to help inform Ministry of Health in Kenya and the WHO Essential Diagnostic list (EDL) and stakeholder decision making more broadly.</span></span></p>\n
      • study_title<p align=\"center\">\n <strong>Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools</strong></p>\n
      • laymans_summary<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Typhoid fever bacterial disease caused by <em>Salmonella</em> Typhi. It is one of the most common serious bacterial diseases in the developing world, with an estimated 10.9 million people contracting the disease worldwide and 116.8 thousand people dying of the disease in 2017. Culture method using blood and bone marrow samples are considered as the benchmark for teting for typhoid disease. Those methods are however time consuming, requires drawing blood from the body, and requires adequate infrastructure and trained staff that are not available in most of areas where the disease is very common locally. There are other methods but their performance is poor. The Widal test is a cheap test that is widely used despite its high rate of giving test results which wrongly indicates that typhoid is present. Rapid Diagnostic tests (RDTs) have been developed and are available in the market but their performance data are not available or not consistent from one study to another. Therefore, this study will aim to perform a direct comparison of typhoid tests currently in the market to help inform the Ministry of Health in Kenya and the WHO Essential Diagnostic list (EDL) and stakeholder decision making more broadly.</span></span></p>\n
      • short_titleCommercial Typhoid tests valid
      • protocol_noECCT/20/10/03
      • version_no2.0
      • date_of_protocol11-08-2020
      • study_drugN/A- Evaluation of 11 Rapid Diagnostic Kits (RDTs)
      • disease_conditionTyphoid Fever
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_name11 Typhoid Rapid Diagnostic Kits (RDTs)
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrobert.s.onsare@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
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      • applicant_participating_countries(null)
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      • applicant_stability_data1
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      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Robert S. Onsare
      • declaration_date122-10-2020
      • declaration_principal_investigatorElizabeth W. Ndegwa
      • declaration_date222-10-2020
      • placebo_presentNo
      • study_objectives<p style=\"margin-left:21.6pt;\">\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><strong>General Objective</strong></span></span></p>\n<p style=\"margin-left:21.6pt;\">\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">To compare commercially available typhoid point of care tests to benchmark the golden standard method of blood culture a currently emerging method of PCR.</span></span></p>\n<p style=\"margin-left:21.6pt;\">\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><strong>Primary Objective</strong></span></span></p>\n<ol>\n <li value=\"1.1\">\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">To evaluate different RDTs that are commercially available internationally for detecting antigens or antibodies to <em>Salmonella</em> Typhi and use Blood culture as standard for comparison.</span></span></li>\n</ol>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><strong>Secondary Objectives</strong></span></span></p>\n<ol>\n <li value=\"2.1\">\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Establish a biorepository of well characterized specimen collection that can be used to evaluate emerging tests.</span></span></li>\n <li value=\"2.2\">\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Evaluation of operational characteristics (invalid and indeterminate rates) of Typhoid RDTs</span></span></li>\n</ol>\n
      • principal_inclusion_criteria<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Participants are eligible to be included in the Trial only if all of the following inclusion criteria apply:</span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Individuals aged 8 years of age to 65 years of age</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">History of fever or axillary temperature of >37.5⁰Cfor at least 3 consecutive days within the last 7 days prior to enrolment</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Clinical suspicion of enteric fever</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">One of the following scenarios:</span></span></li>\n</ul>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Presents to outpatient department or Emergency Department</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Admitted to hospital within last 12 hours</span></span></li>\n</ul>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Able and willing to provide informed consent (and assent when required)</span></span></li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Participants are excluded from the Trial if any of the following exclusion criteria apply:</span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Unwillingness to participate in the study</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Inability to provide the required volume of blood</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Unwillingness to provide blood</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Known non-infectious / Non typhoid Infectious causes of fever or other alternate diagnosis of fever</span></span></li>\n</ul>\n
      • primary_end_points<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Point estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference standard.</span></span></p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyThis is a prospective multicentre Typhoid diagnostic accuracy study evaluating 11 commercially available Rapid Diagnostic Kits using collected blood and/or serum samples that will be conducted in three hospitals at Nairobi, Kenya.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">The trial study will take place in three health facilities in Nairobi County, namely: Mbagathi County Hospital, Mbagathi Road; Medical Missionaries of Mary, Reuben Centre Hospital in Mukuru Slum, Embakasi and City Council Clinic in Mukuru Slum, Embakasi. Brief profiles of each of these health facilities is provided below:</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><strong>1. Mbagathi County Hospital</strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Mbagathi Hospital is a District (County) Hospital within Nairobi County with the largest catchment area of about one million people, comprising mainly of the underprivileged (<a href=\"http://mbagathihospital.or.ke/about/\">http://mbagathihospital.or.ke/about/</a>). The main hospital facility is located in Kenyatta/Golf Course, Dagoretti Division of Nairobi West District. It borders the Kenyatta National Hospital, Kenyatta City Council Market, Forces Memorial Hospital, the Kenya medical Research Institute and the Kibera slums. It is the only public health facility within Nairobi that the Ministry of Health relies on to decongest the Kenyatta National Hospital which is mandated to handle referral cases. It is also an <strong>Approved Internship</strong><strong> Training </strong><strong>Center</strong> certified by the Kenya Medical Practitioners and Dentists Council.  Mbagathi County Hospital offers the following services: Casualty/A&E, In-patient, dental clinic, radiology and a large laboratory with the following units: Hematology, Microbiology and Parasitology, Histology and Cytology, Clinical chemistry, Special Chemistry. Among other services. It therefore has capacity to receive patients and laboratory facilities to collect blood samples from the patients. The collected blood samples will be transported to the Centre for Microbiology Research (CMR), Kenya Medical Research Institute (KEMRI) laboratories where all the testing of the RDTs will take place.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\"><strong>2. Reuben Centre Hospital, Mukuru</strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">Reuben Centre Hospital is located in Mukuru kwa Njenga, an informal settlement in Nairobi. It is located within the Reuben Centre (<a href=\"https://www.rubencentre.org/\">https://www.rubencentre.org/</a>) that traces its earlier support from the Catholic church’s Medical Missionaries of Mary (<a href=\"https://mmmworldwide.org/index.php/our-work/countries/kenya\">https://mmmworldwide.org/index.php/our-work/countries/kenya</a>). The County government of Nairobi has also since embarked on significantly financially supporting the hospital. It provides basic health care in a huge slum area with well over 600,000 people.  Many live there because it is near the industries. The health centre offers both inpatient maternal and child health services; nutrition education and support for malnourished children; cervical cancer screening; HIV/AIDS and TB services; home-based care; assistance for children living with disabilities; and a school health programme as well as outpatient services. Community health volunteers help with TB screening and awareness-raising about gender-based violence and human trafficking. The health facility has well equipped laboratory that serves the patients that visit it on a daily basis. It therefore has capacity to receive patients and laboratory facilities to collect blood samples from the patients. The collected blood samples will be transported to the Centre for Microbiology Research (CMR), Kenya Medical Research Institute (KEMRI) laboratories where all the testing of the RDTs will take place.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">3. <strong>City Council Clinic, Mukuru</strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:times new roman,times,serif;\">City Council Clinic is located in Mukuru informal settlement in Nairobi. It operates outpatient health facilities and offers basic health services including adult and child consultations and treatments as well as basic laboratory services. Ithas capacity to collect blood samples from the patients. The collected blood samples will be transported to the Centre for Microbiology Research (CMR), Kenya Medical Research Institute (KEMRI) laboratories where all the testing of the RDTs will take place.</span></span></p>\n
      • other_details_explanation<p>\n Not applicable. Trial is being conducted in Kenya, the host Country of the applicant</p>\n
      • other_details_regulatory_notapproved<h4 class=\"text-white\">\n NATIONAL COMMISSION FOR SCIENCE,TECHNOLOGY & INNOVATION (NACOSTI), DATE OF APPLICATION: SEPTEMBER 30, 2020</h4>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) Scientific & Ethics Review Unit (SERU): Date of approval September 2, 2020, Approval No. KEMRI/SERU/ 4076</p>\n
      • other_details_regulatory_rejected<p>\n N/A: NONE HAS REJECTED</p>\n
      • other_details_regulatory_halted<p>\n N/A; Trial has not been halted</p>\n
      • estimated_duration6 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteMbagathi County Hospital - 840, Medical Missionaries of Mary, Reuben Centre Hospital Mukuru - 840, City Council Clinic in Mukuru Slum - 840
      • total_participants_worldwide2520
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameWairima
      • investigator1_family_nameNdegwa
      • investigator1_qualificationRegistered Clinical Officer
      • investigator1_professional_addressCentre for Respiratory Diseases Research (CRDR), Kenya Medical Research Institute (KEMRI), Nairobi
      • investigator1_telephone+254722938831
      • investigator1_emailendegwa@gmail.com
      • organisations_transferred_No
      • number_participants2520
      • notification<p>\n None</p>\n
      • approval_date28-12-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-10-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-12-28 09:38:32
      • created2020-10-19 11:42:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id597
        • application_id949
        • given_nameRobert
        • middle_nameSanaya
        • family_nameOnsare
        • qualificationPh.D (Medical Microbiology), M.Sc (Medical Microbiology), B.Sc (Hons)
        • professional_addressCentre for Microbiology Research (CMR), Kenya Medical Research Institute (KEMRI), Nairobi
        • telephone+254722337004
        • emailrobert.s.onsare@gmail.com
        • created2020-10-19 11:58:37
        • modified2020-10-22 02:11:17
    • SiteDetail(array)
      • 0(array)
        • id825
        • application_id949
        • county_id47
        • site_nameMbagathi County Hospital
        • physical_addressMbagathi Road, Nairobi
        • contact_detailsHospital Superitendent
        • contact_personHospital Superitendent
        • site_capacity(null)
        • misc(null)
        • created2020-10-19 11:58:37
        • modified2020-10-22 02:11:17
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id829
        • application_id949
        • county_id47
        • site_nameMedical Missionaries of Mary, Reuben Centre Hospital, Mukuru
        • physical_addressReuben Centre, Mukuru Slum, Nairobi
        • contact_detailsHealth Centre in-charge
        • contact_personHealth Centre in-charge
        • site_capacity(null)
        • misc(null)
        • created2020-10-21 23:42:37
        • modified2020-10-22 02:11:17
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id830
        • application_id949
        • county_id47
        • site_nameCity Council Clinic, Mukuru
        • physical_addressMukuru Slum, Embakasi, Nairobi
        • contact_detailsHealth Centre in-charge
        • contact_personHealth Centre in-charge
        • site_capacity(null)
        • misc(null)
        • created2020-10-21 23:43:52
        • modified2020-10-22 02:11:17
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id461
        • application_id949
        • sponsorFoundation for Innovative New Diagnostics (FIND)
        • sponsor_typeOthers
        • contact_personSabine Dittrich
        • addressCampus Biotech, Chemin des Mines 9, 1202 Geneva, Switzerland
        • telephone_number+41(0)227100590
        • fax_number
        • cell_number+41 (0) 79 431 62 44
        • email_addressSabine.Dittrich@finddx.org
        • created2020-10-19 11:58:37
        • modified2020-10-22 02:11:17
  • 1(array)
    • Application(array)
      • id928
      • user_id32
      • trial_status_id8
      • abstract_of_study<div>\n It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. We will conduct an observational cohort study in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42 and blood samples at 3, 6, and 12 months. Patients self-isolating will be phoned daily for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. Participants will potentially benefit from close observations. Society may benefit from improved understanding of the impact of COVID-19 in malaria-endemic areas. The study is anticipated to start in October 2020 and last for approximately 18 months.</div>\n
      • study_title<div>\n Malaria as a risk factor for COVID-19 in western Kenya and Burkina Faso (MALCOV)</div>\n
      • laymans_summary<div>\n We will conduct a clinical study in western Kenya and Burkina-Faso to determine if malaria affects the severity of COVID-19 or its duration. Some patients with COVID-19 also have malaria. We will determine if the treatment of malaria with pyronaridine-artesunate in these patients has an effect on COVID-19 severity or the immune response to COVID-19. Pyronaridine-artesunate is a highly effective malarial treatment that is being rolled out in Africa. In laboratory tests, pyronaridine-artesunate is able to kill viruses, including SARS-CoV-2, the Coronavirus that causes COVID-19. We will follow 708 patients of all ages with COVID-19 for 12 months (the ‘COVID-19 cohort study’). They will be enrolled from a population of approximately 4,720 patients who are being screened for COVID-19 (‘Screening study’). It is anticipated that about 1 in 5 of the 708 COVID-19 patients will also have malaria (about 142). They will be treated with either artemether-lumefantrine (the current standard malaria treatment) or artemether-lumefantrine. The assignment will be decided by chance (random). Hospitalisation, selfisolation and home-based care will follow national guidelines. All 708 COVID-19 patients will be seen again during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42 when swabs for COVID-19 tests and blood samples will be taken. They will then be seen again at 3, 6, and 12 months. The severity and duration of symptoms, the immune response, and the time that patients remain infectious (can spread the virus to others) will be compared between COVID-19 patients with malaria and without malaria, and between patients treated with artemether-lumefantrine and with pyronaridine-artesunate. Strict adherence to personal protection equipment (PPE) will be used to limit the transmission of the Coronavirus. The transport arrangements for patients and staff will follow national COVID-19 guidelines. Written informed consent/assent will be sought. Participants will potentially benefit from close observations. There is a potential benefit to society as the study will help to obtain a better understanding of the impact of COVID-19 on people’s health in malaria-endemic areas. The study is anticipated to start in October 2020 and finish approximately 18 months later in March 2022.</div>\n
      • short_titleMALCOV
      • protocol_noECCT/20/10/02
      • version_nov1.2
      • date_of_protocol12-10-2020
      • study_drugPyronaridine-artesunate vs Artemether-lumefantrine
      • disease_conditionMalaria, COVID-19
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether-lumefantrine vs Pyronaridine-artesunate
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstonysangke@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Tony Sang
      • declaration_date129-10-2020
      • declaration_principal_investigatorDr Simon Kariuki (Principal Investigator)
      • declaration_date229-10-2020
      • placebo_presentNo
      • study_objectives<div>\n <u>Screening study (cross-sectional survey source population)</u></div>\n<ul>\n <li>\n To determine if malaria infection is predictive of the prevalence of SARS-CoV-2, adjusted for other risk factors of SARS-CoV-2 infection</li>\n</ul>\n<div>\n  </div>\n<div>\n <u>COVID-19 cohort study</u></div>\n<ul>\n <li>\n To determine if malaria infection affects COVID-19 severity</li>\n</ul>\n<div>\n  </div>\n<div>\n <u>Nested malaria treatment trial</u></div>\n<ul>\n <li>\n To determine if pyronaridine-artesunate compared to artemetherlumefantrine reduces early SARS-CoV-2 viral shedding</li>\n</ul>\n
      • principal_inclusion_criteria<div>\n <strong>Screening study (cross-sectional survey source population)</strong></div>\n<ul>\n <li>\n Patients attending COVID-19 test centres or other clinics conducting testing for COVID-19</li>\n <li>\n Patient population admitted to the COVID-19 isolation facilities</li>\n <li>\n Contacts of confirmed or suspected cases as part of contact tracing</li>\n <li>\n Populations as part of targeted testing of high-risk populations (e.g., frontline health care workers)</li>\n</ul>\n<div>\n  </div>\n<div>\n <strong>COVID-19 cohort study</strong></div>\n<ul>\n <li>\n Laboratory confirmed SARS-CoV-2 infection, with positive molecular test results within the past 72 hours*</li>\n <li>\n Aged >=6 months **</li>\n <li>\n Resident in the study area</li>\n <li>\n The participant or caretaker is willing and able to give informed consent or assent with parent/guardian informed consent for participation in the study</li>\n <li>\n Agrees not to self-medicate with chloroquine, hydroxychloroquine or other antimalarials with potential anti-SARS-CoV-2 properties</li>\n <li>\n Not previously diagnosed with COVID-19</li>\n <li>\n Contactable by phone for follow-up</li>\n</ul>\n<div>\n <div style=\"margin-left: 40px;\">\n * We anticipate that most tests results will be available within 24 hours. The maximum of 72 hours is a target and can be increased in sites that experience significant delays related to routine testing for SARS-CoV-2 by the local health authorities.</div>\n <div style=\"margin-left: 40px;\">\n ** Children < 6 months will be excluded because of the inconvenience of repeated blood sampling and because they have a different clinical presentation of malaria than older children, as they are partially protected from developing clinical malaria due to the protective effect of maternal immunity after birth and through factors that inhibit parasite growth, such haemoglobin F (HbF).</div>\n <div>\n  </div>\n <div>\n <strong>Nested malaria treatment trial</strong></div>\n <ul>\n <li>\n Fulfils all inclusion criteria for the COVID-19 cohort study</li>\n <li>\n Uncomplicated malaria, defined as able to take oral medication</li>\n <li>\n Bodyweight ≥5kg</li>\n <li>\n Confirmed malaria infection by RDT or microscopy</li>\n </ul>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n <strong>Screening study (cross-sectional survey source population)</strong></div>\n<ul>\n <li>\n Unwilling or unable to provide informed consent/assent</li>\n</ul>\n<div>\n  </div>\n<div>\n <strong>COVID-19 cohort study</strong></div>\n<ul>\n <li>\n Unwilling or unable to provide informed consent/assent</li>\n <li>\n The participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results</li>\n <li>\n Pregnant or lactating women</li>\n <li>\n Inability/unlikely to be in the study area for the duration of the 28-day follow-up period</li>\n</ul>\n<div>\n  </div>\n<div>\n <strong>Nested malaria treatment trial</strong></div>\n<ul>\n <li>\n Fulfils any of the exclusion criteria for the COVID-19 cohort study</li>\n <li>\n Severe disease requiring parenteral treatment</li>\n <li>\n Currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine</li>\n <li>\n Received chloroquine in the last three days</li>\n <li>\n Inability/unlikely to be in the study area for the duration of the 42-day follow-up period</li>\n <li>\n Known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms</li>\n <li>\n Chronic kidney disease (Stage IV or receiving dialysis)</li>\n <li>\n Known liver cirrhosis (Child-Pugh Class B or greater) or signs or symptoms of severe hepatotoxicity</li>\n</ul>\n
      • primary_end_points<div>\n <strong>Screening study (cross-sectional survey source population)</strong></div>\n<ul>\n <li>\n Cross-sectional comparison of the proportion of participants with SARS-CoV-2 in the source population among participants with and without malaria infection expressed as the prevalence ratio for COVID-19 (95% CI)</li>\n</ul>\n<div>\n  </div>\n<div>\n <div>\n <strong>COVID-19 cohort study</strong></div>\n <div>\n <ul>\n <li>\n Comparison of the severity of COVID-19 by day-28 in cases with and without malaria using a severity index score</li>\n </ul>\n </div>\n <div>\n  </div>\n <div>\n <strong>Nested malaria treatment trial</strong></div>\n</div>\n<ul>\n <li>\n Incidence of SARS-CoV-2 clearance (defined as the proportion of participants with a negative nasal swab) on Day 7 after the start of treatment</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n The fieldwork will be conducted as part of the ongoing collaboration between KEMRI, CDC, and LSTM in the following hospitals in western Kenya which are located in areas with intense malaria transmission and local transmission of COVID-19: Kisumu County: Primary Hospital(s): Jaramogi Oginga Odinga Teaching and Referral Hospital (JOORTH), Kisumu County Referral Hospital. Secondary Expansion Hospitals: Lumumba Health Centre, Ahero County Hospital, KMET Cockran Clinic, St Elizabeth Mission Hospital, St Monica’s Mission Hospital; Busia County: Primary Hospital(s): Alupe sub-County Hospital, Secondary Expansion Hospitals: Busia County Teaching and Referral Hospital, Busia GK Prison Dispensary; Siaya County: Primary Hospital(s): Bondo sub-County Hospital, Secondary Expansion Hospitals: Siaya County Teaching And Referral Hospital, Ambira sub-County Hospital; Migori County: Macalder (Nyatike) sub-County Hospital, Migori County Teaching and Referral Hospital; Secondary Expansion Hospitals: Kehancha sub-County Hospital, Migori GK Prison Dispensary, Isebania sub-County Hospital. Other hospitals in the previous Nyanza and western Provinces may be considered if local outbreaks of Covid-19 start to occur in their catchment areas.</div>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration18 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-Lumefantrine
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites6 primary sites in 4 counties with an additional 12 possible secondary expansion hospitals
      • multi_country_listKenya\nBurkina Faso
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMinimum is 0, maximum is 142
      • total_participants_worldwide142
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyParental/ guardian\'s consent will be sought for all children below 18 years old. Additionally children aged 13 to 17 will be required to provide assent.\nFor illiterate participants, an independent witness will be present during the informed consent process and will sign the consent form as a witness, while the participant will be asked to indicate consent by use of thumbprint.\n
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_nameter
      • investigator1_family_nameKuile
      • investigator1_qualificationMd, PhD
      • investigator1_professional_addressLiverpool School of Tropical Medicine (LSTM), United Kingdom
      • investigator1_telephone+44 151 705 3287
      • investigator1_emailFeiko.terKuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants142\nEnrollment will be competitive until the desired sample size is achieved.
      • notification
      • approval_date23-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-11-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved by the expert committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-10-07 15:18:33
      • created2020-08-12 15:30:31
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id574
        • application_id928
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressKEMRI, Centre for Global Health Research,Kisumu , Kenya
        • telephone+254 725 389 246
        • emailskariuki@kemricdc.org
        • created2020-08-18 12:03:47
        • modified2020-11-23 17:05:34
      • 1(array)
        • id575
        • application_id928
        • given_nameHelen
        • middle_name
        • family_nameBarsosio
        • qualificationMD
        • professional_addressKEMRI, Centre for Global Health Research,Kisumu , Kenya
        • telephone+254 724 464 507
        • emailHellen.Barsosio@lstmed.ac.uk
        • created2020-08-18 13:12:27
        • modified2020-11-23 17:05:34
    • SiteDetail(array)
      • 0(array)
        • id803
        • application_id928
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital (JOORTH),
        • physical_addressKisumu
        • contact_detailsMobile: +254 724 464 507, E-mail: Hellen.Barsosio@lstmed.ac.uk
        • contact_personDr Hellen Barsosio
        • site_capacity(null)
        • misc(null)
        • created2020-08-18 12:03:47
        • modified2020-11-23 17:05:34
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id818
        • application_id928
        • county_id42
        • site_nameKisumu County Referral Hospital.
        • physical_addressKisumu Town
        • contact_detailsMobile: +254 724 464 507, E-mail: Hellen.Barsosio@lstmed.ac.uk
        • contact_personDr Hellen Barsosio
        • site_capacity(null)
        • misc(null)
        • created2020-10-06 13:00:41
        • modified2020-11-23 17:05:34
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id819
        • application_id928
        • county_id40
        • site_nameAlupe sub-County Hospital,
        • physical_addressBusia
        • contact_detailsMobile: +254 724 464 507, E-mail: Hellen.Barsosio@lstmed.ac.uk
        • contact_personDr Hellen Barsosio
        • site_capacity(null)
        • misc(null)
        • created2020-10-06 13:00:41
        • modified2020-11-23 17:05:34
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
      • 3(array)
        • id820
        • application_id928
        • county_id41
        • site_nameBondo sub-County Hospital,
        • physical_addressBondo Town
        • contact_detailsMobile: +254 724 464 507, E-mail: Hellen.Barsosio@lstmed.ac.uk
        • contact_personDr Hellen Barsosio
        • site_capacity(null)
        • misc(null)
        • created2020-10-06 13:00:41
        • modified2020-11-23 17:05:34
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 4(array)
        • id821
        • application_id928
        • county_id44
        • site_nameMacalder (Nyatike) sub-County Hospital
        • physical_addressMigori
        • contact_detailsMobile: +254 724 464 507, E-mail: Hellen.Barsosio@lstmed.ac.uk
        • contact_personDr Hellen Barsosio
        • site_capacity(null)
        • misc(null)
        • created2020-10-06 13:02:35
        • modified2020-11-23 17:05:34
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
      • 5(array)
        • id822
        • application_id928
        • county_id44
        • site_nameMigori County Teaching and Referral Hospital;
        • physical_addressMigori Town
        • contact_detailsMobile: +254 724 464 507, E-mail: Hellen.Barsosio@lstmed.ac.uk
        • contact_personDr Hellen Barsosio
        • site_capacity(null)
        • misc(null)
        • created2020-10-06 13:02:35
        • modified2020-11-23 17:05:34
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
    • Sponsor(array)
      • 0(array)
        • id448
        • application_id928
        • sponsorLiverpool School of Tropical Medicine (LSTM)
        • sponsor_typeResearch Institution
        • contact_person
        • addressPembroke Place, Liverpool L3 5QA, UK
        • telephone_number+44 0151 7053794
        • fax_number
        • cell_number+44 0151 7053794
        • email_addresslstmgov@lstmed.ac.uk
        • created2020-08-18 12:03:47
        • modified2020-11-23 17:05:34
  • 2(array)
    • Application(array)
      • id937
      • user_id81
      • trial_status_id7
      • abstract_of_study<div>\n Over 1.8 million people are infected with HIV globally every year. With long term treatment side effects and emerging drug resistance to available therapy, a safe and effective prophylactic HIV vaccine is key to halting the epidemic. We propose to evaluate the safety and immunogenicity among healthy adults in Kenya, Uganda and Zambia of three vaccines, called tHIVconsv1, tHIVconsv3; and tHIVconsv4. The vaccine regimen consists of a single mosaic prime ChAdOx1.tHIVconsv1 (C1, injected in both arms) and a dual boost of modified vaccinia virus Ankara (MVA) MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) each injected separately into separate arms at the same visit. This combination of HIV vaccines will be a first-in human trial. </div>\n<div>\n  </div>\n<div>\n The vaccines will be tested in parallel for safety in the United Kingdom, in a phase I trial. The safety and immunogenicity of a range of MVA and ChAdOx1-vectored vaccines has been demonstrated in numerous preclinical studies in mice and non-human primates, and in a number of clinical studies, in both healthy and HIV-1-infected volunteers. In this multicenter study, we will conduct a double-blind trial and randomize 88 HIV-uninfected healthy volunteers aged 18-50 years who are at low risk of HIV, to receive either a vaccine or a placebo at 2 vaccination visits 4 weeks apart. Enrolment will be over 16 weeks with each volunteer participating in the trial for approximately 52 weeks.</div>\n<div>\n  </div>\n
      • study_title<p>\n A Phase 1 Trial of ChAdOx1- and MVA-vectored Conserved Mosaic HIV-1 Vaccines in Healthy, Adult HIV-1-negative Volunteers in Eastern and Southern Africa. </p>\n
      • laymans_summary<div>\n <strong>Lay Title:</strong> A study to test three experimental HIV vaccines in healthy adults</div>\n<div>\n  </div>\n<div>\n <strong>What is the problem/background?</strong></div>\n<div>\n Approximately 36.9 million people are living with human immunodeficiency virus (HIV), the virus that causes AIDS, and it is estimated that over 1.8 million new infections occurred in 2017. Vaccination is the most effective way to prevent infection, but it has proved extremely difficult to develop an effective vaccine against HIV. At present, there is no licensed vaccine to prevent HIV infection available. One of the main reasons for this is the extraordinary ability of the virus to change itself so that the human immune system does not recognise it and the virus escapes detection. </div>\n<div>\n  </div>\n<div>\n To address differences in HIV, new types of vaccines have been developed at the University of Oxford, United Kingdom. Three vaccines, called tHIVconsv1, tHIVconsv3; and tHIVconsv4 contain artificial pieces similar to parts of HIV and will be tested in this study. The three vaccines are man-made and do not contain live HIV-1, therefore they cannot give people HIV-1 infection or AIDS. These vaccines are being tested for the first time in human beings.</div>\n<div>\n  </div>\n<div>\n <strong>What questions are we trying to answer?</strong></div>\n<div>\n The study aims to find out if the study vaccines are safe and how the body immune system responds to them.  In addition, the study aims to learn what kind of side effects will be experienced after receiving the study vaccines, and how severe those side effects will be. </div>\n<div>\n  </div>\n<div>\n Where is the study taking place, how many people does it involve and how are they selected?</div>\n<div>\n The study will be carried out at 4 research centers in Kenya, Uganda and Zambia involving a total of 88 healthy HIV-1-uninfected male and female adults aged 18-50 years. In Kenya, approximately 44 participants will be enrolled at KAVI-ICR in Nairobi, and the KEMRI-clinic in Mtwapa. In Mtwapa, approximately 22 participants will be enrolled from an HIV-1 vaccine feasibility cohort study.  In Mtwapa, participants who are > 30 years of age, and have been in follow up for more than two years, who in the opinion of the principal investigator or designee, understand the study and provide written informed consent, and are willing to use an effective method of contraception, will be invited for study screening.</div>\n<div>\n  </div>\n<div>\n A person will not participate in this study if he/she has a confirmed HIV infection; is pregnant or breastfeeding; has a serious or long-lasting disease; has abnormal laboratory test results; has recently received vaccination or blood products; has previously received an HIV vaccine; or has a history of severe local or systemic reactions to vaccination. </div>\n<div>\n  </div>\n<div>\n <strong>What does the study involve for those who are in it?</strong></div>\n<div>\n Blood, urine tests and body examinations will be done to check the general health and ensure they meet the requirements to participate in the research. If eligible and agree to participate, they will be assigned (like a flip of the coin) to receive 4 injections of the trial vaccine or 4 injections of a placebo – 2 injections at an initial visit (in one arm each) and another 2 injections (in one arm each), four weeks later. They will be asked to come to the clinic for follow up visits. A diary to record and report any signs or symptoms experienced after vaccination will be given.  A training on how to use the diary will be done. </div>\n<div>\n  </div>\n<div>\n <strong>What are the benefits and risks/costs of the study for those involved?  </strong></div>\n<div>\n There are no direct benefits of participating in the study. Volunteers will get information on their health and HIV status. With any vaccination, there is a possibility of temporary soreness around the injection site; redness, pain, swelling, itching, bruising, a warm feeling and flu-like symptoms.  There may be rare serious adverse events that occur as well with many available vaccines; these include allergic reactions and, rarely, conditions that could affect the nervous system. Volunteers will have close oversight and treatment from the study clinical team. </div>\n<div>\n  </div>\n<div>\n Following administration of an HIV vaccine, some HIV-1 tests may give a false positive result. If this occurs, we will use other tests to help distinguish true HIV from a false result due to vaccination. We will provide diagnostic HIV testing certification to show this. Volunteers who test positive due to study vaccination will also be followed up until the HIV test becomes negative including after study completion.  The vaccine to be used has not been proven to protect against HIV infection. Volunteers may acquire HIV during the study and will be linked to appropriate HIV care and treatment. </div>\n<div>\n  </div>\n<div>\n The safety of the vaccine to an unborn baby is not known. Female volunteers joining the study will be advised to use effective family planning methods. For those who become pregnant during the study, we will continue to follow them up until the baby is born and assess for safety of the baby. </div>\n<div>\n  </div>\n<div>\n <strong>How will the study benefit society?  </strong></div>\n<div>\n The information we collect from this study may help develop a safe and effective HIV vaccine which would ultimately benefit the local and global community.</div>\n<div>\n  </div>\n<div>\n <strong>When does the study start and finish?</strong></div>\n<div>\n The study will start shortly after ethical and regulatory approvals have been obtained. The study duration for participants once enrolled is one year. It is envisaged that the study will be completed by Dec 2021. </div>\n<div>\n  </div>\n<div>\n  </div>\n
      • short_titleHIV-CORE 006
      • protocol_noECCT/20/10/01
      • version_no2.1
      • date_of_protocol06-05-2020
      • study_drugChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVconsv4
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Clara Agutu
      • declaration_date114-10-2020
      • declaration_principal_investigatorProf Eduard Sanders (Principal Investigator)
      • declaration_date214-10-2020
      • placebo_presentYes
      • study_objectives<div>\n PRIMARY</div>\n<div>\n Safety</div>\n<ul>\n <li>\n To evaluate the safety and tolerability of a prime boost vaccine regimen utilizing non-replicating simian adenovirus (ChAdOx1) followed by non-replicating poxvirus modified vaccinia virus Ankara (MVA) in adults in Eastern and Southern Africa</li>\n <li>\n Immunogenicity</li>\n <li>\n To evaluate the specific T-cell immune responses induced by the ChAdOx1.tHIVconsv1 followed by MVA.tHIVconsv3&4 vaccines in vaccine recipients.</li>\n</ul>\n<div>\n SECONDARY</div>\n<ul>\n <li>\n To assess tHIVconsvX-specific T-cell responses of for their frequency, breadth and duration in vaccine recipients.</li>\n <li>\n To assess functional T-cell responses in vaccine recipients that inhibit replication in vitro of viruses of major HIV-1 clades A, B, C and D.</li>\n</ul>\n<div>\n EXPLORATORY</div>\n<ul>\n <li>\n To assess induction of plurifunctional tHIVconsvX-specific memory T cells in the vaccine recipients.</li>\n <li>\n Characterization of the gut microbiome composition and richness.</li>\n <li>\n Feasibility of recruiting required sample size across all sites within 16 weeks</li>\n <li>\n Feasibility of retaining at least 90% of enrolled volunteers to end of study.</li>\n</ul>\n
      • principal_inclusion_criteria<div>\n Study Population</div>\n<div>\n The study population consists of healthy HIV-uninfected male or female adults aged 18-50 years, who are at low risk of HIV infection, based on a HIV risk assessment at screening, in Kenya, Uganda and Zambia.</div>\n<div>\n  </div>\n<div>\n Inclusion Criteria</div>\n<ul>\n <li>\n Healthy male and female as assessed by a medical history, physical exam, and laboratory tests.</li>\n <li>\n At low risk of HIV infection and willing to maintain low-risk behaviour for the duration of the trial. Individuals from key populations are not excluded provided they are assessed to be at low risk of HIV infection at screening and are willing to maintain low-risk behaviour during the study.</li>\n <li>\n At least 18 years of age on the day of screening and have not reached their 51st birthday on the day of the first vaccination.</li>\n <li>\n Willing and able to give informed consent for participation in the trial before any study-related procedures are performed. Volunteers will pass an Assessment of Understanding before signing the consent form.</li>\n <li>\n Willing to comply with the requirements of the protocol and be available for follow up for the planned duration of the study.</li>\n <li>\n Willing to undergo HIV testing, risk reduction counselling, receive HIV test results</li>\n <li>\n All sexually active males (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented non-barrier method of birth control) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until 4 months after the last vaccination.</li>\n <li>\n If a female of childbearing potential, willing to use an effective non-barrier method of contraception (hormonal contraceptive or intrauterine device) from at least 2 weeks prior to first vaccination until at least 4 months after the last study vaccination. If not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level >40 IU/L) or surgically sterile: no additional contraception required.</li>\n <li>\n All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to each study vaccination.</li>\n <li>\n Willing to forego donations of blood or any other tissues during the trial and, for those who test positive for HIV antibodies due to vaccination (vaccine-induced seropositivity/ reactivity), until the anti-HIV antibody titres become undetectable.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Confirmed HIV-1 or HIV-2 infection</li>\n <li>\n Receipt of any vaccine in the previous 28 days or planned receipt within 28 days of Investigational Medicinal Product.</li>\n <li>\n Participation in another clinical trial of an Investigational Medicinal Product currently, within the previous 3 months or expected participation during the study.</li>\n <li>\n Receipt of another investigational HIV vaccine candidate or investigational adenoviral vectored vaccine (Note: receipt of an HIV vaccine placebo will not exclude a volunteer from participation if documentation is available and the Medical Monitor gives approval).</li>\n</ul>\n<div>\n <ul>\n <li>\n Receipt of blood transfusion or blood-derived products within the previous 4 months or expectation of receiving blood products during the study period.</li>\n <li>\n Receipt of immunoglobulin products within the previous 3 months.</li>\n <li>\n If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last study vaccination; or lactating.</li>\n <li>\n Any clinically relevant abnormality on history or examination such as:\n <ul>\n <li>\n Any confirmed or suspected history of immunodeficiency including recurrent severe infections;</li>\n <li>\n Use of systemic corticosteroids for >14 days (use of topical or inhaled steroids is permitted) within the previous 6 months;</li>\n <li>\n Immunosuppressive, anti-cancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months.</li>\n <li>\n History of splenectomy.</li>\n <li>\n History of autoimmune disease</li>\n <li>\n Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions). (Note: a volunteer that states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience is eligible)</li>\n <li>\n History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, or clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow up).</li>\n <li>\n History of cancer (except basal cell carcinoma of the skin)</li>\n <li>\n Asthma that is not well controlled.</li>\n <li>\n History of allergic disease or reactions likely to be exacerbated by any component of the vaccine</li>\n <li>\n History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema).</li>\n <li>\n History of Guillain-Barre syndrome.</li>\n <li>\n Confirmed diagnosis of active or chronic hepatitis B, hepatitis C, active syphilis and/or active tuberculosis</li>\n <li>\n Seizure disorder: an individual who has had a seizure in the last 3 years is excluded (Not excluded: an individual with a history of seizures who has neither required medication nor had a seizure for three or more years).</li>\n <li>\n History of serious psychiatric conditions or any psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.</li>\n <li>\n Substance abuse disorder that precludes compliance with the protocol as assessed by the investigator.</li>\n <li>\n Any clinically significant acute or chronic medical condition that is considered unstable/progressive, or in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study</li>\n </ul>\n </li>\n <li>\n Abnormal clinically significant abnormal finding on screening biochemistry or haematology blood, or urinalysis, including but not limited to:</li>\n <li>\n <u>Haematology:</u>\n <ul>\n <li>\n Haemoglobin - <9.5 g/dl in females; <11.0 g/dl in males</li>\n <li>\n Absolute Neutrophil Count (ANC) – ≤1,000/mm3</li>\n <li>\n ï‚· Absolute Lymphocyte Count (ALC) – ≤650/mm3</li>\n <li>\n ï‚· Platelets - <100,000 cells/mm3</li>\n </ul>\n </li>\n </ul>\n</div>\n<div>\n <ul>\n <li>\n <u>Chemistry</u>\n <ul>\n <li>\n Creatinine >1.1 x upper limit of normal (ULN)</li>\n <li>\n AST >1.25 x ULN</li>\n <li>\n ALT >1.25 x ULN</li>\n </ul>\n </li>\n <li>\n Urinalysis\n <ul>\n <li>\n Clinically significant abnormal dipstick confirmed by microscopy:</li>\n <li>\n Protein = 2+ or more</li>\n <li>\n Blood = 2+ or more (not due to menses)</li>\n </ul>\n </li>\n <li>\n Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the study</li>\n <li>\n If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.</li>\n <li>\n NOTE: Investigators should ensure that all study enrolment criteria have been met at the end of the screening period. If a volunteer’s status changes at any time before the 1st dose of the study drug is given that they now meet an exclusion criterion, they should be excluded from participation in the study.</li>\n </ul>\n</div>\n<p>\n  </p>\n
      • primary_end_points<div>\n PRIMARY</div>\n<div>\n Safety</div>\n<ul>\n <li>\n Proportion of volunteers with local and systemic reactogenicity events from Day 0 to Day 7 post vaccination</li>\n <li>\n Proportion of volunteers with Grade 3 or 4 unsolicited adverse events through 28 days post final vaccination</li>\n <li>\n Proportion of volunteers with vaccine related serious adverse events (SAEs) collected throughout the study period</li>\n</ul>\n<div>\n Immunogenicity</div>\n<ul>\n <li>\n Proportion of vaccine recipients developing HIV-1-specific T-cell responses</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:208px;\">\n <p>\n <strong>Name</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n <strong>Designation</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n <strong>Qualifications </strong></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Investigators</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Prof Eduard Sanders</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n MD, MPH, PhD</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Eunice Nduati</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Research Scientist- Immunology</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc, MSc, PhD</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n <strong>Clinical team^a</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Dr Clara Agutu</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Medical Officer/Trial Clinician and Study Coordinator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n MBChB, MPH, MSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Fredrick Ogadah</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Clinical Officer/ Trial Clinician</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Alex Thion’go</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Clinical Officer/ Trial Clinician</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Pharmacy</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Jimmy Shangala</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Trial Pharmacist (Pharmacist of Record)</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BPharm</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Mwaganyuma Mwatasa</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Trial Pharmacist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BPharm</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Beatrice Wavinya</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Pharmaceutical Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Andrew Guantai</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Pharmaceutical Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Regulatory</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Jennifer Kanungi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Regulatory Affairs</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip, PG Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Esther Ndiangui</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Quality Officer</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n <strong>Administration </strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Lucie Ikumi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Project Administrator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Brenda Nekesa</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Administrative Assistant/Reception</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Community Engagement</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Evans Gichuru</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Community Liaison Officer</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BA</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Dancan Otieno</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Community Facilitator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Khamisi Shilingi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Research Counselor</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Alex Kigoro</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Research Counselor</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Data Management </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Elizabeth Wahome</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Data Manager</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc, MSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Esther Yaa</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Senior Data Clerk</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Fanis Kiteki</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Data Clerk</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Laboratory ^b </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Kelly Ramko</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Manager</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n John Mwambi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Senior Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip, Higher Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Clara Karani</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Margaret Nunah</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n James Chemweno</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n ^aSupported by the Clinical Trials Facility, Kilifi</p>\n<p>\n ^bSupported by the Clinical Trials Laboratory and Main KEMRI-Wellcome Trust Research Programme (KWTRP) laboratory in Kilifi</p>\n
      • other_details_explanation<div>\n The proposed regimen of ChAdOx1.tHIVconsv1 (C1) and MVA.tHIVconsv3 + MVA.tHIVconsv4 (M3M4) vaccines have not been tested together in humans before.</div>\n<div>\n However, MVA.tHIVconsv3 and MVA.tHIVconsv4 were administered to participants in the USA in a phase 1 pilot study to evaluate the safety and immunogenicity of the HIV-1 vaccines entitled ‘MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) in HIV-1-infected adults suppressed on Antiretroviral therapy – The M&M Study’ (NCT03844386). As of May 2020, 14 individuals have been enrolled in the study, 11 of whom have received either vaccinations of MVA.tHIVconsv3 or MVA.tHIVconsv4 alone or MVA.tHIVconsv3 and MVA.tHIVconsv4 together. Screenings and enrolments have been suspended, effective 9th March 2020 in light of current restrictions related to COVID-19.</div>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Medical and Healthcare products Regulatory Agency (MHRA), UK approval dated 30 Aril 2020</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationOne year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Normal Saline
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites2
      • multi_country_listKenya, Uganda and Zambia
      • data_monitoring_committeeYes
      • total_enrolment_per_site22
      • total_participants_worldwide88
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePaola
      • investigator1_middle_name
      • investigator1_family_nameCicconi
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressThe Jenner Institute, University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital, Old Road, Oxford, OX3 7LE, United Kingdom.
      • investigator1_telephone+44 (0)1865 611413
      • investigator1_emailpaola.cicconi@ndm.ox.ac.uk
      • organisations_transferred_Yes
      • number_participants44
      • notification
      • approval_date19-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-01-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonConditional approval provided until participants insurance cover is provided
      • final_report<p>\n <strong>HIV-CORE 006 Design Summary</strong></p>\n<p>\n HIV-CORE 006 was a double-blind placebo-controlled trial, in which the HIVconsvX mosaic immunogens were delivered by a prime-boost regimen of non-replicating simian adenovirus ChAdOx1 followed by non-replicating poxvirus MVA. Volunteers were randomised to receive either the vaccine regimen or placebo at 2 vaccination visits 4 weeks apart. The vaccine regimen consisted of a single mosaic prime ChAdOx1.tHIVconsv1 (C1) and a dual boost of MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) administered simultaneously in vaccine regimen C1-M3M4. The trial recruited healthy African adults 18-50 years of age, who were HIV-uninfected and at low risk of HIV infection.</p>\n<p>\n  </p>\n<p>\n 89 healthy men and women were randomised, 88 vaccinated to receive either the vaccine regimen or placebo in a ratio of 72:16 (figure 1):</p>\n<p style=\"margin-left:.5in;\">\n •           Vaccine Arm C1 prime followed by M3M4 boost at 4 weeks after enrolment; 72 vaccine recipients;</p>\n<p>\n •           Placebo Arm; 16 placebo recipients</p>\n<p>\n  </p>\n<p>\n To maintain blinding, all volunteers received two injections with half dose into the deltoid region of each arm of C1 or placebo at enrolment, and two injections of M3 or placebo into one deltoid region and M4 or placebo into the other) at 4 weeks after enrolment.</p>\n<p>\n  </p>\n<p>\n <img height=\"541\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image002.png\" width=\"416\" /></p>\n<p>\n <strong>Figure 1: CONSORT diagram</strong></p>\n<p>\n  </p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n  </p>\n<p>\n <strong>PRIMARY</strong></p>\n<p>\n <strong>Safety</strong></p>\n<ul>\n <li>\n To evaluate the safety and tolerability of a prime boost vaccine regimen utilizing non-replicating simian adenovirus (ChAdOx1) followed by non-replicating poxvirus modified vaccinia virus Ankara (MVA) in adults in Eastern and Southern Africa</li>\n</ul>\n<p>\n <strong>Immunogenicity</strong></p>\n<ul>\n <li>\n To evaluate the specific T-cell immune responses induced by the ChAdOx1.tHIVconsv1 followed by MVA.tHIVconsv3&4 vaccines in vaccine recipients.</li>\n</ul>\n<p>\n <strong>SECONDARY</strong></p>\n<ul>\n <li>\n To assess tHIVconsvX-specific T-cell responses of for their frequency, breadth and duration in vaccine recipients.</li>\n <li>\n To assess functional T-cell responses in vaccine recipients that inhibit replication in vitro of viruses of major HIV-1 clades A, B, C and D.</li>\n</ul>\n<p>\n <strong>EXPLORATORY</strong></p>\n<ul>\n <li>\n To assess induction of plurifunctional tHIVconsvX-specific memory T cells in the vaccine recipients.</li>\n <li>\n Characterization of the gut microbiome composition and richness.</li>\n <li>\n Feasibility of recruiting required sample size across all sites within 16 weeks</li>\n <li>\n Feasibility of retaining at least 90% of enrolled volunteers to end of study.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Research Ethics Committee and Regulatory Approvals </strong></p>\n<p>\n HIV-CORE 006 (NCT04553016) was a double-blind, randomized, placebo-controlled, first-in-man (parallel to HIV-CORE 005.2; NCT04586673), phase 1 clinical trial at four clinical sites in Uganda, Kenya, and Zambia. The study was sponsored by the University of Oxford (UOXF). Approvals for HIV-CORE 006 were granted as follows: MRC/UVRI and London School of Hygiene and Tropical Medicine (MUL) Uganda Research Unit, Masaka: approved by Uganda Virus Research Institute REC (GC/127/20/06/761), Uganda National Council for Science and Technology (HS844ES), and National Drug Authority (CTC 0171/2021); KEMRI-Wellcome Trust Research Programme (KWTRP), Kilifi: approved by Clinical Science Committee (CSC 180), KEMRI Scientific and Ethics Review Unit (SERU 4025) and Pharmacy and Poisons Board (PPB/ECCT/20/10/01/2021); Kenya AIDS Vaccine Initiative-Institute of Clinical Research (KAVI-ICR), University of Nairobi, Nairobi: approved by Kenyatta National Hospital University of Nairobi Ethics Research Committee (P863/10/2019), National Commission for Science, Technology & Innovation (NACOSTI/P/23/23155) and PPB (PPB/ECCT/20/06/09/2020); Center for Family Health Research Zambia (CFHRZ, formerly ZEHRP), Lusaka: approved by the University of Zambia Biomedical Research Ethics Committee (UNZABREC 495-2019) and Zambia Medicines Regulatory Authority (CT 098); and by Oxford Tropical Research Ethics Committee (OXTREC 56-19). The study was conducted according to the principles of the Declaration of Helsinki (2008) and complied with the International Conference on Harmonization Good Clinical Practice guidelines and Good Participatory Practices.</p>\n<p>\n  </p>\n<p>\n <strong>The study populations in Eastern and Southern Africa</strong></p>\n<p>\n The trial was activated at the CFHRZ-Lusaka site on 15 July 2021 and the final scheduled visit by the last participant was attended on 02November 2022. Each of the CRCs in Uganda, Kenya and Zambia carried out recruitment according to their site-specific recruitment plans in compliance with the protocol’s defined inclusion/exclusion criteria and conducted study visits according to protocol’s defined schedule of events. Together over the four CRCs, 186 subjects were screened for eligibility and 89 were  randomized and 88 dosed. The mean age of the participants was 31 years (range 19-50) and 57 (64%) were male. For the C1 vaccine, HIV-CORE 006 was the first-in-man study, which ran in parallel with the C1 dose escalation trial HIV-CORE 005.2 in the UK. Subjects were randomized to receive the standard doses of vaccines in regimen C1-M3M4 (n=72) or placebo (n=16). Standard vaccine doses were determined and used in previous trials of simian adenovirus and poxvirus-vectored vaccines. The follow-up period was 308 days after vaccination. The volunteer recruitment is summarized in table 1. Three participants (2 CFHRZ, 1 KAVI-ICR) were reported pregnant, 3 participants (following dosing) were terminated from the study of whom 1 (KEMRI) was Lost To Follow-up. There were 41 recorded protocol deviations, and 85 participants (22 from CFHRZ, 21 from KEMRI, 20 from KAVI-ICR and 22 from MUL) completed the study. Table 2 summarises the demographics.</p>\n<p>\n  </p>\n<p>\n <strong>Table 1: Recruitment by sites</strong></p>\n<p>\n  </p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n <strong>Site</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Volunteers</strong></p>\n <p align=\"center\">\n <strong>screened</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Females</strong></p>\n <p align=\"center\">\n <strong>screened</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Males</strong></p>\n <p align=\"center\">\n <strong>screened</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Volunteers</strong></p>\n <p align=\"center\">\n <strong>screened out</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Volunteers</strong></p>\n <p align=\"center\">\n <strong>enrolled</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Females</strong></p>\n <p align=\"center\">\n <strong>enrolled</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Males</strong></p>\n <p align=\"center\">\n <strong>enrolled</strong></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n MUL</p>\n </td>\n <td>\n <p align=\"center\">\n 47 (100%)</p>\n </td>\n <td>\n <p align=\"center\">\n 18 (38%)</p>\n </td>\n <td>\n <p align=\"center\">\n 29 (62%)</p>\n </td>\n <td>\n <p align=\"center\">\n 25 (53%)</p>\n </td>\n <td>\n <p align=\"center\">\n 22 (47%)</p>\n </td>\n <td>\n <p align=\"center\">\n 5 (11%)</p>\n </td>\n <td>\n <p align=\"center\">\n 17 (36%)</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n KEMRI</p>\n </td>\n <td>\n <p align=\"center\">\n 50 (100%)</p>\n </td>\n <td>\n <p align=\"center\">\n 9 (18%)</p>\n </td>\n <td>\n <p align=\"center\">\n 41 (82%)</p>\n </td>\n <td>\n <p align=\"center\">\n 27 (54%)</p>\n </td>\n <td>\n <p align=\"center\">\n 23 (46%)</p>\n </td>\n <td>\n <p align=\"center\">\n 2 (4%)</p>\n </td>\n <td>\n <p align=\"center\">\n 21 (42%)</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n KAVI-ICR</p>\n </td>\n <td>\n <p align=\"center\">\n 62 (100%)</p>\n </td>\n <td>\n <p align=\"center\">\n 32 (52%)</p>\n </td>\n <td>\n <p align=\"center\">\n 30 (48%)</p>\n </td>\n <td>\n <p align=\"center\">\n 34 (55%)</p>\n </td>\n <td>\n <p align=\"center\">\n 22 (35%)</p>\n </td>\n <td>\n <p align=\"center\">\n 14 (23%)</p>\n </td>\n <td>\n <p align=\"center\">\n 8 (13%)</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n CFHRZ</p>\n </td>\n <td>\n <p align=\"center\">\n 27 (100%)</p>\n </td>\n <td>\n <p align=\"center\">\n 12 (44%)</p>\n </td>\n <td>\n <p align=\"center\">\n 15 (56%)</p>\n </td>\n <td>\n <p align=\"center\">\n 5 (19%)</p>\n </td>\n <td>\n <p align=\"center\">\n 22 (81%)</p>\n </td>\n <td>\n <p align=\"center\">\n 11 (41%)</p>\n </td>\n <td>\n <p align=\"center\">\n 11 (41%)</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <strong>Total</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>186 (100%)</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>71 (38%)</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>115 (62%)</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>91 (49%)</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>89 (48%)</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>32 (17%)</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>57 (31%)</strong></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>Table 2: Demographics</strong></p>\n<p>\n  </p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p align=\"center\">\n <strong>MUL</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>KEMRI</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>KAVI-ICR</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>CFHRZ</strong></p>\n </td>\n <td>\n <p align=\"center\">\n <strong>Overall 006</strong></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Sex</p>\n </td>\n <td>\n <p>\n Male</p>\n </td>\n <td>\n <p align=\"center\">\n 17 (77%)</p>\n </td>\n <td>\n <p align=\"center\">\n 21 (91%)</p>\n </td>\n <td>\n <p align=\"center\">\n 8 (36%)</p>\n </td>\n <td>\n <p align=\"center\">\n 11 (50%)</p>\n </td>\n <td>\n <p align=\"center\">\n 57 (64%)</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n Female</p>\n </td>\n <td>\n <p align=\"center\">\n 5 (23%)</p>\n </td>\n <td>\n <p align=\"center\">\n 2 (9%)</p>\n </td>\n <td>\n <p align=\"center\">\n 14 (64%)</p>\n </td>\n <td>\n <p align=\"center\">\n 11 (50%)</p>\n </td>\n <td>\n <p align=\"center\">\n 32 (36%)</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Age (years)</p>\n </td>\n <td>\n <p>\n Mean</p>\n </td>\n <td>\n <p align=\"center\">\n 29</p>\n </td>\n <td>\n <p align=\"center\">\n 34</p>\n </td>\n <td>\n <p align=\"center\">\n 27</p>\n </td>\n <td>\n <p align=\"center\">\n 34</p>\n </td>\n <td>\n <p align=\"center\">\n 31</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n Range</p>\n </td>\n <td>\n <p align=\"center\">\n 19-39</p>\n </td>\n <td>\n <p align=\"center\">\n 27-50</p>\n </td>\n <td>\n <p align=\"center\">\n 19-37</p>\n </td>\n <td>\n <p align=\"center\">\n 24-47</p>\n </td>\n <td>\n <p align=\"center\">\n 19-50</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Height (cm)</p>\n </td>\n <td>\n <p>\n Range</p>\n </td>\n <td>\n <p align=\"center\">\n 148-190</p>\n </td>\n <td>\n <p align=\"center\">\n 163-182</p>\n </td>\n <td>\n <p align=\"center\">\n 154-186</p>\n </td>\n <td>\n <p align=\"center\">\n 150-185</p>\n </td>\n <td>\n <p align=\"center\">\n 148-190</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Body mass (kg)</p>\n </td>\n <td>\n <p>\n Range</p>\n </td>\n <td>\n <p align=\"center\">\n 46-91</p>\n </td>\n <td>\n <p align=\"center\">\n 41-84</p>\n </td>\n <td>\n <p align=\"center\">\n 46-106</p>\n </td>\n <td>\n <p align=\"center\">\n 45-98</p>\n </td>\n <td>\n <p align=\"center\">\n 45-106</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>The vaccine was well tolerated </strong></p>\n<p>\n Evaluation of the safety and tolerability of a prime-boost vaccine regimen was one of the trial’s primary objectives. Overall, all three vaccine components C1, M3 and M4 were well tolerated with no serious adverse events (SAEs) recorded. The most frequently reported AEs were those typically seen in response to viral vectored vaccines including pain at the injection site, headache, general malaise, fatigue, and myalgia. In line with data from clinical trials using similar vaccines, C1 tended to be less reactogenic (249/302 82% grade 1, 53/302 18% grade 2 and no grade 3) than M3M4 (172/310; 55% grade 1, 130/310; 41% and 8/310; 4% grade 3) (figure 2). All AEs resolved spontaneously within 72 hours. Placebo recipients recorded 31 local and 45 systemic AEs.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <img height=\"236\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image004.png\" width=\"314\" /></p>\n<p>\n <strong>Figure 2: Maximum severity of adverse events </strong></p>\n<p>\n Number of local (top) and systemic (bottom) solicited adverse events over 6 days after vaccine administration. The bars are colour-coded as indicated below the graphs according to the severity of the adverse events. P1 = the first administration of placebo; P2 – the second administration of placebo.</p>\n<p>\n Although expected, the relatively high frequency of solicited adverse reactions with the risk of severe (grade 3) symptoms triggered an ad-hoc safety meeting. The independent Data Monitoring and Ethics Committee (DMEC) reviewed the cases of two participants:</p>\n<ul>\n <li>\n One participant suffered severe headaches, malaise, fatigue and arthralgia following vaccination with MVA.tHIVconsv3 and MVA.tHIVconsv4. This was accompanied by a fever that peaked at 38.8 ËšC and associated with a severe lymphopenia 1 day after vaccination. He was managed symptomatically, including administration of paracetamol, and his symptoms subsided by day 2 after vaccination.</li>\n <li>\n A second participant suffered severe headaches, malaise, fatigue, myalgia and arthralgia following vaccination with MVA.tHIVconsv3 and MVA.tHIVconsv4. This was accompanied by a fever that peaked at 39.1 ËšC and symptoms of dyspepsia. She received symptomatic management that included administration of paracetamol. The severity of symptoms subsided by day 2 following vaccination when she reported that she had a mild headache but was able to function.</li>\n</ul>\n<p>\n  </p>\n<p>\n Considering the severity of symptoms, and the frequency with which they had occurred at the time among trial participants, the DMEC recommended that participants should receive a dose of anti-pyretic medications prior to administration of the MVA-vectored vaccines and should be advised to take additional doses of paracetamol, as required, over the following 24 to 48 hours.</p>\n<p>\n  </p>\n<p>\n Thirty-two participants reported 53 unsolicited adverse events (table 3). The majority was grade 1 to grade 2 in severity and all resolved without sequalae. Only three unsolicited adverse events were considered possibly related to vaccination, they resolved within 72 hours of onset and included mild fatigue and headache (11 days after the booster vaccination), moderate acute gastroenteritis (2 days after the first vaccination). They all occurred in the vaccination arm.</p>\n<p>\n  </p>\n<p>\n <strong>Table 3: Unsolicited Adverse Events Observed during the trial.</strong></p>\n<p>\n  </p>\n<table align=\"center\" border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"662\">\n <tbody>\n <tr>\n <td style=\"width:82px;height:44px;\">\n <p style=\"margin-left:5.25pt;\">\n Volunteer ID</p>\n </td>\n <td style=\"width:130px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n AE description</p>\n </td>\n <td style=\"width:90px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n Severity</p>\n </td>\n <td style=\"width:76px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n Onset days after vaccination</p>\n </td>\n <td style=\"width:71px;height:44px;\">\n <p>\n Days between onset and resolution</p>\n </td>\n <td style=\"width:94px;height:44px;\">\n <p style=\"margin-left:5.15pt;\">\n Relation to IP</p>\n </td>\n <td style=\"width:117px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n Outcome</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619004</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n ABNORMAL VAGINAL DISCHARGE SYNDROME</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 26</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 12</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:44px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619006</p>\n </td>\n <td style=\"width:130px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n UPPER RESPIRATORY TRACT INFECTION</p>\n </td>\n <td style=\"width:90px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:44px;\">\n <p>\n 16</p>\n </td>\n <td style=\"width:71px;height:44px;\">\n <p>\n 7</p>\n </td>\n <td style=\"width:94px;height:44px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:44px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619006</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n MALARIA</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 14</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 9</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619024</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n HEADACHE</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 24</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 10</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619024</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n CHILLS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 24</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 10</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619041</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n SOFT TISSUE INJURY</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 26</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619041</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n RIGHT ANKLE SPRAIN</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 26</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 8</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619042</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n UNSPECIFIC FEBRILE ILLNESS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 13</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n Unlikely</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00619047</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n TONSILLITIS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 20</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 2</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00621006</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n ARTHRITIS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 8</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:32px;\">\n <p style=\"margin-left:5.25pt;\">\n N00621006</p>\n </td>\n <td style=\"width:130px;height:32px;\">\n <p style=\"margin-left:5.3pt;\">\n BILATERAL LOWER LIMB MUSCLE PAINS</p>\n </td>\n <td style=\"width:90px;height:32px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:32px;\">\n <p>\n 15</p>\n </td>\n <td style=\"width:71px;height:32px;\">\n <p>\n 18</p>\n </td>\n <td style=\"width:94px;height:32px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:32px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:33px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622006</p>\n </td>\n <td style=\"width:130px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n COUGH</p>\n </td>\n <td style=\"width:90px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:33px;\">\n <p>\n 5</p>\n </td>\n <td style=\"width:71px;height:33px;\">\n <p>\n 7</p>\n </td>\n <td style=\"width:94px;height:33px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622019</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n UPPER RESPIRATORY TRACT INFECTION</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 2</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 5</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622027</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n VAGINAL CANDIDIASIS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 26</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 5</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622040</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n TOOTH ACHE</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 19</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622044</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n FATIGUE</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n Possible (Yes</p>\n <p style=\"margin-left:5.15pt;\">\n expected)</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622044</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n HEADACHE</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = mild</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n Possible (Yes</p>\n <p style=\"margin-left:5.15pt;\">\n expected)</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00622048</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n CELLULITIS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 10</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623003</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n HEADACHE</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 18</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 1</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:33px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623003</p>\n </td>\n <td style=\"width:130px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n UPPER RESPIRATORY TRACT INFECTION</p>\n </td>\n <td style=\"width:90px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = moderate</p>\n </td>\n <td style=\"width:76px;height:33px;\">\n <p>\n 23</p>\n </td>\n <td style=\"width:71px;height:33px;\">\n <p>\n 6</p>\n </td>\n <td style=\"width:94px;height:33px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:33px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623005</p>\n </td>\n <td style=\"width:130px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n ARTHRALGIA OF THE KNEES</p>\n </td>\n <td style=\"width:90px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = moderate</p>\n </td>\n <td style=\"width:76px;height:33px;\">\n <p>\n 12</p>\n </td>\n <td style=\"width:71px;height:33px;\">\n <p>\n 2</p>\n </td>\n <td style=\"width:94px;height:33px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:32px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623008</p>\n </td>\n <td style=\"width:130px;height:32px;\">\n <p style=\"margin-left:5.3pt;\">\n ACUTE ENTERITIS</p>\n </td>\n <td style=\"width:90px;height:32px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = moderate</p>\n </td>\n <td style=\"width:76px;height:32px;\">\n <p>\n 2</p>\n </td>\n <td style=\"width:71px;height:32px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:94px;height:32px;\">\n <p style=\"margin-left:5.15pt;\">\n Possible (Not Expected)</p>\n </td>\n <td style=\"width:117px;height:32px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623016</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n FLU LIKE ILLNESS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 3 = severe</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 26</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 8</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n Unlikely</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:33px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623017</p>\n </td>\n <td style=\"width:130px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n BILATERAL EYE PAIN</p>\n </td>\n <td style=\"width:90px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:33px;\">\n <p>\n 1</p>\n </td>\n <td style=\"width:71px;height:33px;\">\n <p>\n 1</p>\n </td>\n <td style=\"width:94px;height:33px;\">\n <p style=\"margin-left:5.15pt;\">\n Unlikely</p>\n </td>\n <td style=\"width:117px;height:33px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623021</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n PAIN AND DISCOLORATION AT VENEPUNCTURE SITE - RIGHT FOREARM</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 7</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:14px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623021</p>\n </td>\n <td style=\"width:130px;height:14px;\">\n <p style=\"margin-left:5.3pt;\">\n UPPER RESPIRATORY TRACT INFECTION</p>\n </td>\n <td style=\"width:90px;height:14px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:14px;\">\n <p>\n 20</p>\n </td>\n <td style=\"width:71px;height:14px;\">\n <p>\n 6</p>\n </td>\n <td style=\"width:94px;height:14px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:14px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623022</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n UPPER RESPIRATORY TRACT INFECTION</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n Unlikely</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623023</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n FLU LIKE ILLNESS</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 2 = Moderate</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 25</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 1</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:82px;height:29px;\">\n <p style=\"margin-left:5.25pt;\">\n N00623024</p>\n </td>\n <td style=\"width:130px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n HEADACHE</p>\n </td>\n <td style=\"width:90px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n 1 = Mild</p>\n </td>\n <td style=\"width:76px;height:29px;\">\n <p>\n 28</p>\n </td>\n <td style=\"width:71px;height:29px;\">\n <p>\n 11</p>\n </td>\n <td style=\"width:94px;height:29px;\">\n <p style=\"margin-left:5.15pt;\">\n No relationship</p>\n </td>\n <td style=\"width:117px;height:29px;\">\n <p style=\"margin-left:5.3pt;\">\n Resolved, no residual effects</p>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n<p>\n  </p>\n<p>\n One participant showed severe lymphopenia within 24 hours of the second vaccination.  The number of total lymphocytes dropped from 1000 to 350 lymphocytes per microliter of blood. Lymphocytes count recovered at the following appointment, and the participant was completely asymptomatic. Similar changes have been observed in other trials using the same vaccines and were considered an effect of peripheral lymphocytes migration to the lymph nodes rather than a true lymphopenia.  No other severe laboratory abnormalities detected. One participant had mild thrombocytopenia from baseline through the study; for this reason, it was considered not related to the vaccination with MVA vectored vaccines. Table 4 shows all the lab abnormalities observed during the HIV-CORE 006 trial.</p>\n<p>\n  </p>\n<p>\n <strong>Table 4: Lab abnormalities observed during the HIV-CORE 006 trial.</strong></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong><img height=\"226\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image006.png\" width=\"601\" /></strong></p>\n<p>\n  </p>\n<p>\n In summary, the vaccines used in this clinical trial had an acceptable safety profile. The vast majority of the adverse events were expected and mild to moderate in nature. They all resolved within a few days without sequalae.</p>\n<p>\n  </p>\n<p>\n <strong>The HIVconsvX vaccination induced strong broadly specific T-cell responses</strong></p>\n<p>\n One of the primary objectives of the HIV-CORE 006 trial was to determine the proportion of vaccine recipients developing HIV-1-specific T-cell responses. The HIVconsvX-specific T cells induced by the vaccination were enumerated locally at each of the four CRCs using the same shared fresh IFN-g ELISPOT assay and reagents. For this objective, frequencies were compared before and after vaccination on days 0 and 35, respectively. Fresh ex vivo PBMCs were tested against 10 peptide pools P1 to P10 of 15-mer peptides overlapping by 11 amino acids corresponding to both mosaics of the entire HIVconsvX immunogens. Both the clinical and laboratory teams were blinded for the vaccine vs. placebo allocation. The C1-M3M4 vaccine regimen was highly immunogenic and increased HIV-1-specific responses in 70/71 (99%) analyzed recipients of the vaccine.</p>\n<p>\n The trial’s secondary objectives were to assess the magnitude, breadth, and duration of vaccine-elicited responses. These parameters were determined before vaccination (day 0), at peak of responses 1 week after M3M4 (day 35), and at the end of the study 40 weeks later (day 336). Across the four sites, HIVconsvX-specific T-cells peaked at median (range) 2,330 (80-16,750) SFU/10⁶ PBMC and recognized median (range) 8/10 (0-10) peptide pools (figure 3 and table 5). On average, these frequencies decreased 4·6-fold over the follow-up period. Responses in the placebo recipients were a median (range) 85 (10-460) SFU/10⁶ PBMCs.</p>\n<p>\n  </p>\n<p>\n  <img height=\"120\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image008.png\" width=\"581\" /></p>\n<p>\n <strong>Figure 3: Strong and broad T-cell responses induced in HIV-1-negative individuals by the HIVconsvX vaccines. </strong>Total frequencies determined in an IFN-g ELISPOT assay using HIVconsvX peptide pools P1-P10 corresponding to the two mosaics 1 and 2 of the vaccines on days 0, 35 and 308 shown for each of the four CRCs separately. Dunn’s multiple comparisons test was carried out, whereby the P values are: *** - 0.0001 to 0.001; and **** - <0.0001.</p>\n<p>\n  </p>\n<p>\n <strong>Table 5: Peak total magnitude and number of peptide pools out of 10 recognized by the HIVconsvX vaccines.</strong></p>\n<p>\n <img alt=\"A table with numbers and letters\n\nDescription automatically generated\" height=\"143\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image010.png\" width=\"460\" /></p>\n<p>\n  </p>\n<p>\n <strong>HIVconsvX vaccine-elicited T cells can proliferate and exert an effector function</strong></p>\n<p>\n Next, we examined the ‘stemness’ of the vaccine-induced memory cells, that is their ability to proliferate and function. Frozen PBMCs were cultured with individual peptide pools for 10 days and tested in an IFN-g ELISPOT assay against the pool’s peptide pairs (mosaic 1 and mosaic 2). A mean ± SD of 16 ± 18 and median (range) 13 (0-61) 15-mer peptide pairs stimulating ³750 SFU/10⁶ of cultured cells (corresponding to at least 30 SFU above no-peptide background in an assay well with 40,000 cells input) were recognized by the tested vaccine recipients (n=30). This number overestimates the real number targeted epitopes, which can be shared between overlapping 15/11 peptide pairs. All volunteers' tissue types for HLA class I and II were genetically determined for future detailed epitope characterizations (data under QC).</p>\n<p>\n  </p>\n<p>\n <strong>HIVconsvX-specific T cells inhibited viruses derived from four major global clades</strong></p>\n<p>\n Another trial’s secondary objective was to determine the breadth of inhibition of HIV-1 growth by vaccine-induced CD8⁺ T-cell effectors. A virus inhibition assay (VIA) employed infectious molecular clones (IMCs) of HIV-1, which originated from diverse countries and represented major global clades (table 6), maintained physiological levels and functions of the Nef protein, a negative regulatory factor which helps HIV-1 to evade immune responses, and produced the LucR enzyme to quantitate HIV-1 growth. Antigen non-specifically expanded CD8⁺ T-cell effectors were cocultured with IMC-infected volunteers’ autologous CD4⁺ cell targets for 5 days before the LucR activity in the cell lysates was quantified by emitting light. In preliminary results, the effectors demonstrated a broad cross-clade inhibition for most tested volunteers (table 7a-d). In essence, the HIVconsvX vaccination induced CD8⁺ T cells, which showed increased inhibition of median (range) 8 (0-8) IMCs at peak and 8 (0-8) at the end of the study relative to the pre-vaccination time point. While it is not certain how these VIA results translate into in vivo efficacy, they certainly encourage further vaccine development towards assessing clinical benefits it might offer.</p>\n<p>\n  </p>\n<p>\n <strong>Table 6. HIV-1 infectious clones (IMCs) used in VIA</strong></p>\n<p>\n <img alt=\"A table with black text\n\nDescription automatically generated\" height=\"130\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image012.png\" width=\"378\" /></p>\n<p>\n <strong>Table 7a: Cross-clade HIV inhibition in vitro – MUL</strong></p>\n<p>\n <img height=\"794\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image014.png\" width=\"625\" /></p>\n<p>\n  </p>\n<p>\n The 1st column shows ELISPOT data (Magn/Pools = total magnitude as SFU/10⁶ PBMC/Number of recognized pools). P – placebo. The data are shown as relative inhibition (please see Material and Methods). Dark red – inhibition relative to day 0 increased by more than ³1.0 log₁₀; medium red - inhibition relative to day 0 increased by <1.0 log₁₀ to ³0·1 log₁₀; light red - inhibition relative to day 0 increased by <0·1 log₁₀;  no colour – no increase in inhibition relative to pre-vaccination. nd – no data; ivg – insufficient virus growth.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Table 7b: Cross-clade HIV inhibition in vitro – KEMRI</strong></p>\n<p>\n <img height=\"826\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image016.png\" width=\"636\" /></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Table 7c: Cross-clade HIV inhibition in vitro – KAVI-ICR</strong></p>\n<p>\n <img height=\"767\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image018.png\" width=\"599\" /></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Table 7d: Cross-clade HIV inhibition in vitro – CFHRZ</strong></p>\n<p>\n <img height=\"697\" src=\"file:///C:/Users/jkanungi/AppData/Local/Temp/msohtmlclip1/01/clip_image020.png\" width=\"611\" /></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Conclusion</strong></p>\n<p>\n  </p>\n<p>\n As per the trial’s primary endpoints, the C1, M3 and M4 vaccine components were safe and well tolerated, and induced HIVconsvX-specific responses in 70/71 (99%) recipients. The secondary endpoints demonstrated that the vaccine-elicited T-cells peaked at median (range) 2,330 (80-16,750) IFN-g spot-forming units/10⁶ PBMC, recognized 8 (0-10) out of ten peptide pools spanning the HIVconsvX regions, decreased 4·6-fold in magnitude over a six-month follow-up and inhibited HIV-1 derived from four major global clades A, B, C and D. Further T-cells characterizations are in progress with the aim to submit the manuscript for a publication in a high-impact peer-reviewed journal by the end of Q1 2024.</p>\n<p>\n Overall,, the results in sub-Saharan at-risk populations confirm the HIVconsvX vaccine regimen safety and immunogenicity demonstrated in the UK and encourage evaluation of the vaccine’s contribution to efficacy against HIV-1.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <br />\n  </p>\n<p>\n  </p>\n
      • implication_results
      • quantity_imported57
      • quantity_dispensed54
      • quantity_destroyed3
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2025-07-23 12:26:19
      • created2020-09-04 14:19:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id581
        • application_id937
        • given_nameEduard
        • middle_nameJ
        • family_nameSanders
        • qualificationMD, MPH, PhD
        • professional_addressKEMRI/ Wellcome Trust Research Programme, Hospital Road P.O. Box 230-80108 Kilifi, Kenya.
        • telephone+254 723593762
        • emailESanders@kemri-wellcome.org
        • created2020-09-11 09:57:42
        • modified2021-01-26 08:31:19
    • SiteDetail(array)
      • 0(array)
        • id810
        • application_id937
        • county_id3
        • site_nameKEMRI Mtwapa Research Clinic
        • physical_addressKEMRI/ Wellcome Trust Research Programme, Off Hospital Road, Kilifi
        • contact_detailsKEMRI/ Wellcome Trust Research Programme, Hospital Road P.O. Box 230-80108 Kilifi, Kenya.
        • contact_personProf Eduard Sanders
        • site_capacity(null)
        • misc(null)
        • created2020-09-11 09:57:42
        • modified2021-01-26 08:31:19
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id811
        • application_id937
        • county_id47
        • site_nameKAVI-ICR Nairobi
        • physical_addressUniversity of Nairobi, Kenyatta National Teaching and Referral Hospital, Nairobi
        • contact_detailsUniversity of Nairobi, PO Box 19676-00202 Off Ngong Road, Nairobi Kenya
        • contact_personProfessor Walter Jaoko
        • site_capacity(null)
        • misc(null)
        • created2020-09-11 10:26:44
        • modified2021-01-26 08:31:19
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id454
        • application_id937
        • sponsorUniversity of Oxford, United Kingdom
        • sponsor_typeOthers
        • contact_personDr Paola Cicconi
        • addressThe Jenner Institute, University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital, Old Road, Oxford. OX3 7LE United Kingdom
        • telephone_number+44 (0)1865 611413
        • fax_number
        • cell_number+44 (0)1865 611413
        • email_addresspaola.cicconi@ndm.ox.ac.uk
        • created2020-09-11 09:57:42
        • modified2021-01-26 08:31:19
  • 3(array)
    • Application(array)
      • id944
      • user_id637
      • trial_status_id(null)
      • abstract_of_study<p>\n Current methods for diagnosis of schistosomiasis (SCH) rely on detection of parasite eggs in stool or urine by microscopy. These methods are simple but have reduced sensitivity in low prevalence settings in addition to being laborious, time-consuming, as well as the requirement to have expert microscopists to identify parasite eggs accurately. Improved methods of detecting SCH have been or are being developed, but in their current format, are not field-friendly. To support national SCH programmes to reach elimination target as defined by WHO, new and better diagnostic tests need to be developed. To address this gap, the Foundation for Innovative New Diagnostics (FIND) in collaboration with WHO, Mologic and Leiden University Medical Center (LUMC) are developing a new point-of-care (POC) rapid diagnostic test (RDT) (known as the SCH CAA RDT) that aims to support national control programmes to monitor the impact of treatments, and for reassessment mapping. So far, the prototype has only been evaluated using stored serum samples from SCH-infected individuals. Therefore, the aim of this study, to be led by KEMRI, is to evaluate the performance of the prototype RDT using freshly collected samples from SCH infected and non-infected individuals living in Kenya. The study will be carried out in Kwale and Siaya counties where previous studies have found relatively moderate levels of SCH infections. The two sites have been selected, based on the presence of only <em>S.</em> <em>haematobium</em> or only <em>S.</em> <em>mansoni</em> infections, respectively. In each county, one village will be selected and 350 inhabitants (aged ≥5 years and permanent residents in the study area) will be included. In addition, Kiambu County has been selected as a non-endemic area to ensure that a negative “control” pool of samples is made available to evaluate the specificity of the prototype. One village will be selected and 76 inhabitants (aged ≥5 years and permanent residents in the study area) will be included in the study. Individuals will be consecutively enrolled in the study. Stool and urine samples will be collected from participants, each day for three consecutive days, to find out whether they are infected with SCH. In addition, 5 ml venous blood will be drawn from each participant on the first day of sample collection, as well as a 50µl finger prick blood sample. All participants found positive for SCH and soil-transmitted helminths (STH) (also commonly known as intestinal worms) will be treated at the end of the study following national treatment guidelines.</p>\n<p>\n The performance of the SCH CAA prototype RDT will be compared to that of those diagnostic tests currently recommended by the WHO, namely microscopy-based tests. Results from this evaluation study will allow further optimization of the prototype RDT to ensure that it meets the targets defined in the target product profile (TPP). It is envisaged that the RDT will support national SCH programmes to monitor the impact of public health interventions such as mass drug administration (MDA) campaigns as well as for reassessment mapping. </p>\n
      • study_title<p>\n <strong>A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis</strong></p>\n
      • laymans_summary<p>\n <em>Background </em></p>\n<p>\n Schistosomiasis (SCH) or bilharzia (also known as kichocho in the Kiswahili language) is a disease caused by parasitic worms found in freshwater snails, and affects over 250 million people worldwide. The worms infect people by penetrating through the skin during daily routine activities in freshwater bodies (such as in rivers or lakes). The adult worms live in the blood vessels around the urinary bladder or the intestines, where they lay eggs that are passed out in urine or faeces. Currently, bilharzia is detected by examination of faeces and/or urine samples under the microscope to check for eggs. Where infection has been controlled, determining the infection status of individuals by use of a microscope becomes difficult because of fewer number of eggs. Poor detection of infection can result in premature stopping of control activities and resumption of disease. To support programmes for control and/ or elimination of bilharzia, new and better tests for detecting the disease are needed. To address this gap, the Foundation for Innovative New Diagnostics (FIND) together with other partners are developing a new test to be used at the location the patient is presenting with disease with quick results known as the SCH CAA RDT.</p>\n<p>\n <em>What questions are we trying to answer?</em></p>\n<p>\n Most of the development of the SCH CAA RDT has been done using stored frozen blood samples, but before the new test is cleared for manufacturing, it needs to be tested using fresh samples. Results from this evaluation study, to be led by KEMRI, will allow further improvements of the new test to ensure it meets the recommended standards.</p>\n<p>\n <em>Where is the study taking place, how many people does it involve and how are they selected?</em></p>\n<p>\n The study will be carried out in Kwale and Siaya counties where both the urogenital (disease affects the urinary and reproductive areas) and intestinal forms of the disease occur, respectively.  In each county, one village will be selected and 350 people (aged above 5 years and above) will be included in the study. In addition, one village in Kiambu County, where the disease is not found has been selected and samples will be collected from 76 participants to further evaluate performance of the test among people without the disease.</p>\n<p>\n <em>What does the study involve for those who are taking part?</em></p>\n<p>\n After participants agree to participate, stool and urine samples will be collected from them, each day for three consecutive days, to find out whether they have bilharzia. In addition, 5 ml of blood will be collected from each participant on the first day, as well as a tiny amount of blood from the finger. All participants found with bilharzia and other intestinal worms will be treated.</p>\n<p>\n <em>What are the risks and benefits involved in taking part?</em></p>\n<p>\n Participants may experience minor but temporal pain and discomfort during the collection of blood, temporal change in colour on the skin and swelling of the vein. Very rarely, some individuals may experience a sudden drop-in heart rate and blood pressure, leading to profuse sweating, nausea and on rare occasions, fainting. Some participants may find collection of stool and urine samples to be uncomfortable. Treatment will be offered to those individuals found to be infected with bilharzia and other intestinal worms. Individuals might experience some side effects upon treatment with praziquantel, however, those are mild and temporal.</p>\n<p>\n <em>How will the study benefit society?</em></p>\n<p>\n Treatment of infected individuals will also benefit other villagers, as it will contribute to reducing spread of the disease. Community members will also be educated/sensitized on how to control and prevent bilharzia. In the longer-term, the study will have contributed to the development of a new test which will support control efforts and improved identification of villages requiring treatment.</p>\n<p>\n <em>When does the study start and finish?</em></p>\n<p>\n Sample collection and field evaluation of the new test is expected to begin in August 2020 and last for five months. Data entry, data analysis and report writing is expected to be finalized by February 2021.</p>\n<p>\n  </p>\n
      • short_titleSchisto RDT evaluation
      • protocol_noECCT/20/09/06
      • version_no1.0
      • date_of_protocol14-08-2020
      • study_drugN/A
      • disease_conditionSchistosomiasis
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_namePrototype schistosomiasis RDT
      • comparatorYes
      • comparator_nameKato-Katz and Urine Filtration
      • comparator_registeredNo
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssammynjenga@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantProf. Sammy Njenga
      • declaration_date129-09-2020
      • declaration_principal_investigatorProf. Sammy Njenga
      • declaration_date229-09-2020
      • placebo_presentNo
      • study_objectives<ol>\n <li>\n To demonstrate that the sensitivity of the SCH CAA prototype RDT in fresh samples from a SCH endemic area is 95% of currently WHO recommended diagnostic tests with a margin of 10%.</li>\n <li>\n To demonstrate that the specificity of the SCH CAA prototype RDT in fresh samples from a SCH endemic area is 75% of currently WHO recommended diagnostic tests with a margin of 10%.</li>\n <li>\n To demonstrate that the specificity of the SCH CAA prototype RDT in fresh samples from a non – SCH endemic area is 95% of currently WHO recommended diagnostics tests with a margin of 10%.</li>\n</ol>\n
      • principal_inclusion_criteria<ol>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Individuals aged 5 years and above </span></li>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Residents of study areas for a period of at least 1 year </span></li>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Willingness to provide informed consent </span></li>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Willingness to provide stool, urine and blood samples</span></li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Individuals above 100 years of age or who feels/appears unwell </span></li>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Unable to provide a blood and one-day stool and urine sample </span></li>\n <li>\n <span style=\"color: rgb(0, 0, 0); font-family: Arial, Helvetica, sans-serif; font-size: 11px;\">Individual has taken praziquantel within the past 2 months</span></li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n Clinical sensitivity of the SCH CAA prototype RDT in a SCH endemic area</li>\n <li>\n Clinical specificity of the SCH CAA prototype RDT in a SCH endemic area</li>\n <li>\n Clinical specificity of the SCH CAA prototype RDT in a non-endemic area</li>\n</ol>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPrototype schistosomiasis RDT field evaluation
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n A total of 9 investigators are involved in this study. </p>\n<p>\n <strong>1. Sammy Njenga, PhD</strong></p>\n<p>\n Prof. Sammy Njenga is working as a research scientist in the Kenya Medical Research Institute (KEMRI) and is the Principal Investigator (PI) for this study. He has more than 25 years experience in medical research in neglected tropical diseases (NTDs). Prof. Njenga has published more than 100 scientific papers in peer-reviewed journals. He is a member of the World Health Organization Neglected Tropical Diseases Diagnostics Technical Advisory Group (WHO NTD DTAG). He is also a member of the National Technical Advisory Group (TAG) on soil-transmitted helminthiasis and schistosomiasis. Currently, Prof. Njenga is the Chairperson of the National Technical Advisory Group (TAG) on National Programme for Elimination Lymphatic Filariasis.  </p>\n<p>\n <strong>2. Sultani Matendechero, MPharm</strong></p>\n<p>\n Dr. Sultani Matendechero is currently serving as the head of the Division of Vector Borne and Neglected Tropical Diseases in the Ministry of Health in Kenya. His role involves overall management of programme activities. He previously served as the Pharmacist In Charge in Vihiga District Hospital and the coordinator of Malaria Case Management in Western Province, Kenya.</p>\n<p>\n <strong>3. Florence Wakesho, MSc</strong></p>\n<p>\n Florence Wakesho is the current focal person for soil-transmitted helminthiasis and schistosomiasis in the Division of Vector Borne and Neglected Tropical Diseases in the Ministry of Health in Kenya. She is responsible for programme implementation and coordination of county, sub-county and implementing partners.  </p>\n<p>\n <strong>4. Henry Kanyi, MSc</strong></p>\n<p>\n Henry Kanyi is working as a research scientist in the Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC) at KEMRI. He has several years of experience in laboratory management. In 2013 he attended a training on the multiplex ELISA technique using Bio-Plex 200 system in the Cnters for Disease Control & Prevention (CDC) in Atlanta, USA. Henry has also trained on the application of quantitative real-time PCR (qPCR) assay for the detection of infectious diseases at the Noguchi Memorial Institute in Accra, Ghana. The laboratory skills has enabled Henry to support several serosurveillance surveys. </p>\n<p>\n <strong>5. Maurice Odiere, PhD</strong></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">Dr. Maurice Odiere is working as a research scientist in the Kenya Medical Research Institute (KEMRI). His research focuses on mapping of schistosomiasis and its vectors, parasite prevalence and morbidity in adults and young children, assessing parasitological diagnostic tools, immunology and nutritional aspects of infection and evaluating chemotherapy control interventions for both schistosomiasis and STHs, and qualitative studies towards understating of the socio-economic and cultural dynamics of infection. Dr Odiere is currently a Principal Investigator in a study looking at the public health benefits of integrated control programme for schistosomiasis and soil-transmitted helminthiasis in western Kenya and a co-investigator in many studies. He </span></span>has published many articles in peer-reviewed scientific journals.</p>\n<p>\n <strong>6. Humphrey Kariuki Njaanake, PhD</strong></p>\n<p>\n Humphrey Kariuki is a lecturer/ researcher at the University of Nairobi. He has served as a PI in a research study titled, “Urinary Cytokine ELISA: a tool for assessing urinary tract pathology in <em>Schistosoma</em> <em>haematobium</em> infections”. In addition to supervision and mentoring students, Dr. Kariuki he has also published in peer-reviewed journals.  </p>\n<p>\n <strong>7. Sarah Nogaro, PhD</strong></p>\n<p>\n Dr. Sarah Nogaro is a scientific officer in the NTD program at the Foundation for Innovative New Diagnostics <u>(</u>FIND), Switzerland. She has vast experience in project management, product development, planning, managing and monitoring studies evaluating schistosomiasis diagnostic tests in low-resource settings. Previously, Dr. Nogaro provided technical support to Ministries of Health and Education in setting up national control programmes against schistosomiasis and three other preventive chemotherapy neglected tropical diseases in four sub-Saharan countries, as well as developing, training and evaluating the impact and performance of these programmes via national research institutions. She has field experience in The Gambia, Ivory Coast, Democratic Republic of Congo, Madagascar, Burundi and Kenya.</p>\n<p>\n <strong>8. Stefano Ongarello, PhD</strong></p>\n<p>\n Dr. Stefano Ongarello is the head of data services and biobanking at the Foundation for Innovative New Diagnostics <u>(</u>FIND), Switzerland. He is experienced statistical data scientist with 11 years in industry (pharmaceuticals & healthcare) and NGOs, leader of a multidisciplinary data management and data analysis team. he has strong expertise in statistical analysis, machine learning, pattern recognition and graphical representation of high dimensional data. Dr. Ongarello has many publications in peer-reviewed scientific journals. </p>\n<p>\n <strong>9. Joseph M Ndung’u, PhD</strong></p>\n<p>\n Prof. Joseph M Ndung’u is the head of NTD programme at the Foundation for Innovative New Diagnostics <u>(</u>FIND), Switzerland. He is also the current Chancellor of Jomo Kenyatta University of Agriculture and Technology (JKUAT), and Head of FIND DX office in Kenya. He has professional training as a veterinarian with a PhD in immunopathology of human African trypanosomiasis (HAT, or sleeping sickness). He is a visiting Professor, University of Glasgow, and a Corresponding Fellow of the Royal Society of Edinburgh (CorrFRSE). Prior to joining FIND in 2006, he was the Director of the Kenya Trypanosomiasis Research Institute (KETRI). He has extensive experience in development and introduction of diagnostics for HAT, leishmaniasis, Chagas disease, Buruli ulcer and recently in schistosomiasis. Prof. Ndung'u has published many articles in peer-reviewed scientific journals. </p>\n
      • other_details_explanation<p>\n The study cannot be conducted in the sponsor's host country (i.e. Switzerland) because schistosomiasis is not endemic. </p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<div>\n Pan African Clinical Trial Registry (www.pactr.org), 16 September 2020, PACTR202009780096688.</div>\n<div>\n  </div>\n<div>\n One site </div>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationFive months, from 1 October 2020 to 28 February 2021
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKenya Medical Research Institute (KEMRI)
      • single_site_physical_addressMbagathi Road
      • single_site_contact_personSammy Njenga
      • single_site_telephone+254 173372
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site776
      • total_participants_worldwide776
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
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      • gender_female1
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      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSultani
      • investigator1_middle_name
      • investigator1_family_nameMatendechero
      • investigator1_qualificationMPharm
      • investigator1_professional_addressMinistry of Health, Division of Vector Borne and Neglected Tropical Diseases
      • investigator1_telephone+254 722 65 24 91
      • investigator1_emailhadleysultani@gmail.com
      • organisations_transferred_Yes
      • number_participants776
      • notification
      • approval_date01-12-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-11-2020
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      • modified2022-03-21 16:07:17
      • created2020-09-24 06:04:28
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id593
        • application_id944
        • given_nameSammy
        • middle_name
        • family_nameNjenga
        • qualificationPhD
        • professional_addressKenya Medical Research Institute (KEMRI)
        • telephone+254 735 173372
        • emailsammynjenga@gmail.com
        • created2020-09-24 07:49:14
        • modified2020-11-18 16:31:47
    • SiteDetail(array)
      • 0(array)
        • id816
        • application_id944
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        • created2020-09-24 07:49:14
        • modified2020-11-18 16:31:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id457
        • application_id944
        • sponsorFoundation for Innovative New Diagnostics (FIND)
        • sponsor_typeOthers
        • contact_personSarah Nogaro
        • addressCampus Biotech, Geneva, Switzerland
        • telephone_number+41 22 710 05 90
        • fax_number
        • cell_number+41 22 710 05 90
        • email_addressSarah.Nogaro@finddx.org
        • created2020-09-24 07:49:14
        • modified2020-11-18 16:31:47
  • 4(array)
    • Application(array)
      • id889
      • user_id336
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Introduction</strong>: Post-partum hemorrhage (PPH) is one of the leading causes of maternal mortality in Kenya and contributes to approximately one-third of all maternal deaths [1, 2]. Considerable effort and more catalytic investments are required for Kenya to achieve the SDG goal of only 70 deaths per 100,000 live births by 2030 [3].  In 2012, the WHO began recommending the uterine balloon tamponade (UBT) for PPH management when uterotonic drugs failed or were not available [4]. The UBT is a non-surgical approach to treating PPH. Commercially available, quality-assured UBTs that have received regulatory approval, are prohibitively expensive for low- and middle-income countries (LMICs). To fill this gap, PATH (Seattle, USA) in collaboration with Sinapi Biomedical (Stellenbosch, South Africa) designed the Ellavi UBT, a preassembled, low-cost, effective, free-flow, pressure-controlled system that allows the uterus to contract. The Ellavi UBT received regulatory approval from the Kenyan Pharmaceutical and Poison Board in October 2019. </p>\n<p>\n <strong>Objectives</strong>: We aim to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within <strong>Kenyan</strong> PPH management programs for both public and private sector programs. Specifically, we will: 1) determine the adoption, penetration, sustainability and fidelity of integrating the Ellavi UBT device into PPH programs; 2) determine the appropriateness, acceptability and feasibility of using the Ellavi UBT by exploring user comprehension, accuracy of use, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness; 3) determine the cost of introducing the Ellavi UBT into the PPH management protocols; and 4) disseminate the findings nationally and internationally to support information sharing, increased awareness of the role of the UBT for refractory PPH, and adoption of its use.</p>\n<p>\n <strong>Methods</strong>: We will collect data at three health facilities (Kenyatta National Hospital, Mbagathi Hospital, St. Mary’s Medical Mission) over a period of six months starting in September 2020. To determine adoption, penetration, sustainability, and fidelity we will collect hospital level data on training rates, facility adoption of Ellavi UBT, provider usage, fidelity to training, and sustained correct usage.  To determine appropriateness, acceptability and feasibility we will: 1) survey all obstetrical care workers (up to 200) following a training course on PPH and Ellavi UBT use to solicit feedback for improvement on course components (lecture, virtual webinar, and simulation modeling); 2) obtain feedback on the Ellavi UBT device by surveying up to 100 health care providers post-usage; 3) obtain secondary data from hospital registries on the number of births, PPH events, refractory PPH cases, uses of condom catheters, and uses of Ellavi UBT devices.  To estimate costs we will identify: 1) the costs of training, 2) the costs of country level activities associated with integration of the Ellavi UBT into the PPH management protocols (i.e. meetings, advocacy, communication materials), and 3) the cost of procuring the Ellavi UBT in comparison to the cost of condom catheters (direct costs, stock-out issues, time spent towards assembly). To disseminate our study findings, PATH and UofN will organize a regional meeting with key stakeholders and present at international conferences.</p>\n<p>\n <strong>Utility:</strong> We aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. Our purpose is to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.</p>\n
      • study_title<p align=\"center\">\n <strong>An investigation into the barriers and facilitators of scaling up the innovative, low-cost Ellavi Uterine Balloon Tamponade for postpartum hemorrhage in Kenya</strong></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Post-partum hemorrhage (PPH) is one of the leading causes of maternal mortality in Kenya and contributes to approximately one-third of all maternal deaths [1, 2]. Considerable effort and more catalytic investments are required for Kenya to achieve the SDG goal of only 70 deaths per 100,000 live births by 2030 [3].  </p>\n<p>\n In 2012, the WHO began recommending the uterine balloon tamponade (UBT) for PPH management when uterotonic drugs failed or were not available [4]. The UBT is a non-surgical approach to treating PPH. Commercially available, quality-assured UBTs that have received regulatory approval, are prohibitively expensive for low- and middle-income countries (LMICs). To fill this gap, some health care workers in LMICs improvise condom catheters at the point of care by gathering and assembling the essential materials at the time a woman is experiencing uncontrolled PPH. This scenario is not optimal as it adds time and pressure on the provider. Additionally, condom catheters are not regulatory-approved medical devices, thus quality control and integration into supply chains is problematic. In response to this gap, PATH (Seattle, USA) in collaboration with Sinapi Biomedical (Stellenbosch, South Africa) designed the Ellavi UBT, a preassembled, effective, and low-cost device. The Ellavi UBT fills the gap between the expensive devices and the condom catheter balloon kits as it is an inexpensive (<$15), free-flow, pressure-controlled system that allows the uterus to contract. The Ellavi UBT received regulatory approval from the Kenyan Pharmaceutical and Poison Board in October 2019. </p>\n<p>\n This implementation research study will generate evidence to inform the successful uptake and adoption of the Ellavi UBT within <strong>Kenyan</strong> PPH management programs. We aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. Our purpose is to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.</p>\n
      • short_titleTHE ELLAVI UBT STUDY
      • protocol_noECCT/20/09/05
      • version_no6.0
      • date_of_protocol09-07-2020
      • study_drugN/A
      • disease_conditionPost partum haemorrhage
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameEllavi Uterine Balloon Tamponade device
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresszahida@qureshi.co.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantProf. Zahida Qureshi
      • declaration_date122-09-2020
      • declaration_principal_investigatorProf. Zahida Qureshi, Principal investigator
      • declaration_date222-09-2020
      • placebo_presentNo
      • study_objectives<p>\n The purpose of this implementation research study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within <strong>Kenyan</strong> MOH PPH management programs for both public and private sector programs. We aim to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.</p>\n<p>\n <strong>Specific objectives:</strong></p>\n<p>\n 1.    To determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT device into PPH care in three health care facilities (2 public facilities, 1 private facility). We will explore the number of health workers and facilities that receive the PPH and Ellavi UBT training, and percent of health workers and facilities that adopt the Ellavi UBT device over the 6-month period. We will also assess factors that influence the adoption, penetration, sustainability, and fidelity through an operations research survey, and the Ellavi UBT questionnaire.</p>\n<p>\n 2.    To determine the appropriateness, acceptability and feasibility of using the Ellavi UBT in participating health facilities at various levels of care in Nairobi County, we will explore user comprehension of the Ellavi UBT usage steps, accuracy of use, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.  </p>\n<p style=\"margin-left:56.25pt;\">\n a.    Sensitize senior management at each of the three participating facilities, separately.</p>\n<p style=\"margin-left:56.15pt;\">\n b.    Conduct two half-day trainings on PPH and Ellavi UBT use at each of the three participating health facilities separated by: 1) obstetricians, medical and clinical officers, and 2) midwives. </p>\n<p style=\"margin-left:56.15pt;\">\n c.     Collect individual initial (post-training) data to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, and insights into training effectiveness.</p>\n<p style=\"margin-left:56.15pt;\">\n d.    Case Management Form (CMF): Obstetrical care provider will complete a CMF within 24hrs (<24hrs) of managing each PPH event. This will inform the study team of how decision-making algorithms were applied and accuracy of use.</p>\n<p style=\"margin-left:56.15pt;\">\n e.    Ellavi UBT Questionnaire: PATH-Kenya study team member will collect individual post (post-usage) Ellavi UBT use data (<72hrs) from each study participant (obstetrical care worker) to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.</p>\n<p style=\"margin-left:56.15pt;\">\n f.      Study staff will record secondary data from hospital registry books over the six (6) month duration of this study (September 2020 – February 2021) in comparison to the same six (6) month period in 2019/2020 to examine changes in use of condom catheters, and Ellavi UBTs.  </p>\n<p style=\"margin-left:56.25pt;\">\n g.    Use the Consolidated Framework for Implementation Research (CFIR) to identify constructs with the potential to influence the introduction and use of Ellavi UBT. These constructs will be mapped to questions in the questionnaire, and will be analyzed to identify their influence on Ellavi UBT use. Constructs that have influence on the implementation of UBTs (both positively and negatively) will be disseminated for use in future introduction and scale up of Ellavi UBTs.</p>\n<p>\n 3.    To determine the cost of introducing the Ellavi UBT into the PPH management protocol and health system. </p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Estimate the costs of the different obstetrical care provider training components.   </li>\n <li>\n Estimate the costs for other country-level activities associated with the introduction of the UBT into the PPH management protocols such as costs for meetings, advocacy, and communication materials.</li>\n <li>\n Qualitatively evaluate the frequency and duration of stock outs of condoms, catheters, IV fluids (sterilized materials), and sutures.</li>\n <li>\n Estimate the costs of staff time spent on assembling a condom catheter UBT and the costs of supplies used.</li>\n</ol>\n<p>\n 4. To disseminate the information in national (KOGS), regional (ECSACOG, AFOG), and international forums to support information sharing, increased awareness of the role of UBT for refractory PPH, and adoption of its use.</p>\n<p style=\"margin-left:72.0pt;\">\n a.    Summarize how the Ellavi UBT can be integrated into curriculums, guidelines, and hospital systems (e.g. patient-provider friendly materials) by analyzing the key facilitators and barriers. </p>\n<p style=\"margin-left:72.0pt;\">\n b.    Host a national level meeting with Kenyan MOH stakeholders and participating facilities</p>\n<p style=\"margin-left:72.0pt;\">\n c.     Publish and disseminate findings in a peer-reviewed journal</p>\n<p style=\"margin-left:72.0pt;\">\n d. Present at international conferences and forums, as funding permits. Show the use of Ellavi UBT using poster presentations and demonstration sessions at international obstetrics meetings: FIGO, WHO UBT group, Women Deliver as funding permits.</p>\n
      • principal_inclusion_criteria<p>\n Study participants will include all obstetricians, medical officers, clinical officers, and midwives who have recently participated in a PPH/Ellavi UBT training or managed a refractory PPH case with or without the use of an Ellavi UBT (within the past 72 hours) at one of the three participating health care facilities.</p>\n<p>\n While our preference is to interview health care workers post PPH management that had participated in one of the Ellavi UBT trainings, if they missed the training (and used or did not use an Ellavi UBT) then this would inform us about the feasibility of rolling out the Ellavi UBT without consistent trainings.</p>\n<p>\n All PPH cases will be included, only de-identified secondary patient data will be used. This data will set the context for the use of the Ellavi UBT device.</p>\n<p>\n Obstetric care workers will be asked to estimate staff time spent on assembling a condom catheter UBT and the costs of supplies used.</p>\n<p>\n Hospital administrators, supply store managers and/or procurement staff will be interviewed to obtain information on frequency and duration of stock outs of male condoms, catheters, catheter plugs, syringe, IV fluids (sterilized materials), string, and sutures.</p>\n
      • principal_exclusion_criteria<p>\n Obstetricians, medical officers, clinical officers, and midwives working at the facility who do not agree or consent to participate.</p>\n
      • primary_end_points<p>\n <strong>Primary outcomes:</strong>1) adoption, penetration, sustainability, and fidelity; and 2) appropriateness, acceptability, and feasibility by measuring context of use, accuracy of use, perceptions of the device, user confidence, acceptability, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.</p>\n<p>\n Se<strong>condary outcomes</strong> will include financial data to determine the cost of introducing the Ellavi UBT into the Kenyan PPH management protocols and the health system.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability, usability, and feasibility study
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyAcceptability, usability and feasibility study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The facilities:</p>\n<ol>\n <li>\n Kenyatta National Hospital:</li>\n</ol>\n<p>\n  </p>\n<p>\n Kenyatta National Hospital (KNH) is a public, level 6, referral hospital for the Ministry of Health. This facility is the largest hospital in the country and is located in central Nairobi. KNH offers both general and specialized care (cancer treatment, cardiology, colposcopy, diabetes, dental, ENT, Eye, diabetes, family planning, neurology, obstetrics & gynecology, occupational therapy, orthopedic, physiotherapy, rheumatology, surgical outpatient clinic, pediatric outpatient clinic, tuberculosis). </p>\n<p>\n  </p>\n<p>\n KNH provides 24-hour obstetric care and assists over 12,000 deliveries and 500 PPH cases each year. This facility serves as the teaching hospital for the University of Nairobi College of Health Sciences. The current training methods used for PPH at KNH include advanced life support in obstetrics (ALSO), emergency obstetrics and neonatal care (EMONC), presentations, and simulation drills. The labor ward is staffed by two (2) senior health officers and one (1) consultant/obstetrician at all times and 12 midwives during the day and 16 midwives during the night shift regardless of weekday or weekend. The maternity wing at KNH includes 3 antenatal wards (with two rooms), 3 postnatal wards (with 3 rooms), two operating theatres, a labor ward (8 rooms for 1^st stage of labor, 2 delivery rooms, acute room for sick patients, 1 observation room for 4^th stage).  </p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<ol>\n <li value=\"2\">\n Mbagathi District Hospital</li>\n</ol>\n<p style=\"margin-left:.5in;\">\n Mbagathi District Hospital is a public level 4 hospital for the Ministry of Health. It is one of Nairobi’s busiest hospitals, located on the edge of Kibera (Africa’s largest urban slum). Mbagathi assists with almost 7,000 deliveries each year, providing care for approximately 40 PPH events (including local PPH referrals), of which one-third require invasive surgery (e.g. hysterectomy, B-lynch sutures). The labor ward is staffed by one (1) consultant (obstetrician), one (1) medical officer, three (3) midwives, and three (3) medical interns during the weekdays, weeknights, and weekends.</p>\n<ol>\n <li value=\"3\">\n St. Mary’s Mission Hospital:</li>\n</ol>\n<p style=\"margin-left:.5in;\">\n St. Mary’s Mission Hospital (SMMH) is a private, level 5, hospital located in Lang’ata, Nairobi with over 300 inpatient beds. SMMH offers a variety of services for outpatients (General Care, Dental Services, Pharmacy Services, Laboratory Services, Imaging Services, HIV/AIDS Prevention Treatment and Care, Maternal and Child Health, Eye Services, Nutrition Services) as well as inpatients (Medical ward/Surgical ward, Maternity Ward, Post Natal Ward, New Born Unit, Pediatric Ward, Operating Theatre, Inpatient gynecology consultation, Physiotherapy, Chaplaincy Services).</p>\n<p style=\"margin-left:.5in;\">\n In the maternity ward, midwives are responsible for the majority of vaginal deliveries while obstetricians are focused on surgical obstetric care (e.g. Cesarean section). This facility assists over 4000 deliveries and approximately 40 PPH events per year (3-6 PPH events/month; 0 PPH referrals). Only a small fraction of the PPH events require invasive surgeries (e.g. hysterectomy, B-lynch sutures) which can be handled by the on-staff obstetricians. Typically, the labor ward is staffed with two (2) doctors, one (1) nurse, eight (8) midwives, and three (3) support staff. During both the weekdays, weeknights, and weekends, one (1) doctor and four (4) midwives are present to tend to the labor ward. In 2019, 14 staff members at SMMH received PPH training. </p>\n
      • other_details_explanation<p>\n This implementation research study will generate evidence to inform the successful uptake and adoption of the Ellavi UBT within <strong>Kenyan</strong> PPH management programs. We aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. Our purpose is to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n PATH REC (Research Ethics Committee). 8 June 2020, 3 sites - KENYA</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationThe total duration from conception of the research idea to approvals, data collection, and analysis is 3 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteKNH: 110; Mbagathi: 68; St. Mary’s: 22
      • total_participants_worldwideN/A
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMegan
      • investigator1_middle_nameE
      • investigator1_family_nameParker
      • investigator1_qualificationSenior Nutrition Research Officer Maternal Newborn Child Health and Nutrition
      • investigator1_professional_addressPATH, 2201 Westlake Ave, Suite 200 Seattle, WA 98121 USA
      • investigator1_telephoneWork: +1.206.302.4694 Mobile: +1.202.460.6239
      • investigator1_emailmparker@path.org
      • organisations_transferred_No
      • number_participants200 Health care workers
      • notification
      • approval_date02-12-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-10-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved by the expert committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-06-24 13:04:06
      • created2020-05-13 10:43:38
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id548
        • application_id889
        • given_nameZahida
        • middle_nameP
        • family_nameQureshi
        • qualificationAssociate Professor
        • professional_addressDepartment of Obstetrics and Gynaecology School of Medicine College of Health Sciences University of Nairobi P.O. Box 19676-00202 Nairobi, Kenya
        • telephoneWork: 2726300 Ext. 43372 or 2726360 Mobile: 0733605140 or 0721310750
        • emailqureshi@uonbi.ac.ke
        • created2020-05-13 10:50:33
        • modified2020-10-19 18:42:06
      • 1(array)
        • id549
        • application_id889
        • given_nameOmondi
        • middle_name
        • family_nameOgutu
        • qualificationAssociate Professor
        • professional_addressDepartment of Obstetrics and Gynaecology School of Medicine College of Health Sciences University of Nairobi P.O. Box 19676-00202 Nairobi, Kenya
        • telephone0722510215
        • emailoomogutu@gmail.com
        • created2020-05-13 11:15:42
        • modified2020-10-19 18:42:06
      • 2(array)
        • id550
        • application_id889
        • given_nameAlfred
        • middle_nameOnyango
        • family_nameOsoti
        • qualificationSenior Lecturer
        • professional_addressDepartment of Obstetrics and Gynaecology School of Medicine College of Health Sciences University of Nairobi P.O. Box 19676-00202 Nairobi, Kenya
        • telephone0733886664
        • emailalfosoti@gmail.com
        • created2020-05-13 11:27:49
        • modified2020-10-19 18:42:06
      • 3(array)
        • id551
        • application_id889
        • given_nameGeorge
        • middle_nameNyakundi
        • family_nameGwako
        • qualificationLecturer
        • professional_addressDepartment of Obstetrics and Gynaecology School of Medicine College of Health Sciences University of Nairobi P.O. Box 19676-00202 Nairobi, Kenya
        • telephone0722992268
        • emailgngwako@gmail.com
        • created2020-05-13 11:27:49
        • modified2020-10-19 18:42:06
      • 4(array)
        • id552
        • application_id889
        • given_nameJames
        • middle_name
        • family_nameSoki
        • qualificationPATH Strategic Partnerships Fellow
        • professional_addressPATH Kenya Country Program
        • telephone0700586828
        • emailjsoki@path.org
        • created2020-05-13 11:32:06
        • modified2020-10-19 18:42:06
      • 5(array)
        • id553
        • application_id889
        • given_nameJames
        • middle_name
        • family_nameGitonga
        • qualificationProgram manager, Maternal and Newborn Health
        • professional_addressReproductive Maternal Health Services Unit Ministry of Health Kenya Nairobi, Kenya
        • telephone07222916765
        • emailgintongaj2003@yahoo.co.uk
        • created2020-05-13 11:32:06
        • modified2020-10-19 18:42:06
    • SiteDetail(array)
      • 0(array)
        • id770
        • application_id889
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressHospital road, Nairobi
        • contact_detailsP.O Box 20723-00202, Nairobi, Kenya Tel: 020-2726300 Mobile: 0709 85400/ 0730 643000 Email: knhadmin@knh.or.ke
        • contact_personProf. Zahida Qureshi
        • site_capacity(null)
        • misc(null)
        • created2020-05-13 10:50:33
        • modified2020-10-19 18:42:06
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id771
        • application_id889
        • county_id47
        • site_nameMbagathi Hospital
        • physical_addressMbagathi Road
        • contact_detailsP.O Box 20725 Nairobi, Kenya Tel: +254 20 2724712
        • contact_personDr. Joan Thathi
        • site_capacity(null)
        • misc(null)
        • created2020-05-13 11:49:42
        • modified2020-10-19 18:42:06
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id772
        • application_id889
        • county_id47
        • site_nameSt. Marys Mission Hospital
        • physical_addressKungu Karumba Road, Langata, Nairobi
        • contact_detailsP.O. Box 960-00517 Lang’ata, Nairobi, Kenya Tel: 02 0785 1300 Email: info@stmmh.co.ke
        • contact_personDr. Victoria Muviku
        • site_capacity(null)
        • misc(null)
        • created2020-05-13 11:49:42
        • modified2020-10-19 18:42:06
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id431
        • application_id889
        • sponsorPATH Seattle
        • sponsor_typeOthers
        • contact_personElizabeth Abu-Haydar
        • address2201 Westlake Avenue, Suite 200, Seattle, WA 98121 USA
        • telephone_number+12062853500
        • fax_number
        • cell_number+12063108874
        • email_addresseabuhaydar@path.org
        • created2020-05-13 10:50:33
        • modified2020-10-19 18:42:06
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php