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  • 1Recruiting
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    • Application(array)
      • id1127
      • user_id263
      • trial_status_id5
      • abstract_of_study<p>\n Sickle cell disease (SCD) is a related group of common and rare hemoglobin (Hb) genotypes in which all affected individuals are either homozygotes for the sickle Hb (HbS) mutation of the β-globin subunit or compound heterozygotes for HbS and another globin gene mutation. A hallmark symptom of SCD is a painful Vaso-occlusive crisis (VOC). An interplay of the various pathologic processes in SCD perpetuates and feeds forward an inflammatory priming that, in the presence of a precipitating event, can lead to a VOC. VOCs are responsible for a wide variety of clinical complications of SCD, including pain syndromes, acute chest syndrome (ACS), stroke, priapism, leg ulcers, spontaneous abortion, renal insufficiency, and multiorgan failure leading to death. Frequency of VOCs, along with Absolute Neutrophil count (ACS), is the most common predictor of death in patients with SCD. Thus, early identification, treatment, and prevention of VOCs could significantly impact the natural course of the disease. Interventions for treatment and prevention of longer-term complications are urgently needed.</p>\n<p>\n  </p>\n<p>\n About 240,000 children in Africa, are born each year with Sickle Cell Disease (SCD), while here in Kenya, it is estimated that 6,000 children are born with the disease. Sadly, between 50 to 80 per cent of these children die before their fifth birthday. The recurrent pain and complications caused by the disease, can interfere with many aspects of the patient’s life, including education, employment and psychosocial development.</p>\n
      • study_title<p align=\"center\">\n <strong>A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Characterize the Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients with Sickle Cell Disease</strong></p>\n
      • laymans_summary<p>\n The objective of this study is to understand/characterize the pharmacokinetic/PK (how our bodies affect the drug) and the Pharmacodynamics/PD (meaning how the drug affects our bodies) of a drug called Rifaximin, which is used in treatment of patients with sickle cell disease.</p>\n<p>\n Of the current treatment options available for sickle cell disease, only bone marrow transplant is a permanent cure, but few patients qualify for this treatment. Patients on the other treatment options e.g., hydroxyurea and L glutamine may still experience acute clogging of blood vessels called Vaso Occlusive crisis (VOC) There is a need to find more treatment options for sickle cell disease that prevents the VOC.</p>\n
      • short_titleSickle Cell Disease
      • protocol_noECCT/22/03/06
      • version_noVersion 2.0_16 Aug 2021
      • date_of_protocol16-08-2021
      • study_drugrifaximin ER and DER
      • disease_conditionSickle cell disease
      • 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_namexifaxan
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
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      • declaration_applicantMichelle Botha
      • declaration_date120-03-2022
      • declaration_principal_investigatorDr L Tina
      • declaration_date220-03-2022
      • placebo_presentYes
      • study_objectives<p>\n The objectives of this study are: To characterize the pharmacokinetics/pharmacodynamics (PK/PD) of rifaximin ER and DER in subjects with sickle cell disease (SCD) and to assess the safety and tolerability of rifaximin (Extended Release) ER and Delayed Extended Release (DER).</p>\n
      • principal_inclusion_criteria<p>\n Participants are eligible for the study only if all the following criteria are met:</p>\n<ol>\n <li>\n Subject must have the ability and willingness to sign a written informed consent form.</li>\n <li>\n Subject is between the ages of 18 to 70 years old (inclusive) at the time of consent.</li>\n <li>\n Subject has SCD of any genotype (HbSS, HbSC, HbS β-thalassemia). If the subject’s genotype has not been previously documented, genotyping will be performed during Screening using high-performance liquid chromatography (HPLC)/electrophoresis.</li>\n <li value=\"4\">\n Subject must have experienced at least 2 VOCs within the 12 months prior to Screening. A VOC is defined as: </li>\n</ol>\n<p>\n                             a. The occurrence of appropriate symptoms consistent with a painful crisis, acute chest syndrome (ACS), or priapism, and</p>\n<p style=\"margin-left: 72pt;\">\n b. Requires a visit to a medical facility and/or healthcare professional, and</p>\n<p style=\"margin-left: 72pt;\">\n c. Receipt of either a parenteral or oral opioid or NSAID analgesia.</p>\n<ol>\n <li value=\"5\">\n If subject is receiving hydroxyurea (HU)/hydroxycarbamide (HC), subject must have been receiving the treatment for at least 6 months prior to Screening and must agree to maintain the same dose and schedule for the duration of the study.</li>\n <li value=\"6\">\n Subjects must have laboratory values at Screening within the following ranges:\n <ul>\n <li>\n Absolute Neutrophil Count ≥1.0 x 109/L</li>\n <li>\n Platelets ≥ 75 x 109/L</li>\n <li>\n Hemoglobin (Hgb) ≥ 6.0 g/dL</li>\n <li>\n Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m2 using the CKD-EPI formula</li>\n <li>\n Direct (conjugated) bilirubin ≤ 2.0 x ULN</li>\n <li>\n Alanine transaminase (ALT) ≤ 3.0 x ULN</li>\n <li>\n International Normalized Ratio (INR) ≤ 2.0</li>\n </ul>\n </li>\n <li value=\"7\">\n Eastern Cooperate Oncology Group (ECOG) performance status ≤ 2.</li>\n <li value=\"8\">\n Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at Screening and agree to use standard prevention methods for the duration of the study.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Participants are not eligible for inclusion for the trial if any of the following criteria are met:</p>\n<ol>\n <li>\n Subject is receiving concomitant treatment with voxelotor, crizanlizumab, or L-glutamine.</li>\n <li>\n Subject has any history of stem cell transplant is planning to begin or has received in the past 30 days.</li>\n <li value=\"3\">\n Subject experiences an acute VOC, requiring a visit to a medical facility and/or healthcare professional, ending within 7 days prior to Day 1 dosing.</li>\n <li value=\"4\">\n Subject has received any blood products within 30 days of Day 1 dosing.</li>\n <li value=\"5\">\n Subject has uncontrolled liver disease or renal impairment, ulcerative colitis, Crohn’s disease, or other chronic GI disorder.</li>\n <li value=\"6\">\n Subject has received active treatment in another investigational trial within 30 days or 5 half-lives of the last dose of the investigational agent, whichever is greater, prior to Screening.</li>\n <li value=\"7\">\n Subject has received penicillin prophylaxis or antibiotics for treatment of infection within 30 days or 5 half-lives of the treatment, whichever is greater, prior to Screening.</li>\n <li value=\"8\">\n Subject has a significant medical condition that required hospitalization (other than for a VOC) within 2 months prior to Screening.</li>\n <li value=\"9\">\n Subject is planning on undergoing an exchange transfusion during the duration of the study or has completed one within 4 weeks prior to Day 1 dosing.</li>\n <li value=\"10\">\n Subject has a hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any components of rifaximin ER and DER.</li>\n <li value=\"11\">\n Subject has used therapeutic anticoagulation (prophylactic doses are permitted) or antiplatelet therapy (other than aspirin or NSAIDs) within 10 days prior to Day 1 dosing.</li>\n <li value=\"12\">\n Subject is pregnant or a nursing woman.</li>\n <li value=\"13\">\n Subject has a history of illicit drug use or abuse, either documented or in the opinion of the Investigator.</li>\n <li value=\"14\">\n Subject is using any medication that is known to inhibit or induce CYP3A4, P-gp, or OATP1B1/B3 (See Appendix 3) within 30 days or 5 half-lives, whichever is longer, prior to Day 1 dosing, or in the opinion of the Investigator, may affect the evaluation of the study product or place the subject at undue risk.</li>\n <li value=\"15\">\n Subject has had any prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach, or small/large intestine (with the exception of appendectomy, cholecystectomy, and fundoplication).</li>\n <li value=\"16\">\n Subject has had a colonoscopy or sigmoidoscopy within 30 days prior to Day 1 or plans to undergo such a procedure during the duration of the study.</li>\n <li value=\"17\">\n Subject has used bowel prep, laxative, or enema within 30 days prior to Day 1.</li>\n <li value=\"18\">\n Subject has a bleeding disorder including, but not limited to, acquired or congenital platelet function defects, disseminated intravascular coagulation (DIC), bleeding factor deficiencies, hemophilia, idiopathic thrombocytopenia purpura (ITP), or von Willebrand’s disease.</li>\n <li value=\"19\">\n Subject is planning to undergo a major surgical procedure during the duration of the study.</li>\n <li value=\"20\">\n Subject has a positive test for human immunodeficiency virus (HIV)1 or HIV2.</li>\n <li value=\"21\">\n Subject has an active Hepatitis B infection (HBsAg positive). Prior infection that is not active (i.e., HBsAg negative, HBcAb positive, and HBsAb positive) is permitted.</li>\n <li value=\"22\">\n Subject has a positive test for Hepatitis C (HCV RNA). Prior infection with spontaneous resolution or sustained resolution for ≥ 24 weeks after cessation of antivirals is permitted.</li>\n <li value=\"23\">\n Subject has an active COVID-19 infection or complication(s) related to COVID-19 infection that are unresolved or, in the opinion of the Investigator, may affect evaluation of the study drug or place the subject at undue risk.</li>\n <li value=\"24\">\n Subjects has received a vaccine (including COVID-19 vaccine) within 2 weeks prior to Screening. If subject has received their first of two COVID-19 vaccination doses, as applicable, they must wait for at least 2 weeks after receiving the second dose, and be symptom-free, prior to beginning Screening. Subject must not be planning for COVID-19 or other vaccinations while on study.</li>\n <li value=\"25\">\n Subject has a malignant disease. Exceptions include malignancies that were treated curatively and have not recurred within 2 years prior to study treatment, completely resected basal cell and squamous cell skin cancers, and any completely resected carcinoma in situ.</li>\n <li value=\"26\">\n Subjects has prolonged QT interval as assessed by ECG history within the past 3 months. For subjects with no historical ECG information, subject has a resting QTcF ≥ 460 msec for males and ≥ 470 msec for females at Screening.</li>\n <li value=\"27\">\n Subject has any unstable cardiac condition that, in the opinion of the Investigator, may worsen during the study or interfere with successful evaluation of the study treatment.</li>\n <li value=\"28\">\n Subject has a serious mental or physical illness which, in the opinion of the Investigator, would compromise participation in the study.</li>\n <li value=\"29\">\n Subject has any condition which, in the opinion of the Investigator, is likely to interfere with the successful collection of the measurements required for the study.</li>\n</ol>\n
      • primary_end_points<p>\n Full rifaximin and 25-desacetyl rifaximin plasma PK profiles following administration on Days 1 and 29 and C_max and C_trough on Days 8, 15, and 29 will be evaluated at specified timepoints according to the schedule of activities.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 1. Victoria Biomedical Research Institute (VIBRI) (PI:  LO Tina):</p>\n<p>\n VIBRI is a non-profit providing pharmaceutical, academic research and non-profit organization with a network of clinical sites and expertise focusing on accelerating transformative therapeutics, vaccines, and devices research for major gloabl health diseases in Kenya.  VIBRI is located at the Kisumu County Referral Hospital in Kisumu County, western Kenya.  VIBRI was established to conduct biomedical research including clinical trials, bioequivalence studies, basic science research studies, epidemiology and population health studies, implementation science studies, build a strong doundation in data science, conduct training and capacity building on clinical research in Kenya.  VIBRI has experienced and accomplished clinical research scientists who have designed and conducted GCP compliance phase 1b to phase IV paediatric and adult clinical trials.  </p>\n<p>\n 2. CREATES (PI:  Dr Bernhards Ogutu):</p>\n<p>\n The KUTRH is designed for clinical trials with a bed space of 600 and ICU beds of 25.  It is a referral healthcare facility experienced in clinical trials. The PI is support by a large team of experienced Sub Investigators and SSCs.  Along with experienced pharmacists to manage the IP.  The site has ample well-equipped clinical laboratories, radiological services and ample clinical observation areas as well as spacious research operations office.</p>\n<p>\n 3. International Cancer Institute (PI:  Prof. FC Asirwa):</p>\n<p align=\"left\" style=\"margin-left:.45pt;\">\n The study will be conducted at the International Cancer Institute (ICI) in Eldoret, Kenya. Recruitment will occur at the research and care clinic located along Nandi Road. ICI research and care clinic is staffed by qualified research personnel including 1 Medical Oncologist, 1 Clinical Oncologist, 4 medical officers, 1 Pharmacist, 1 pharmaceutical Technologist, 1 clinical officer, 4 nurses,1 consultant pathologist, 2 laboratory technologists, 1 patient navigator and 1 administrator. ICI has a research and molecular diagnostics laboratory, for sample testing and storage. The site has a registration area, consultation rooms, examination rooms, chemotherapy administration area, records and data storage, pharmacy and laboratory. International Cancer Institute currently runs a clinic where patients with SCD from Uasin Gishu County and different parts of the Country are managed. The site participates in several other Randomized controlled trials with key focus on Haemato-oncology trials.</p>\n<p>\n 4. KEMRI/USAMRD-K Kombewa Clinical Research Center (PI: Janet Oyieko)</p>\n<div>\n The KEMRI/WRP Kombewa Clinical Research Center (KCRC) is designed for large clinical</div>\n<div>\n trials and has a full clinical laboratory including microbiology capability.</div>\n<div>\n KCRC is part of The Walter Reed Project (WRP), which is a 40-year collaboration between the</div>\n<div>\n Kenya Medical Research Institute, (KEMRI) and the Walter Reed Army Institute of Research</div>\n<div>\n (WRAIR). The US Army Medical Research Unit in Kenya (USAMRU-K) is a WRAIR</div>\n<div>\n attachment stationed in Kenya with headquarters in Nairobi and field stations in Kericho and</div>\n<div>\n Kisumu. WRP-Kisumu conducts a wide spectrum of field and laboratory work including</div>\n<div>\n numerous clinical research trials.</div>\n
      • other_details_explanation<p>\n Study is being conducted in America</p>\n
      • other_details_regulatory_notapproved<p>\n Applications are planned for Egypt and Lebanon</p>\n
      • other_details_regulatory_approved<p>\n US FDA provided approval to proceed on 11 June 2021</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration6 months
      • 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
      • 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_states2
      • number_of_sites4
      • multi_country_listNorth America\nMiddle east
      • data_monitoring_committeeNo
      • total_enrolment_per_site3-10
      • total_participants_worldwide60
      • 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_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_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationMBChB, MSc, DLSHTM
      • investigator1_professional_addressVictoria Biomedical Research Institute
      • investigator1_telephone+254720596654
      • investigator1_emaillucas.tina0818@gamil.com
      • organisations_transferred_Yes
      • number_participants20
      • notification
      • approval_date15-09-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-05-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
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      • quantity_destroyed(null)
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      • balance_site(null)
      • final_date(null)
      • modified2024-06-11 12:33:58
      • created2022-03-09 10:16:30
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id799
        • application_id1127
        • given_nameJanet
        • middle_name
        • family_nameOyieko
        • qualificationMBChB, MMED, PhD
        • professional_addressKombewa Clinical Research Centre
        • telephone+254721996988
        • emailjanet.oyieko@gmail.com
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
      • 1(array)
        • id800
        • application_id1127
        • given_nameFredrick
        • middle_nameChite
        • family_nameAsirwa
        • qualificationProf, M.D.
        • professional_addressInternational Cancer Institute (ICI).
        • telephone+254 718 473 446
        • emaildirector@intercancer.com
        • created2022-03-11 10:09:31
        • modified2022-05-09 16:38:41
      • 2(array)
        • id801
        • application_id1127
        • given_nameBernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MSc
        • professional_addressCREATES - Strathmore University Medical Centre
        • telephone+254733812613
        • emailogutu6@gmail.com
        • created2022-03-11 10:09:31
        • modified2022-05-09 16:38:41
    • SiteDetail(array)
      • 0(array)
        • id1253
        • application_id1127
        • county_id42
        • site_nameKombewa Clinical Research Centre
        • physical_addressOff Kisumu-Bondo Road, opposite Kombewa county Hospital
        • contact_details+254721996988
        • contact_personDr. Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1254
        • application_id1127
        • county_id42
        • site_nameVictoria Biomedical Research institute
        • physical_addressP.O BOX 7180-40100 KISUMU
        • contact_details+254720597654
        • contact_personDr. Lucas Otieno tina
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1255
        • application_id1127
        • county_id27
        • site_nameInternational Cancer Centre
        • physical_addressNandi road, P.O BOX 8088, Eldoret
        • contact_details+254700522149
        • contact_personDr. Fredrick Asirwa
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id1256
        • application_id1127
        • county_id47
        • site_nameCREATES - Strathmore University Medical Centre
        • physical_addressP.O BOX 59857 - 00200 Madaraka Estate, Nairobi
        • contact_details+254733812613
        • contact_personDr. Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id583
        • application_id1127
        • sponsorSalix Pharmaceuticals, Inc., a division of Bausch Health US, LLC.
        • sponsor_typeIndustry
        • contact_person
        • addressBausch Health US, LLC Bridgewater, NJ 08807 USA
        • telephone_number1-800-321-4576
        • fax_number
        • cell_number 908-927-1400
        • email_addressSean.Humphrey@bauschhealth.com
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
  • 1(array)
    • Application(array)
      • id854
      • user_id606
      • trial_status_id7
      • abstract_of_study<p>\n Background:  Vincristine is among the most widely used and potentially effective chemotherapeutic agents in pediatric oncology patients. However, in black African children it is often sub optimally dosed due to genetic differences in the metabolism of vincristine. This study aims to optimize the dosing regimen of vincristine using therapeutic drug monitoring while carefully monitoring toxicity.</p>\n<p>\n Design This will be a prospective cohort study. All children aged 2-14 years diagnosed with cancer and scheduled to receive vincristine can be included. After the administration of vincristine, blood samples will be taken. These will be shipped to and analyzed in the Netherlands to determine the vincristine concentration in each sample. Based on this, a dose advise will be given for subsequent vincristine administrations. This cycle will be repeated in total 3 times. Toxicity will be monitored by determination of the bilirubin, by questionnaires and by physical examination to check for signs of peripheral neuropathy. </p>\n<p>\n Results We aim to include 100 patients. The required dose to achieve a therapeutic vincristine level, will be compared to a historic cohort. The results will lead to an alteration in the dosing regimen of vincristine in all pediatric oncology patients in Kenya. </p>\n
      • study_title<p>\n CHildren treated with vincristine: A trial regarding Pharmacokinetics, DNA And Toxicity of targeted therapy In pediatric oncology patients.</p>\n
      • laymans_summary<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">The aim of the study is to optimize treatment and improve survival for children on treatment for cancer by maximizing the use of Vincristine, a drug which is used in treatment of childhood cancer.</span></span></p>\n<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">Baseline assessment to check presence of nerve injury, bilirubin levels and malnutrition will be done before 1st administration of regular Vincristine dose. Blood sample will be obtained by a finger prick for analysis of Vincristine concentration after the dose has been given. The dose of Vincristine will  be increased during the next administration when the Vincristine concentration below the level calculated as safe and in the absence of severe vincristine induced peripheral neuropathy or any other severe side effect. A second, third and fourth dose adaptation will be given if the above criteria is met after each dose adaptation. </span></span></p>\n<p class=\"yiv4801908789\">\n <span style=\"font-size:12px;\"><span style=\"color: rgb(29, 34, 40);\">The information from this study might lead to a change in treatment of a wide range of cancers for black African children worldwide, by demonstrating that these children benefit from higher doses of VCR without severely increasing Vincristine induced peripheral neuropathy</span></span>.</p>\n<style type=\"text/css\">\n</style>\n
      • short_titleCHAPATI
      • protocol_noECCT/22/03/05
      • version_no01/2020
      • date_of_protocol05-12-2019
      • study_drugVincristine
      • disease_conditionAcute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Rhabdomyosarcoma, Neuroblastoma, Nephroblastoma, Retinoblastoma
      • 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_nameVincristine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskugolinet@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_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_applicantSandra Langat
      • declaration_date117-03-2022
      • declaration_principal_investigatorDr. Festus Muigai Njuguna
      • declaration_date217-03-2022
      • placebo_presentNo
      • study_objectives<p>\n 1. To determine the optimal vincristine dose among children receiving chemotherapy at MTRH </p>\n<p>\n 2. To evaluate the development and severity of peripheral neuropathy and liver toxicity in paediatric oncology patients receiving  optimized vincristine doses in MTRH</p>\n<p>\n 3. To study genetic variants that are associated with vincristine metabolism as well as the  development and severity of peripheral neuropathy </p>\n
      • principal_inclusion_criteria<p>\n 1. Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: children who are treated for acute lymphoblastic leukemia, children who are treated for non-Hodgkin's lymphoma, children who are treated for rhabdomyosarcoma,  children who are treated for neuroblastoma, children who are treated for nephroblastoma and children who are treated for retinoblastoma</p>\n<p>\n 2.  Written informed consent </p>\n
      • principal_exclusion_criteria<p>\n  1. Severe malnutrition (Z score ≤2SD of weight for height)</p>\n<p>\n  2. Total bilirubin >3 times upper limit of normal</p>\n<p>\n  3. Pre-existent severe mental retardation e.g. Down syndrome </p>\n
      • primary_end_points<p>\n 1. Vincristine Induced Peripheral Neuropathy</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n We have 4 main staff members including a pediatrician, pharmacist, study coordinator and data assistant. The site facility is in a level six hospital, in a well equiped and aqequately staffed paediatric oncology ward.</p>\n<p>\n 1. Dr. Festus Njuguna - Pediatrician - Master of Medicine (Paediatrics) (2005-2008), Bachelor of Medicine and Bachelor Surgery (1994-2000). Has over ten years working experince as a paediatrician and 8 years as a researcher in the pediatric oncology field</p>\n<p>\n 2. Dr. Linet Kugo - Pharmacist - Master of Pharmacy (Epivigil) (2013-2015); Bachelor of Pharmacy (2004-2008); 4 years experience as an oncology pharmacist with over 10 years experince as a pharmacist.</p>\n<p>\n 3. Sandra Langat - Study Coordinator - Bsc. in Medical Microbiology (2004-2007), 11 years working experinece in data collection and research coordination.</p>\n<p>\n 4. Martha Kipngetich - Data Assistant - Diploma in Information Technology (2002-2003), BSc. in Information Technology (2014 - 2015), 10 years working experience in data management, IT administration and research.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration2 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_stateYes
      • location_of_areaMoi Teaching and Referral Hospital
      • single_site_physical_addressNandi Road, Eldoret, Kenya
      • single_site_contact_personDr. Festus Muigai Njuguna
      • single_site_telephone0721219761
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide100
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • 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_consentYes
      • subjects_specifyAll the study subjects will be below 18 years hence consent will be given by their parents or legal guardians on their behalf.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFESTUS
      • investigator1_middle_nameMUIGAI
      • investigator1_family_nameNJUGUNA
      • investigator1_qualificationPEDIATRICIAN
      • investigator1_professional_addressMOI UNIVERSITY SCHOOL OF MEDICINE
      • investigator1_telephone0721219761
      • investigator1_emailmuigaifes2000@yahoo.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date25-10-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-02-26 10:55:08
      • created2020-02-20 09:03:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id525
        • application_id854
        • given_nameFESTUS
        • middle_nameMUIGAI
        • family_nameNJUGUNA
        • qualificationPEDIATRICIAN
        • professional_addressMOI UNIVERSITY SCHOOL OF MEDICINE
        • telephone0721219761
        • emailmuigaifes2000@yahoo.com
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
    • SiteDetail(array)
      • 0(array)
        • id696
        • application_id854
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id412
        • application_id854
        • sponsorPrincess Maxima Paediatric Oncology Center
        • sponsor_typeResearch Institution
        • contact_personProf. Gertjan Kaspers
        • addressHeidelberglaan 25, 3584 CS Utrecht, Netherlands
        • telephone_number+31889728751
        • fax_number
        • cell_number+31625710324
        • email_addressG.J.L.Kaspers@prinsesmaximacentrum.nl
        • created2020-02-20 09:21:18
        • modified2022-03-18 11:29:10
  • 2(array)
    • Application(array)
      • id1125
      • user_id729
      • trial_status_id7
      • abstract_of_study<p>\n Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus that emerged in the human population in Wuhan City, Hubei Province, China in December 2019. As of Jan 2022, there are over 328 million SARS-CoV-2 case worldwide and over 5.54 million deaths as a result of infection with SARS-CoV-2 (COVID-19). According to WHO Situation Report on 17 January 2022, Africa has 7 million confirmed cases with over 160, 804 deaths. The COVID-19 pandemic has caused global suffering, mortality, and severe economic pressures. There is thus a continued urgent global need to develop effective and safe vaccines and drugs to make them available at scale and equitably across all countries including in Africa.</p>\n<p>\n Despite the rapid successes in vaccine development and issuance of WHO Emergency Use Listings (EUL), the WHO SAGE Interim Reports and FDA Emergency Use Authorization (EUA) for COVID-19 vaccine evaluations have reported limitations on safety and efficacy data in certain populations including children and adolescents, pregnant women, and immunocompromised individuals such as those with HIV/AIDS who are at higher risk of severe COVID-19 disease. Africa is especially vulnerable in this respect given the high prevalence of HIV/AIDS in countries such as Kenya where the prevalence is over 20% in some places.</p>\n<p>\n The risk of recurring new waves of COVID-19 cases caused by Variants of Concern (VOC) exacerbate global public health crisis. A weak immune response to either single or two doses of primary vaccination against SARS-CoV-2 has been observed in immunocompromised population. Emerging data from observational studies consistently show waning immunity to primary vaccination for SARS-CoV-2 mutants, and a decline in vaccine effectiveness against SARS-CoV-2 infection and COVID-19 with time since primary vaccinations. These factors have led to consideration of the potential need for, and optimal timing of, booster doses for vaccinated populations. However, vaccine inequality, lack of availability of the same vaccine product used for primary vaccinations and unpredictable vaccine supply remain a challenge in LMIC. Consideration of heterologous COVID-19 vaccine to allow interchangeability (mix and match) use of vaccine products available in LMIC would therefore allow for programmatic flexibility.</p>\n<p>\n Based on a recent systematic review and meta-regression analysis, across the four WHO EUL COVID-19 vaccines with the most data (i.e., BNT162b2, mRNA 1273, Ad26.COV2.S and ChAdOx1-S [recombinant] vaccine), vaccine effectiveness against severe COVID-19 decreased by about 8% (95% confidence interval (CI): 4-15%) over a period of 6 months in all age groups. In adults above 50 years, vaccine effectiveness against severe disease decreased by about 10% (95% CI: 6 – 15%) over the same period. Vaccine effectiveness against symptomatic disease decreased by 32% (95% CI: 11 – 69%) for those above 50 years of age. For some inactivated vaccines (CoronaVac and COVID-19 vaccine BIBP), WHO has already issued the recommendation for the administration of an additional dose to those aged 60 years or older as part of the primary series to make initial immunity more robust.</p>\n<p>\n The FDA issued a EUA for the Janssen Ad26.COV.S1 COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. In September 2021, both the single dose and 2 dose Janssen COVID-19 vaccine regimens demonstrated high efficacy (79% protection (CI, 77%-80%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations. vs 94% (CI, 58%-100%) protection against symptomatic COVID-19 in the U.S. respectively. Furthermore, the safety profile of the vaccine remained consistent and generally well-tolerated in the 2 regimens. Finally, when a booster of the Janssen COVID-19 vaccine given 6 months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.</p>\n<p>\n On June 14, 2021, Novavax reported the results of its PREVENT-19 pivotal Phase 3 trial of the NVX-CoV2373. The results showed an overall vaccine efficacy of 90.4% (95% CI: 82.9 – 94.6) in the US and Mexico. Sequenced data showed a vaccine efficacy was 93.2% (95% CI: 83.9 – 97.1) against Variants of Concern and Variants of Interest which represented 82% of cases. Studies of NVX-CoV2373 with Matrix-M adjuvant have demonstrated an acceptable safety and reactogenicity profile in adults ≥18 years of age. On December 20, 2021, the WHO issued interim recommendations and authorized under its emergency use listing (EUL) procedure, the NVX-CoV2373 COVID-19 vaccine developed by Novavax and Serum Institute of India.</p>\n<p>\n The FDA and WHO have both recommended continued evaluation of vaccine effectiveness following issuance of a EUA and/or licensure which is critical to address the existing uncertainties, with high urgency to understand homologous and heterologous boosting, both for improved coverage of variants of concern and due to limitations of global vaccine availability. The VIBRI Consortium proposes to carry out a Multi-Centre Phase 2b RCT to evaluate the Safety and Immunogenicity of the Janssen Ad26COVS1 and the Novavax NVX-CoV2373 used as homologous and heterologous boost strategies among HIV positive adolescents and adults with a small control arm of HIV (-) participants. The trial will enroll about 300 HIV(+) adolescents 12-17 years and about 1,650 adults aged 12 to 64 years, who have completed a primary series with a homologous vaccine series based on any one platform of a) mRNA (Moderna or Pfizer), b) adenovirus 26 (J&J) or c) inactivated (Sinopharm). These three have been the main vaccine platforms introduced across the three participating countries (Kenya, Democratic Republic of Congo and Rwanda) as of the current protocol. Participants must have completed the primary series 3-6 months prior to enrollment.</p>\n<p>\n Given the difference in vaccine rollout between countries, the timing of enrollment within each country is expected to stagger. All participants will be randomized 1:1 within their primary vaccine platform to receive either a single dose of either Janssen Ad26COVS1 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. Due to the uncertainty of vaccine supply and to allow for adequate capture of participants, the pre-booster vaccination enrollment period may vary anywhere from -85 days to 0 days till the time of boost (Day 0).</p>\n
      • study_title<p>\n A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 and Novavax NVX-CoV2373 COVID-19 vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda).</p>\n
      • laymans_summary<p>\n COVID-19 is a worldwide disease that emerged in the human population in Wuhan, China in December 2019. As of January 2022, there were over 328 million cases worldwide and over 5.54 million deaths as a result of the infection. According to WHO Situation Report obtained 17 January 2022, Africa has 7 million confirmed cases with over 160, 804 deaths. The worldwide disease (pandemic) has caused global suffering, mortality, and severe economic pressures, hence the urgent global need to develop effective and safe vaccines and drugs to make them available at scale and equitably across all countries. Despite the rapid successes in vaccine development, the World Health Organization and US Food and Drug Administration (FDA) have reported that the COVID-19 vaccines require additional information that was not available from the big vaccine studies. Africa has a high burden of HIV with Kenya having about 5% of the population infected and in some counties in Western Kenya reporting as high as 20% of the population according to the National AIDS and STI Control Programme (NASCOP) in 2020.</p>\n<p>\n Emerging variants of concern such as Delta and Omicron, have led to new waves of COVID-19 cases worldwide and caused public health problems. Studies suggest that some individuals, especially those with poor immunity, who received either a single dose or two doses of primary vaccination against COVID-19, developed only a weak immune response to the disease. However, other studies have shown reducing immunity to primary vaccination against new cases, and a declining vaccine effectiveness against COVID-19 from about 6 months after primary vaccinations. These factors have led to consideration of the need for booster doses for vaccinated populations.</p>\n<p>\n A few studies have shown that some of the WHO approved COVID-19 vaccines are more effective when a mix and match primary and boosting schedules is used, by reducing in the number of severe COVID-19 disease and hospital admissions. Studies are currently being done on emerging COVID-19 variants, vaccine constraints, and the need to achieve a broad immune response based on mix and match boosting strategies. There is need for additional studies to assess how effective the vaccines are in the context of heterologous boost in populations with low immunity in order to address existing gaps in medical information.</p>\n<p>\n The Victoria Biomedical Research Institute (VIBRI) in Kenya, together with research partners from Kenya, Rwanda and the Democratic Republic of Congo plan to conduct a vaccine study in these countries to assess safety, and immune responses seen when a mix and match booster vaccination schedule is given to participants, how long the immune responses last after the booster and monitoring for new COVID-19 cases after vaccination. The study is important because it addresses the need for more people to access COVID-19 vaccines and make it more equal and also protects our population from shortage of vaccine supplies.</p>\n
      • short_titleVIBRI COVID-19-001/2021
      • protocol_noECCT/22/03/04
      • version_no2.0
      • date_of_protocol28-02-2022
      • study_drugJanssen Ad26COVS1 and Novavax NVX-CoV2373
      • disease_conditionCOVID-19
      • 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
      • comparatorYes
      • comparator_nameJanssen Ad.26COV2.S1 and Novavax NVX-CoV2373 in the HIV negative participants.
      • comparator_registeredJanssen Ad.26COV2.S1
      • comparator_countriesJanssen Ad.26COV2.S1is registered in over 126 countries including Kenya, South Africa, Ghana,European Union, USA, Canada, united Kingdom, Uganda, Tanzania 1. Afghanistan\n2. Andorra\n3. Argentina\n4. Bahamas\n5. Bahrain \n6. Bangladesh \n7. Benin\n8. Bolivia\n9. Botswana\n10. Brazil\n11. Brunei\n12. Burkina Faso\n13. Cambodia\n14. Cameroon\n15. Central African Republic\n16. Chile\n17. Colombia\n18. Congo-Kinshasa\n19. Djibouti\n20. Egypt\n21. Eswatini\n22. Ethiopia\n23. Gabon\n24. Ghana\n25. Guinea\n26. Honduras\n27. India\n28. Indonesia\n29. Iran\n30. Ivory Coast\n31. Jordan\n32. Kenya\n33. Kuwait\n34. Laos\n35. Lesotho\n36. Liberia\n37. Libya\n38. Madagascar\n39. Malawi\n40. Malaysia\n41. Maldives\n42. Mali\n43. Marshall Islands\n44. Mauritania\n45. Mexico \n46. Micronesia\n47. Moldova\n48. Morocco\n49. Mozambique\n50. Namibia\n51. Nepal\n52. New Zealand\n53. Nicaragua\n54. Nigeria\n55. Palau\n56. Palestine\n57. Papua New Guinea\n58. Peru\n59. Philippines\n60. Qatar\n61. Rwanda\n62. Saudi Arabia\n63. Senegal\n64. Singapore\n65. Somalia\n66. South Africa\n67. South Korea\n68. South Sudan\n69. Sudan\n70. Syria\n71. Taiwan \n72. Tanzania\n73. Thailand\n74. Tunisia\n75. Uganda\n76. Ukraine\n77. United Kingdom\n78. United States \n79. Vietnam \n80. Yemen\n81. Zambia \n82. Zimbabwe\nEMA countries \n1. Austria\n2. Belgium\n3. Bulgaria\n4. Croatia\n5. Cyprus\n6. Czech Republic\n7. Denmark\n8. Estonia\n9. Finland\n10. France\n11. Germany\n12. Greece\n13. Hungary\n14. Iceland\n15. Ireland\n16. Italy\n17. Latvia\n18. Liechtenstein\n19. Lithuania\n20. Luxembourg\n21. Malta\n22. Netherlands\n23. Norway\n24. Poland\n25. Portugal\n26. Romania\n27. Slovakia\n28. Slovenia\n29. Spain\n30. Sweden\nCARPHA countries\n1. Antigua and Barbuda\n2. Bahamas\n3. Barbados\n4. Belize\n5. Dominica\n6. Grenada\n7. Guyana\n8. Haiti\n9. Jamaica\n10. Saint Kitts and Nevis\n11. Saint Lucia\n12. Saint Vincent and the Grenadines\n13. Suriname\n14. Trinidad and Tobago\n\nNon-country entities \n• American Samoa\n• Anguilla\n• Aruba\n• Bermuda\n• British Virgin Islands\n• Caribbean Netherlands\n• Cayman Islands\n• Curaçao\n• French Polynesia\n• Greenland\n• Guam\n• Montserrat\n• New Caledonia\n• Northern Cyprus\n• Northern Mariana Islands\n• Puerto Rico\n• Sint Maarten\n• Turks and Caicos Islands\n\n\n\n.Novavax NVX-CoV2373 is registered in over 36 coutries e.g. • India \n• Indonesia \n• New Zealand \n• Philippines \n• Singapore\n• United Kingdom\n\n• Austria \n• Belgium \n• Bulgaria \n• Croatia \n• Cyprus \n• Czech Republic \n• Denmark \n• Estonia \n• Finland \n• France \n• Germany \n• Greece\n• Hungary \n• Iceland \n• Ireland \n• Italy \n• Latvia \n• Liechtenstein \n• Lithuania \n• Luxembourg \n• Malta \n• Netherlands \n• Norway \n• Poland\n• Portugal \n• Romania \n• Slovakia \n• Slovenia \n• Spain \n• Sweden\n• Hong Kong \n• Palau \n• Panama \n• St. Kitts and Nevis \n• St. Lucia\n• St. Vincent and the Grenadines \n• Switzerland \n• Turkey \n• United Arab Emirates \n• United States\n
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressi.omollo13@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
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      • applicant_approval_letter0
      • applicant_statement1
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      • 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)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Lucas Otieno Tina
      • declaration_date111-03-2022
      • declaration_principal_investigatorPrincipal Investigator
      • declaration_date211-03-2022
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary safety Objectives</strong></p>\n<p>\n 1. To evaluate reactogenicity (solicited adverse events (AEs) Ad26.COV2S1 and NVX-CoV2372 following boosting. 2. To evaluate Serious Adverse events related to vaccination of Ad26.COV2S1 or NVX-CoV2372 during the entire study.</p>\n<p>\n <strong>Primary Immunogenicity Objectives</strong></p>\n<p>\n To evaluate the immunogenicity of Ad26.COV2S1 and NVX-CoV2372 vaccines at day 28.</p>\n<p>\n <strong>Secondary safety Objectives</strong></p>\n<p>\n 1.To evaluate all unsolicited AEs post-vaccination through 28 days and treatment emergent adverse events through 85 days in all participants. 2.To evaluate safety in terms of adverse events of special interest (AESIs) following vaccination, for HIV (+) participants through end of study. 3.To describe severe adverse events through end of study in all participants.</p>\n<p>\n <strong>Secondary Immunogenicity Objectives</strong></p>\n<p>\n 1.To compare the immunogenicity of heterologous boost in participants at Day 28 (IgG ELISA and neutralization). 2.To compare the durability of response through end of study (IgG ELISA and neutralization). 3.To evaluate mucosal immunogenicity of heterologous boost in participants at Day 28 (S-IgA ELISA). Exploratory Objectives 1.To evaluate the occurrence SARS-CoV-2 variants of concern in HIV (+) participants with moderate to severe disease following boosting vaccination. 2.To evaluate the Cell Mediated Immune response of Ad26.COV2S1 and NVX-CoV2372 vaccines in adults HIV (+) and HIV (-) participants. 3.To demonstrate the continued efficacy of either vaccine (Ad26.COV2S1 or NVX-CoV2372), when given in a heterologous boost setting, in the prevention of SARS-CoV-2 infection in HIV (+) and HIV (-) participants. 4.To identify a threshold of immune protection for HIV (+) and HIV (-) participants to prevent SARS-CoV-2 following vaccination.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion Criteria To be eligible for the study, each HIV (+) participants must satisfy all of the following criteria:</strong></p>\n<p>\n 1. Adolescent male or female aged ≥ 12 to 17 years at screening and adult male or female aged ≥ 18 to 64 years at screening (inclusive).</p>\n<p>\n 2. Written informed consent (and assent if adolescent), after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct.</p>\n<p>\n 3. Comply with study procedures, including potential home visits for COVID-19 follow-up.</p>\n<p>\n 4. Has completed a primary homologous vaccination series at least 3 months but no more than 6 months prior to enrollment. Vaccinations allowed include:</p>\n<p>\n a) mRNA (Moderna mRNA-1273 or Pfizer/BNT) – primary series is 2 doses</p>\n<p>\n b) Adenovector 26 (Janssen Ad26COVS1) – primary series is 1 dose;</p>\n<p>\n c) Inactivated whole virus (Sinopharm-BIBP) – primary series is 2 doses;</p>\n<p>\n 5. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 mIU/mL]) must agree to consistently use an effective method of contraception from enrolment and agree to continue adequate contraception until 12 weeks after vaccination:</p>\n<p>\n a. Condoms (male or female)</p>\n<p>\n b. Diaphragm with spermicide</p>\n<p>\n c. Cervical cap with spermicide</p>\n<p>\n d. Intrauterine device</p>\n<p>\n e. Oral or patch contraceptives</p>\n<p>\n f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®.</p>\n<p>\n g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle.</p>\n<p>\n NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These procedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.</p>\n<p>\n 6. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable Vital signs as determined by the Principal Investigator or designee.</p>\n<p>\n 7. Receiving highly active antiretroviral therapy (HAART) and using the same regimen the past 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (e.g., the conventional formulation for combination formulations) is allowed. If regimen has changed then the participant can be reconsidered for inclusion once the 8 weeks has passed.</p>\n<p>\n 8. An HIV-1 viral load < 1000 copies/mL and/or CD4 Count ≥ 200 cells/mm3 within 3 months before randomization. May be taken during screening or utilize medical testing from clinic.</p>\n<p>\n 9. Documentation of HIV positivity by HIV rapid test or assay as per the Ministry of Health guidelines in the respective countries. Each HIV (-) participant must meet all the following criteria to be enrolled in this study:</p>\n<p>\n 1. Male or female aged ≥ 18 to 64 years at screening, inclusive.</p>\n<p>\n 2. Willing and able to give informed consent prior to study enrolment and comply with study procedures, including potential home visits for COVID-19 follow-up. 3. Has completed a primary homologous vaccination series at least 3 months but no more than 6 months prior to enrollment. Vaccinations allowed include:</p>\n<p>\n a. mRNA (Moderna mRNA-1273 or Pfizer/BNT) – primary series is 2 doses</p>\n<p>\n b. Adenovector 26 (Janssen Ad26COVS1) – primary series is 1 dose;</p>\n<p>\n c. Inactivated whole virus (Sinopharm-BIBP) – primary series is 2 doses;</p>\n<p>\n 4. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 mIU/mL]) must agree to abstain from enrolment and through 6 months after the last vaccination OR agree to consistently use an effective method of contraception from enrolment and through 6 months after the last vaccination:</p>\n<p>\n a. Condoms (male or female)</p>\n<p>\n b. Diaphragm with spermicide</p>\n<p>\n c. Cervical cap with spermicide</p>\n<p>\n d. Intrauterine device</p>\n<p>\n e. Oral or patch contraceptives</p>\n<p>\n f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®.</p>\n<p>\n g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle.</p>\n<p>\n NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These procedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.</p>\n<p>\n 5. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable vital signs by PI.</p>\n<p>\n 6. Documentation of negative HIV rapid test (or assay) as per the Ministry of Health guidelines in the respective countries.</p>\n
      • principal_exclusion_criteria<p>\n <strong>Participants with any of the following criteria will be excluded:</strong></p>\n<p>\n 1. Use of a heterologous COVID-19 primary series at the platform level (mRNA, Adenovector and inactivated vaccine).</p>\n<p>\n 2. Use of an extended primary vaccination series or prior booster with any SARS-COV2 vaccine.</p>\n<p>\n 3. Any subject with prior Adverse Events of Special Interest Relevant to COVID-19 (see table 6).</p>\n<p>\n 4. Unstable or Severe Chronic disease inclusive of:</p>\n<p>\n a. Hypertension (elevated blood pressure [SBP>160mmHg or DBP>100mmHg]). Note that participants can be retested once after resting or return on another day for retesting. Participants may also have anti-hypertensive medication adjusted and may be reassessed after at least 2 weeks.</p>\n<p>\n b. Congestive heart failure (CHF) stage 3 or greater or diagnosed cardiovascular disease that is not controlled using medication in the past 6 months.</p>\n<p>\n c. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbations repeated in the past 2 years. Note: If participant has been stable the last 6 months and are not Gold stage 3 or greater, they may be included.</p>\n<p>\n d. Asthma stage 4 and/or unstable cases with asthma therapy adjustments in the past that 2 months.</p>\n<p>\n e. Type 1 or any type 2 diabetes (adult onset) of severe grade by history/medical review or with an HbA1c > 8.5 in the last 6 months.</p>\n<p>\n f. Chronic kidney disease requiring dialysis or GFR <30 (may use associated creatinine based on age and gender).</p>\n<p>\n g. Chronic hepatic disease with evidence of hepatic compromise by history/medical review. Includes known Hepatitis B or C.</p>\n<p>\n h) Chronic or serious neurological diseases (e.g. cerebrovascular disease (including transient ischemic attacks), autoimmune disorders, neurologic deterioration (including dementia), Guillain Barre syndrome).</p>\n<p>\n i) Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness of severe grade or that is not stable over the past 6 months (at the discretion of the investigator).</p>\n<p>\n j) HIV Stage III/IV</p>\n<p>\n 5. Cognitive impairment – congenital or acquired</p>\n<p>\n 6. A child in care i.e., a child who is in the custody, care or guardianship of a director or a director of adoption.</p>\n<p>\n 7. Participation in research involving an investigational product (drug/biologic/device) within 30 days prior to first study vaccination and planned participation during this study. Exception is if participant in a follow up safety phase and the investigation product has been given > 6 months previously.</p>\n<p>\n 8. Prior receipt of an Ebola vaccine i.e., Ad26.ZEBOV/MVA-BN-Filo vaccines.</p>\n<p>\n 9. Received any other vaccine within 4 weeks prior to first study vaccination or planned vaccination within 4 weeks after study vaccination (including mass vaccination campaigns). Participants may be revaluated after the window has passed.</p>\n<p>\n 10. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital), excluding HIV. Note: Stable endocrine disorders that have a confirmed autoimmune etiology (e.g., thyroid, pancreatic), including stable diabetes are allowed.</p>\n<p>\n 11. Chronic administration (>14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 60 days prior to first study vaccination, excluding HAART. Note: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.</p>\n<p>\n 12. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination, excluding HAART.</p>\n<p>\n 13. Known disturbance of coagulation (iatrogenic or congenital). Note: The use of low-dose aspirin (≤ 325 mg/day) as prophylaxis is acceptable in dosages consistent with local standards of care, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease.</p>\n<p>\n 14. Any disease or disorder that would indicate a life expectancy less than 3 years such as active cancer.</p>\n<p>\n 15. Any known allergies to products contained in the investigational product or latex allergy or any history of anaphylaxis in relation to any previous vaccination. 16. Women who are breastfeeding or who are pregnant at the time of screening or plan to become pregnant within the first 12 months of the study.</p>\n<p>\n 17. A serious adverse event that occurs between screening and randomization. Subjects will not be allowed to be randomized.</p>\n<p>\n 18. History of alcohol abuse or drug addiction within 2 years prior to the first study vaccination.</p>\n<p>\n 19. Any condition (other than HIV) that, in the opinion of the investigator, would pose a health risk to the participant if enrolled (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).</p>\n<p>\n 20. Study team member or first-degree relative of any study team member (inclusive of sponsor, and site personnel involved in the study).</p>\n<p>\n <strong>Temporary exclusions: </strong></p>\n<p>\n 21. Acute respiratory and/or non-respiratory illness or documented temperature of > 38°C in the past 24 hours. Note: Participant may be re-evaluated after symptoms have resolved for at least 3 days.</p>\n<p>\n 22. Positive RT-PCR SARS-CoV-2 test during screening or at time of randomization. Subject must be SARS-COV-2 symptom free and have a negative test prior to randomization. 23. Documented severe SARS-CoV-2 infection in the last 3 months. May be rescreened when this period has passed.</p>\n
      • primary_end_points<p>\n <strong>Primary safety end points:</strong></p>\n<p>\n 1. Occurrence of solicited AEs (local and systemic) reactogenicity events through 7 days following boosting vaccination. Analysis to include by HIV status, age group, booster treatment group, and heterologous vaccination series (primary platform + boosted vaccine).</p>\n<p>\n 2. Incidence of vaccine related Serious Adverse Events (SAEs) throughout the study period. Analysis to include by HIV status, age group, booster treatment group, and heterologous vaccination series (primary platform + boosted vaccine).</p>\n<p>\n <strong>Primary Immunogenicity end points: </strong></p>\n<p>\n 1. SARS-CoV-2 neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay (VNA) using pseudovirion expressing S protein (standardized to 50% neutralization with 95% CI).</p>\n<p>\n 2. Serum IgG antibodies to SARS-CoV-2 rS protein measured by enzyme-linked immunosorbent assay (ELISA) using geometric mean titers (GMT with 95% CI). 3. Geometric mean fold ratio over baseline (IgG and VNA). Analysis to include by HIV status, age group and booster treatment group (Ad26.COV2S1 or NVX-CoV2373)</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity, prevention
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The site is equiped to conduct clinical trials with qualified site Investigators and personnel by experience, eduaction and training. The site has emergency facilities, both clinical and laboratory equipment including adequate facilities to conduct the trials i.e.Participant wating area/Reception, vital site stations, Clinical rooms, Laboratory, Study Pharmacy, data entry room, conference room, monitoring room and administrative offices. Study site is located within the Kisumu County Referal Hospital and therfore has access to outpatient, inpatient facilities and medical personnel within the Hospital.</p>\n<p>\n Below is a list of staff names with their roles:</p>\n<p>\n <strong>Name:                    Role:</strong></p>\n<p>\n Lucas Otieno Tina- PI</p>\n<p>\n Walter Otieno- Sub-I</p>\n<p>\n Dismas Oketch- Sub-I</p>\n<p>\n Henry Nyongesa- Sub-I</p>\n<p>\n Antony Oindo- Sub-I</p>\n<p>\n Millicent Melanie- Pharmacist</p>\n<p>\n Anne Rogena -Pharmacist</p>\n<p>\n David Ogolla- Project Manager</p>\n<p>\n Geoffrey Olado- CRC</p>\n<p>\n Brenda Okuba -CRC</p>\n<p>\n Jew Ochola -Lab Manager</p>\n<p>\n Vincent Omondi- Lab Tech</p>\n<p>\n Nicakanor Odiwour -Lab Tech</p>\n<p>\n Eunice Oyola- Clinician</p>\n<p>\n Leah Martha Atieno -Clinician</p>\n<p>\n Annette Imojong Onyamasi- Nurse</p>\n<p>\n Gaudensia Oyugi Nyauke- Nurse</p>\n<p>\n Jane Atieno Oriato- Nurse</p>\n<p>\n Lydiah Otitah- Data clerk</p>\n<p>\n Franciscah Awino -Data clerk</p>\n<p>\n Alfred Ochieng Data clerk</p>\n<p>\n Fredrick Otieno- Field coordinator</p>\n<p>\n Serphine Wamboga- Field</p>\n<p>\n Edith Aluoch Field- Assistant</p>\n<p>\n Paul Osodo HTS -provider</p>\n<p>\n Sharon Omollo- Procurement</p>\n<p>\n Josephine Akinyi -Administrator</p>\n<p>\n Mary Onyango- HR</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n 1. Rwanda FDA-Submission Feb  2022.</p>\n<p>\n 2. Directorate of Pharmacy and Medicine (Direction de la Pharmacie et du Médicament (DPM) planned for Mar 2022.</p>\n
      • other_details_regulatory_approved<p>\n Approval still pending for Rwanda and DRC</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator Ad.26COV2.S1, NVX-CoV237
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaVictoria Biomedical Research Institute,
      • single_site_physical_addressKisumu Country Referal Hospital
      • single_site_contact_personDr. Lucas Otieno Tina
      • single_site_telephone+ 254 720 597654
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listRwanda and Democratic Republic of Congo(DRC)
      • data_monitoring_committeeYes
      • total_enrolment_per_siteOne site participating in Kenya. 1000 participants for the participating Kenyan site.
      • total_participants_worldwide1950
      • 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_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Lucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationMBChB, MSc. DLSHTM
      • investigator1_professional_addressVictoria Biomedical Research Institute, Kisumu County Hospital, P.O. Box 7180-40100, Kisumu, Kenya
      • investigator1_telephone+ 254 720 597654
      • investigator1_emailItina@vibriafrica.org
      • organisations_transferred_Yes
      • number_participants1000 participants.
      • notification
      • approval_date04-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-04-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonComments raised by reviewers have been addressed sufficiently
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-10 13:52:32
      • created2022-03-01 10:22:56
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id796
        • application_id1125
        • given_nameDr. Lucas
        • middle_nameOtieno
        • family_nameTina
        • qualificationMBChB, MSc. DLSHTM
        • professional_addressVictoria Biomedical Research Institute, Kisumu County Hospital, P.O. Box 7180-40100, Kisumu, Kenya
        • telephone+ 254 720 597654
        • emailItina@vibriafrica.org
        • created2022-03-01 10:37:38
        • modified2022-04-28 15:27:34
    • SiteDetail(array)
      • 0(array)
        • id1250
        • application_id1125
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-03-01 10:37:38
        • modified2022-04-28 15:27:34
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id580
        • application_id1125
        • sponsorVictoria Biomedical Research Institute
        • sponsor_typeResearch Institution
        • contact_personDr. Lucas Otieno Tina
        • addressVictoria Biomedical Research Institute, Kisumu County Referal Hospital, P.O. Box 7180-40100, Kisumu, Kenya
        • telephone_number+ 254 720 597654
        • fax_number
        • cell_number+ 254 720 597654
        • email_addressItina@vibriafrica.org
        • created2022-03-01 10:37:38
        • modified2022-04-28 15:27:34
  • 3(array)
    • Application(array)
      • id1126
      • user_id613
      • trial_status_id7
      • abstract_of_study<p>\n Globally in 2017, more than 35 million people were living with HIV, and 1.8 million people were newly infected with the virus (4). There were 940,000 deaths attributable to HIV infection. According to Kenya Ministry of Health report of 2017, there were approximately 52,800 new infections across all ages; 44,800 among adults aged 15+ years and 8,000 among children. The recent discovery of multiple potent and broadly neutralizing antibodies (bnAbs) against HIV has led to the re-emergence of the concept that passive administration of antibodies may be useful for prevention of HIV. A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV-uninfected adult participants. Primary objective of the study is to evaluate the safety and tolerability of PGDM1400LS when administered via intravenous (IV) or subcutaneous (SC) routes (Part A) and of PGDM1400LS + VRC07-523LS + PGT121.414.LS when administered in sequence IV or SC (Part B), evaluate the serum concentrations and pharmacokinetics of PGDM1400LS after a single administration (Part A) and of PGDM1400LS + VRC07-523LS + PGT121.414.LS after each three-mAb administration (Part B), and to evaluate the individual mAb-specific serum neutralizing activity after single product administration of PGDM1400LS (Part A) and after each three-mAb administration of PGDM1400LS, VRC07-523LS and PGT121.414.LS (Part B). The study products are; PGDM1400LS: a human mAb that targets the HIV-1 V2 glycan, PGT121. 414.LS is a human mAb that targets the HIV-1 V3 glycan centered on N332 and VRC-HIVMAB075-00-AB (VRC07-523LS) is a human mAb that targets the HIV-1 CD4 binding site. About 95 healthy, HIV-1–uninfected volunteers aged 18 through 50 years with a study duration per participant being 6 months in Part A and 10 months in Part B. Kericho site is looking at screening 60 participants to enroll up to 30 participants. The study’s estimated total duration is 14 months (includes enrollment, planned safety holds, and follow-up).</p>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p>\n A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV-uninfected adult participants_HVTN 140/HPTN 101</p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Antibodies are one of the natural ways that our bodies fight infection. Giving people antibodies to prevent infection has been an accepted medical practice for more than 100 years. For example, doctors give people antibodies to prevent infections like hepatitis A or B and chicken pox. Some antibodies that are used for preventing infections are made in laboratories. Manufactured antibodies have been used to prevent a dangerous respiratory infection in infants called RSV, and to treat diseases such as COVID-19, rheumatoid arthritis and breast cancer.</p>\n<p>\n The study HVTN 140/HPTN 101 tests three antibodies against HIV. The antibodies are called PGDM1400LS, PGT121.414.LS and VRC07-523LS. Since antibodies are part of how the body naturally protects against infections, these antibodies cannot cause HIV.</p>\n<p>\n The study antibodies were developed from antibodies discovered in the blood of people who were living with HIV. Some antibodies made by people living with HIV can block (neutralize) many different strains of HIV. These are called broadly neutralizing antibodies, or bnAbs. These antibodies attack HIV by attaching to key spots on the surface of the virus and blocking it from infecting human cells. The three study antibodies attach to different spots on HIV’s surface. Some of these natural bnAbs have been copied and made in a lab to create the study antibodies. The study antibodies have been shown to block many different global HIV strains in laboratory tests.</p>\n<p>\n Because no single bnAb discovered so far can block all global strains of HIV, scientists think that using combinations of different bnAbs may block more HIV strains. They think that using combinations may be more effective to prevent HIV.</p>\n<p>\n In this study, the PGDM1400LS study antibody will be tested by itself at different doses and in combination with the PGT121.414.LS and VRC07-523LS antibodies. The study antibodies will be given by intravenous (IV) (into the vein) or subcutaneous (SC) (under the skin) infusion.</p>\n<p>\n The main goals of this study are to see if the study antibodies are safe to give to people, and whether people are able to take the antibodies without becoming too uncomfortable.</p>\n<p>\n Other questions we are trying to answer with this study are:</p>\n<p>\n ·         Is the new PGDM1400LS study antibody safe to give to people at different doses?</p>\n<p>\n ·         Are the 3 study antibodies safe to give to people <u>together</u> at different doses?</p>\n<p>\n ·         How much of the study antibodies remain in the body as time passes?</p>\n<p>\n ·         How do people’s immune systems respond to the study antibodies? (Your immune system protects you from disease.)</p>\n<p>\n ·         Does the method of giving the antibodies (IV or SC infusion) change the body’s response?</p>\n<p>\n This study is expected to take about 14 months. Kericho site is planning to enroll up to 30 participants.</p>\n<p>\n  </p>\n
      • short_titleHVTN 140/HPTN 101
      • protocol_noECCT/22/03/03
      • version_no1
      • date_of_protocol23-06-2021
      • study_drugPGDM1400LS ,VRC07-523LS and PGT121.414.LS
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_namePGDM1400LS mAb
      • product_type_medical_device_nameN/A
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.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_applicantJosphat Kosgei
      • declaration_date108-03-2022
      • declaration_principal_investigatorDr Fredrick Sawe
      • declaration_date208-03-2022
      • placebo_presentNo
      • study_objectives<h1>\n primary objectives</h1>\n<ul>\n <li>\n To evaluate the safety and tolerability of PGDM1400LS when administered via intravenous (IV) or subcutaneous (SC) routes (Part A) and of PGDM1400LS + VRC07-523LS + PGT121.414.LS when administered in sequence IV or SC (Part B)</li>\n <li>\n To evaluate the serum concentrations and pharmacokinetics of PGDM1400LS after a single administration (Part A) and of PGDM1400LS + VRC07-523LS + PGT121.414.LS after each three-mAb administration (Part B)</li>\n <li>\n To evaluate the individual mAb-specific serum neutralizing activity after single product administration of PGDM1400LS (Part A) and after each three-mAb administration of PGDM1400LS, VRC07-523LS and PGT121.414.LS (Part B)</li>\n</ul>\n<h2>\n Secondary and Exploratory Objectives are captured in Section 5.3 and 5.4 of the main protocol.</h2>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n General and Demographic Criteria</p>\n<ol>\n <li>\n <strong>Age</strong> of 18 through 50 years</li>\n <li>\n <strong>Access to a participating CRS</strong> and willingness to be followed for the planned duration of the study</li>\n <li>\n Ability and willingness to provide <strong>informed consent</strong></li>\n <li>\n <strong>Assessment of understanding</strong>: volunteer demonstrates understanding of this study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly</li>\n <li>\n <strong>Agrees not to enroll in another study</strong> of an investigational research agent until completion of the last required protocol clinic visit.</li>\n <li>\n <strong>Good general health</strong> as shown by medical history, physical exam, and screening laboratory test</li>\n</ol>\n<p>\n  </p>\n<p>\n HIV-Related Criteria:</p>\n<p>\n 1.     Willingness to receive <strong>HIV test results</strong></p>\n<p>\n 2.     Willingness to discuss <strong>HIV infection risks</strong> and amenable to HIV risk reduction counseling.</p>\n<p>\n 3. Assessed by the clinic staff as being at <strong>“low risk” for HIV infection</strong> and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit </p>\n<p>\n more infromation is foin in section 7.1 and 7.2 of the main protocol.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n Determination of eligibility, taking into account all inclusion and exclusion criteria, must be made within 56 days prior to enrollment as noted in Sections 7.1 and 7.2 of the main protocol</p>\n
      • primary_end_points<p>\n Primary endpoints 1:</p>\n<ul>\n <li>\n Local and systemic Solicited AEs, laboratory measures of safety, Unsolicited AEs, and SAEs</li>\n <li>\n Early discontinuation of administration and reason(s) for discontinuation and early study termination</li>\n</ul>\n<p>\n Primary endpoint 2:</p>\n<p>\n Serum concentrations of PGDM1400LS, VRC07-523LS and PGT121.414.LS at prespecified timepoints among participants who received all scheduled product administrations</p>\n<p>\n  </p>\n<p>\n Primary endpoint 3:</p>\n<p>\n Magnitude and breadth of neutralizing activity measured with Env pseudotyped viruses specific for either PGDM1400LS, VRC07-523LS or PGT121.414LS in TZM-bl cells at prespecified timepoints among participants who received all scheduled product administrations.</p>\n<p>\n  </p>\n<p>\n <em>Secondary endpoints 1:</em></p>\n<ul>\n <li>\n Serum concentrations of PGDM1400LS, VRC07-523LS and PGT121.414.LS at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received</li>\n <li>\n Magnitude of serum neutralizing activity measured with mAb-specific Env-pseudotyped viruses in TZM-bl cells at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received</li>\n</ul>\n<p>\n <em>Secondary endpoint 2:</em></p>\n<p>\n Magnitude of neutralizing activity against a panel of Env-pseudotyped reference viruses that are sensitive to all three bnAbs in TZM-bl cells at selected timepoints for all participants in all groups regardless of how many product administrations and how much product they received</p>\n<p>\n <em>Secondary endpoint 3:</em></p>\n<p>\n ADA titers in each group measured at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received</p>\n<p>\n Secondary endpoint 4:</p>\n<p>\n Serum concentrations of PGDM1400LS, VRC07-523LS and PGT121.414.LS at prespecified timepoints</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • 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_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:5.75pt;\">\n The Kericho CRC is equipped with two emergency rooms (one per floor) equipped with equipment and medications to provide immediate emergency care in the event of emergencies such as anaphylaxis during vaccinations. Additionally, the Kericho site has a standby, fully equipped ambulance for evacuation of participants for more specialized care when necessary. The study staff (clinicians/nurses) are trained on handling emergencies.</p>\n<p style=\"margin-left:5.75pt;\">\n The Kericho site has previously conducted three first-in-human studies. The site has a long-standing experience in conducting more than 52 studies including clinical trials, ranging from therapeutics, vaccines (HIV, Polio, Ebola) and cohort studies. The clinical trials range from phase I to IV with age ranges from birth to the elderly, some of which are randomized double blind, placebo controlled and IND/FDA-regulated. The site has conducted three Phase I HIV vaccine trials, Phase I Polio and Ebola vaccine clinical trials. Kericho CRC has a total of 152 staff with the necessary professional backgrounds and experience to support the clinical trials. The staff consist of 6 doctors (one obstetrician/gynecologist, two infectious disease doctors, one public health physician, a consultant pediatrician, and a medical officer), 15 clinical officers, two pharmacists, one pharmaceutical technologist, and 24 nurses.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Globally in 2017, more than 35 million people were living with HIV, and 1.8 million people were newly infected with the virus (4). There were 940,000 deaths attributable to HIV infection. According to Kenya Ministry of Health report of 2017, there were approximately 52,800 new infections across all ages; 44,800 among adults aged 15+ years and 8,000 among children. The recent discovery of multiple potent and broadly neutralizing antibodies (bnAbs) against HIV has led to the re-emergence of the concept that passive administration of antibodies may be useful for prevention of HIV.</p>\n
      • other_details_regulatory_notapproved<p>\n WRAIR IRB, USA</p>\n
      • other_details_regulatory_approved<p>\n SERU, KEMRI</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration14 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_stateYes
      • location_of_areaKEMRI WRP, KERICHO
      • single_site_physical_addressOFF HOSPITAL ROAD
      • single_site_contact_personJOSPHAT KOSGEI
      • single_site_telephone0729110122
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listUSA, South Africa, Kenya and Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site30
      • total_participants_worldwide95
      • 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_elderlyYes
      • 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_nameFredrick
      • investigator1_middle_name
      • investigator1_family_nameSawe
      • investigator1_qualificationMBchB, MMED
      • investigator1_professional_address1357, Kericho
      • investigator1_telephone0703247902
      • investigator1_emailFredrick.sawe@usamru-k.org
      • organisations_transferred_No
      • number_participants30
      • notification
      • approval_date12-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer concerns have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-14 10:03:39
      • created2022-03-07 12:02:15
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id797
        • application_id1126
        • given_nameJosphat
        • middle_name
        • family_namekosgei
        • qualificationMBchB, MSc
        • professional_address1357, Kericho
        • telephone0729110122
        • emailJosphat.kosgei@usamru-k.org
        • created2022-03-07 12:43:41
        • modified2022-03-18 11:29:18
    • SiteDetail(array)
      • 0(array)
        • id1251
        • application_id1126
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-03-07 12:43:41
        • modified2022-03-18 11:29:18
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id581
        • application_id1126
        • sponsorDAIDS
        • sponsor_typeResearch Institution
        • contact_person
        • addressUSA
        • telephone_number202-741-2165
        • fax_number
        • cell_number202-741-2165
        • email_addressmsiegel@mfa.gwu.edu
        • created2022-03-07 12:43:41
        • modified2022-03-18 11:29:18
  • 4(array)
    • Application(array)
      • id1120
      • user_id667
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong></p>\n<p>\n COVID-19, a disease resulting from SARS-CoV-2 infection, was declared a global pandemic by the WHO on 11-MAR-2020. As of early December 2021, more than 170 million confirmed cases of SARS-CoV-2 infection and over 3.5 million COVID-19-related deaths have been reported globally. Molnupiravir (MOV) is a novel ribonucleoside analog prodrug with broad-spectrum antiviral activity against a range of RNA viruses, including coronaviruses. MOV is being developed as an oral prophylactic for COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) in initially asymptomatic individuals’ ≥18 years of age residing with a person with COVID-19.</p>\n<p>\n <strong>Justification:</strong></p>\n<p>\n The constant mutations leading to SARS-CoV-2 variants that have been associated with gradual increase in cases and hospitalizations has brought about high unmet medical need for new, effective therapies and prophylactics. MOV has been shown to inhibit replication of viral pathogens from multiple RNA virus families in vitro, including the highly pathogenic coronaviruses (SARS-CoV-2, MERS-CoV), as well as influenza virus, RSV, filoviruses, flaviviruses, chikungunya virus, and alphaviruses.</p>\n<p>\n <strong>Objectives:</strong>  Objectives of this study will be evaluated in participants ≥18 years of age who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual (of any age) with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms), defined as the index case. The primary objective of this study is to evaluate the efficacy, safety and tolerability of Molnupiravir (MOV) compared with placebo for the prevention of laboratory-confirmed COVID-19 through Day 14 in participants (regardless of baseline viral test result) who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual with COVID19. These will be measured by laboratory-confirmed SARS-CoV-2 infection with symptoms and adverse events and adverse events leading to discontinuation of the study intervention. The secondary objectives of this study are: 1) To evaluate the efficacy of MOV compared with placebo for the prevention of laboratory confirmed COVID-19 through Day 14 in participants with undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs as measured by laboratory confirmed SARS-CoV-2 infection with symptoms; 2) To evaluate the efficacy of MOV compared with placebo for the prevention of laboratory-confirmed COVID-19 through Day 29 in participants who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual with COVID19 as measured by laboratory confirmed SARS-CoV-2 infection with symptoms; and 3) To evaluate prevention of viral transmission through Day 14 for MOV compared with placebo in participants with undetectable SARS-CoV-2 in baseline NP swabs as measured by laboratory confirmed SARS-CoV-2 RNA.</p>\n<p>\n <strong>Methods:</strong></p>\n<p>\n This is a Phase 3, randomized, placebo-controlled, double-blind, multi-site study to evaluate the efficacy and safety of MOV to prevent COVID-19 in participants ≥18 years of age residing with an individual (no age requirement) with COVID-19 (defined as the index case). Eligible participants who do not have confirmed or suspected COVID-19 at the time of screening and randomization will be randomized within 5 days of both the time of sample collection for the index case’s first positive SARS-CoV-2 test result and time of onset of the index case’s COVID-19 symptoms. Approximately 1332 adult participants who are household contacts of index COVID-19 cases will be randomized in a 1:1 ratio to receive either blinded MOV or blinded placebo. Index cases will not be randomized to receive intervention in the study.</p>\n<p>\n <strong>Nature of results expected:</strong></p>\n<p>\n For our primary objectives, we hypothesize that MOV will be superior to placebo for the prevention of laboratory confirmed COVID-19 through Day 14 in participants who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual with COVID-19.  For our main secondary objective, we hypothesize that MOV will be superior to placebo for the prevention of laboratory confirmed COVID-19 through Day 14 in participants with undetectable SARSCoV-2 in baseline nasopharyngeal (NP) swabs.</p>\n
      • study_title<div>\n A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19</div>\n
      • laymans_summary<p>\n Current declaration by the WHO on 11 March 2020 that COVID-19 a disease that is caused by a virus known as SARS-CoV-2, as a global pandemic. Over 170 million confirmed SARS-CoV-2infections with more than 3.5 million deaths have been reported worldwide. A drug known as Molnupiravir (MOV) which has antiviral activity against a range of viruses including coronaviruses is being developed as a drug taken orally to prevent COVID-19 in individuals >18years with no symptoms but living with a person who has been tested and confirmed to have COVID-19 with symptoms. The drug MOV has been shown to work in preventing duplication of numerous family of viruses.</p>\n<p>\n The main aim of this study is to find out if this drug can prevent COVID-19 and if it is safe and well tolerated when compared with an inactive drug for the prevention of laboratory-confirmed COVID-19 through Day 14 in participants (regardless of baseline viral test result) who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual with COVID-19.</p>\n
      • short_titleMOVe AHEAD STUDY
      • protocol_noECCT/22/03/02
      • version_no02
      • date_of_protocol07-01-2022
      • study_drugMOLNUPIRAVIR (MK-4482)
      • disease_conditionCOVID-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_nameMOLNUPIRAVIR
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrgreshon@kemri-ucsf.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. Greshon Rota
      • declaration_date108-03-2022
      • declaration_principal_investigatorProf. Elizabeth Anne Bukusi
      • declaration_date208-03-2022
      • placebo_presentYes
      • study_objectives<p>\n The primary objective of this study is to evaluate the efficacy, safety and tolerability of Molnupiravir (MOV) compared with placebo for the prevention of laboratory-confirmed COVID-19 through Day 14 in participants (regardless of baseline viral test result) who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual with COVID19. These will be measured by laboratory-confirmed SARS-CoV-2 infection with symptoms and adverse events and adverse events leading to discontinuation of the study intervention. </p>\n<p>\n The secondary objectives of this study are:</p>\n<p>\n 1) To evaluate the efficacy of MOV compared with placebo for the prevention of laboratory confirmed COVID-19 through Day 14 in participants with undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs as measured by laboratory confirmed SARS-CoV-2 infection with symptoms.</p>\n<p>\n 2) To evaluate the efficacy of MOV compared with placebo for the prevention of laboratory-confirmed COVID-19 through Day 29 in participants who do not have confirmed or suspected COVID-19 at the time of screening and randomization and are residing with an individual with COVID19 as measured by laboratory confirmed SARS-CoV-2 infection with symptoms.</p>\n<p>\n 3) To evaluate prevention of viral transmission through Day 14 for MOV compared with placebo in participants with undetectable SARS-CoV-2 in baseline NP swabs as measured by laboratory confirmed SARS-CoV-2 RNA.</p>\n
      • principal_inclusion_criteria<div>\n A participant will be eligible for inclusion in the study if the participant meets all of the</div>\n<div>\n following criteria:</div>\n<div>\n  </div>\n<div>\n Type of Participant and Disease Characteristics</div>\n<div>\n  </div>\n<div>\n 1. The participant is a household contact of an index case. An index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have:</div>\n<div>\n a) A first detectable SARS-CoV-2 test result from a sample collected ≤5 days prior to randomization of the participant(s), AND</div>\n<div>\n b) At least 1 of the following symptoms attributable to COVID-19: fever ≥38.0ºC, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, or loss of smell, with symptom onset no earlier than 5 days prior to randomization of the participant(s).</div>\n<div>\n Note:</div>\n<div>\n 2. The participant does not have confirmed or suspected COVID-19.</div>\n<div>\n 3. The participant is willing and able to take oral medication.</div>\n<div>\n  </div>\n<div>\n Demographics</div>\n<div>\n 4. The participant is male or female ≥18 years of age, at the time of providing documented</div>\n<div>\n informed consent.</div>\n<div>\n  </div>\n<div>\n Male Participants</div>\n<div>\n 5. There are no contraceptive requirements for male participants per protocol. However, where applicable, male participants are only eligible to participate if they agree to follow local labelling (or local ethics or regulatory authority requirement) regarding contraception.</div>\n<div>\n  </div>\n<div>\n Female Participants</div>\n<div>\n 6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:</div>\n<div>\n • Is not a WOCBP (woman of child-bearing potential)</div>\n<div>\n OR</div>\n<div>\n • Is a WOCBP and: - Uses a contraceptive method that is highly effective (a low user dependency method OR a user dependent hormonal method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 4 days after the last dose of study intervention.</div>\n<div>\n Informed Consent</div>\n<div>\n 7. The participant’s index case (or legally acceptable representative of the index case) has provided documented informed consent/assent for the collection of COVID-19 documentation requirements.</div>\n<div>\n Note: There is no age requirement for index cases, and they may be less than 18 years of age.</div>\n
      • principal_exclusion_criteria<div>\n The participant must be excluded from the study if the participant meets any of the following criteria:</div>\n<div>\n  </div>\n<div>\n Medical Conditions</div>\n<div>\n 1. The participant has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms), within 6 months prior to randomization.</div>\n<div>\n 2. The participant has either of the following conditions:</div>\n<div>\n ï‚· HIV with a recent viral load >50 copies/mL (regardless of CD4 count) or an AIDS defining illness in the past 6 months</div>\n<div>\n 3. The participant has a history of HBV or HCV infection with any of the following:</div>\n<div style=\"margin-left: 40px;\">\n ï‚· Cirrhosis</div>\n<div style=\"margin-left: 40px;\">\n ï‚· End-stage liver disease</div>\n<div style=\"margin-left: 40px;\">\n ï‚· Hepatocellular carcinoma</div>\n<div style=\"margin-left: 40px;\">\n ï‚· AST and/or ALT >3X upper limit of normal at screening</div>\n<div>\n 4. The participant has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.</div>\n<div>\n 5. The participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent,</div>\n<div>\n limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents.</div>\n<div>\n  </div>\n<div>\n Prior/Concomitant Therapy</div>\n<div>\n 6. The participant has received, is taking, or is anticipated to require any prohibited therapies as outlined in the protocol.</div>\n<div>\n 7. The participant has received a COVID-19 vaccine with the first dose 7 days or more prior to randomization.</div>\n<div>\n Prior/Concurrent Clinical Study Experience</div>\n<div>\n 8. The participant is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics.</div>\n
      • primary_end_points<p style=\"margin-left:1.3pt;\">\n <strong>Efficacy</strong>: Proportion of participants developing COVID-19 through Day 14</p>\n<p>\n <strong>Safety</strong>: AEs, and AEs leading to discontinuation of study intervention</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • 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_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n PI - Prof Elizabeth Bukusi, PHD</p>\n<p>\n Co-PI - Dr. Victor Omollo, MBCHB, MPH</p>\n<p>\n Co-Investigators </p>\n<p style=\"margin-left: 40px;\">\n Josephine Odoyo - BSN</p>\n<p style=\"margin-left: 40px;\">\n Kevin Kamolloh- Medical Anthropology</p>\n<p style=\"margin-left: 40px;\">\n Dr. Cynthia Aluoch - MBCHB, Study coordinator</p>\n<p style=\"margin-left: 40px;\">\n Dr. Greshon Rota - BPharm</p>\n<p>\n Study administrator - 1</p>\n<p>\n Study Clinician - 2</p>\n<p>\n Study nurse - 3</p>\n<p>\n Data analysts/QA - 3</p>\n<p>\n Lab techs - 2</p>\n<p>\n Recruitment and retention - 4</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n KENYA MEDICAL RESEARCH INSTITUTE SCIENTIFIC ETHICS REVIEW UNIT </p>\n<p>\n Application made on 3rd March 2022</p>\n
      • other_details_regulatory_approved<ol style=\"list-style-type:lower-alpha;\">\n <li>\n South African Health Products Regulatory Authority (SAHPRA) dated 16 September 2021</li>\n <li>\n University of the Witwatersrand, Johannesburg- Human ethics research committee, medical dated 3 December 2021</li>\n <li>\n PHARMA-ETHICS, South Africa dated 21 September 2021</li>\n</ol>\n<p>\n  </p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration2 Years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI RCTP KISUMU
      • single_site_physical_addressLumumba Subcounty Hospital
      • single_site_contact_personDr. Victor Omollo
      • single_site_telephone0799580808
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states19
      • number_of_sites
      • multi_country_listArgentina\nGuatemala\nPhilippines\nThailand\nBrazil\nHungary\nRomania\nTurkey\nColombia\nJapan\nRussia\nUSA\nDominican Republic\nMalaysia\nSouth Africa\nUkraine\nFrance\nMexico\nSpain
      • data_monitoring_committeeYes
      • total_enrolment_per_siteminimum 25 \n\nmaximum 150
      • total_participants_worldwide1500
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
      • investigator1_professional_addressBox 19464, post code 00202, Nairobi
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_Yes
      • number_participantsUpto 150
      • notification<p>\n Please note that since this is a COVID-19-releated study, the ethics approval letter from KEMRI-SERU IRB is still pending as we are making a parallel submission to the committee. We will forward it as soon as we receive it.</p>\n
      • approval_date31-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer concerns have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-10-28 17:40:47
      • created2022-02-25 12:44:48
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id794
        • application_id1120
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
        • professional_addressBox 19464, post code 00202, Nairobi
        • telephone254 733617503
        • emailebukusi@kemri.go.ke
        • created2022-02-25 13:10:39
        • modified2022-03-18 09:45:52
    • SiteDetail(array)
      • 0(array)
        • id1244
        • application_id1120
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-02-25 13:10:39
        • modified2022-03-18 09:45:52
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id578
        • application_id1120
        • sponsorMerck Sharp & Dohme Corp
        • sponsor_typeIndustry
        • contact_person
        • addressPO Box 100, Whitehouse Station, New Jersey, 08889-0100, USA
        • telephone_number1908-740-5633
        • fax_number
        • cell_number1908-740-5633
        • email_addressinfo@msd.com
        • created2022-02-25 13:10:39
        • modified2022-03-18 09:45:52
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $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