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  • 1Recruiting
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    • Application(array)
      • id749
      • user_id484
      • trial_status_id5
      • abstract_of_study<p>\n Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a UNAIDS fast-track and PEPFAR priority country, has an estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90 goal for population-level viral suppression. Feasible, scalable and cost-effective approaches to maximizing durability of 1^st line ART and ensuring viral load (VL) suppression in HIV-infected children are urgently needed. The goal of this pilot study is to determine the feasibility and impact of point-of-care (POC) VL drug resistance mutation (DRM) testing to improve VL suppression in children on 1^st line ART within a PEPFAR-funded HIV care and treatment program in Kenya.</p>\n<p>\n The proposed research is a randomized, controlled study to pilot the use of POC VL, DRM testing, and clinical decision support in children aged 1-14 years on 1^st line ART at three sites with on-site access to GeneXpert technology. Children enrolling at each site will be randomized 1:1 to intervention (POC VL and targeted DRM testing) vs. control (standard-of-care) arms and followed for 12 months. The proposed study will be conducted in PEPFAR-supported HIV treatment facilities in western Kenya, a PEPFAR priority country. This pilot study will evaluate two critical components related to viral suppression in children via: 1) POC VL testing (<strong>Aim 1</strong>) and 2) targeted DRM testing (<strong>Aim 2</strong>) among children on 1^st line ART. Our primary outcome is the proportion of children achieving VL suppression 12 months after POC VL testing implementation, with a secondary outcome of time to viral suppression in those children not suppressed or initiating ART.</p>\n<p>\n This pilot study helps build the foundation for a future adaptive trial which packages optimized POC VL and DRM monitoring algorithms with sociobehavioral behavioral interventions to maximize VL suppression rates in children on 1^st line ART and facilitate timely switch to 2^nd line ART in resource-limited settings. This pilot study will provide critical information on the impact of POC VL testing on viral suppression among children on 1^st line ART in a resource-limited setting. It will additionally show current patterns and impact of DRM testing among children undergoing routine VL monitoring. Findings from this pilot will inform the development of an adaptive clinical trial which evaluates the impact of combination interventions, including POC VL and DRM testing at programmatic scale, facility- and community-based care packages, and the cost-effectiveness of implementing each strategy in achieving viral suppression. This proposal directly addresses the urgent need to find interventions to maximize viral suppression among children on ART and achieve the UNAIDS 90-90-90 goals.</p>\n
      • study_title<p>\n <b><span style=\"font-size: 12pt; font-family: Arial, sans-serif;\">Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids)</span></b></p>\n
      • laymans_summary<p>\n This research will contribute to public health efforts to improve treatment outcomes for children and young adolescents living with HIV on antiretroviral therapy in low-resource settings by evaluating the impact of point-of-care viral load and drug resistance testing and clinical decision support to improve viral suppression and HIV treatment in this population. Findings from this study on improving viral suppression in children will have important implications for HIV care and treatment approaches and guidelines globally. This research has the potential to make important contributions towards addressing some of the key public health problems in sub-Saharan Africa, including attainment of UNAIDS 90-90-90 targets; child morbidity and mortality; and barriers to delivery of key health services.</p>\n
      • short_titleOpt4Kids
      • protocol_noECCT/19/01/02
      • version_no1.0
      • date_of_protocol17-11-2018
      • study_drugNone
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameNo product type, no product in this study.
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspatrickoyaro@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
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      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Patrick Oyaro
      • declaration_date125-01-2019
      • declaration_principal_investigatorDr. Patrick Oyaro
      • declaration_date225-01-2019
      • placebo_presentNo
      • study_objectives<p>\n <strong>Objective 1:</strong> To determine the impact of POC VL on the proportion of children on ART achieving viral suppression and time to viral suppression among those not suppressed or initiating ART (<strong>1a)</strong> and to validate HIV-1 POC VL testing against current in-country gold standard VL testing (<strong>1b</strong>).  </p>\n<p>\n  </p>\n<p>\n <strong>Objective 2:</strong> To determine the impact of targeted DRM testing and patterns of DRMs among children on ART without viral suppression</p>\n<p>\n <strong>Objective 3</strong>: To understand how our intervention functions, by qualitatively exploring the barriers to achieving viral suppression and evaluating the feasibility of incorporating POC VL testing at programmatic scale to overcome of these barriers (<strong>Aim 3a</strong>) and to estimate the costs of implementing pediatric POC VL testing and DRM monitoring and the incremental cost-effectiveness per disability adjusted life year (DALY) averted, compared to standard clinical care (<strong>Aim 3b</strong>).</p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Children age 1-14 years living with HIV (documented HIV positive or HIV viral load)</li>\n <li>\n On anti-retroviral medication (ART) per Kenya National Guidelines </li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Not on antiretroviral treatment and not ready to initaiate treatment.</li>\n</ul>\n
      • primary_end_points<p>\n 1. Viral suppression as defined as viral load <1000 copies/ml at 12 months after study enrollment</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_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyNon-pharmacologic trial. We are testing the impact of laboratory technology, point of care viral load and targeted drug resistance testing, on viral suppression in children with HIV on ART.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Evelyn Brown, Clinical Officer, Study Coordinator</p>\n<p>\n Nashon Onyano, Study Data Manager</p>\n<p>\n Site Coordinators (specific site- TBD)</p>\n<p>\n 1. George Owiti Nursing Officer</p>\n<p>\n 2. Emilly Anyango Clinical Officer</p>\n<p>\n 3. Christine Mule Nursing officer</p>\n<p>\n 4. Mercy Omollo Nursing Officer</p>\n<p>\n 5. Phelix Omondi Nursing Officer</p>\n<p>\n 6. Pauline Achieng’ Clinical Officer</p>\n<p>\n 7. Kezia Tamba Clinical Officer</p>\n<p>\n 8. Lillian Osoo Clinical Officer</p>\n<p>\n  </p>\n<p>\n All sites are operated by the Ministry of Health and are staffed accordingly. All sites provide HIV care with the support of CDC Implementing Partner Family AIDS Care and Education Services (FACES) as per Kenya National HIV Guidelines. Site are well equipped with antiretroviral medications and medicines to treat opportunistic infections including TB. Lab facilities at each site provide basic laboratories and have GeneXpert technology that will be utilized for this study. Kisumu County Director of Health, Dr. Onyango has reviewed and approved this study which also has the support of the County Health Management Team.</p>\n
      • other_details_explanation<p>\n The proposed research investigates optimizing viral suppression among children living with HIV. This research is proposed to take place in Kenya for several reasons.  First, most children living with HIV reside in resource-limited settings, where the burden of HIV is disproportionately high. Therefore, it is only appropriate to conduct such a study in high HIV-burden settings, such as Kenya or other parts of sub-Saharan Africa. Furthermore, we are conducting this study within a region of Kenya with the highest prevalence and burden of pediatric HIV within Kenya. Second, the study is more feasible to conduct in Kenya than, for example, in the US, because both the prevalence of HIV and the lack of viral suppression are more common in Kenya than in the US. Third, we are proposing this research in the context of existing research and programmatic work already underway in Kisumu, Kenya. Therefore, leveraging the considerable resources for the study site to conduct the proposed study is crucial for feasibility. For all these reasons, conducting this research in Kenya is the most appropriate, feasible, and timely way to answer the proposed research questions.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Note, all study sites are in Kenya</p>\n<p>\n AMREF 27th November 2018</p>\n<p>\n Univerity of Washington 1st June 2018</p>\n<p>\n University of Colorado 2nd Oct 2018</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRoutine viral load assay
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sitesFive
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteApproximately 175
      • total_participants_worldwide700
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • 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_specifyChildren under the age of 18. Concsent given by their caregivers
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameRena
      • investigator1_middle_name
      • investigator1_family_namePatel
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressUniversity of Washington
      • investigator1_telephone12065203811
      • investigator1_emailrcpatel@uw.edu
      • organisations_transferred_Yes
      • number_participants700
      • notification
      • approval_date15-03-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Feasible, scalable, and cost  effective approaches to ensure virological suppression among children living with HIV are urgently needed. The aim of the Opt4Kids study was to determine the effect of point of care viral load and targeted drug resistance mutation testing in improving virological supression among children on antirestroviral therapy in kenya.</p>\n<p>\n In this open-label, individually randomised controlled trial, we enrolled children living with HIV aged 1-14 years and who were either newly initiating or already receiving ART at five study faicitlities in Kenya. participants were randomly llocated 1:1 to recieve the intervention of point-of-care viral load testing every 3 months, targeted drug resistance mutation testing and clinical decision support (point of care testing) or to receive the standard of care (control group), stratified by facility site and age groups (1-9 years vs 10-14 years). Invesstigators were masked to the randmised group. The primary efficacy outcome was voirological supprrsssion (defined as a viral load of <1000 copied per mL) by point of care viral load testing at 12 months after enrollment in all participants with an assessment. This study was registered with ClinicalTrials.gov. NTCT03820323. </p>\n<p>\n The study ended amidst the challenges of the COVID-19 pandemic which affected the speed of impementaton and occasional lack of viral reagents within the government health facilities. The primary outcome results have been published at the Lancet journal.</p>\n
      • implication_results<p>\n From the study we found that point-of-care viral load testing decreased turnaround time and targeted drug resistance mutation testing identified a high prevalence of HIV drug mutations in children living with HIV but with combined approach did not increase rates of virological suppression. This information is important for the public health departments to consider the scale of point-of care viral load testing to fast track availability of results for patient management. Further research in combination interventions, including point-of-care viral load and drug resistance mutation testing couples with psychological support, is needed to optimize viroligical suppression for children living with HIV.</p>\n
      • quantity_importedN/A
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exportedN/A
      • balance_siteN/A
      • final_date0000-00-00
      • modified2022-10-17 07:47:08
      • created2019-01-15 11:14:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id467
        • application_id749
        • given_nameLisa
        • middle_nameDillabaugh
        • family_nameAbuogi
        • qualificationMD, MS
        • professional_addressUniversity of Colorado
        • telephone13033585061
        • emailLisa.Abuogi@childrenscolorado.org
        • created2019-01-15 11:20:56
        • modified2020-02-28 15:44:18
      • 1(array)
        • id468
        • application_id749
        • given_namePatrick
        • middle_nameOyaro
        • family_nameOwiti
        • qualificationMBChB, MPH
        • professional_addressMilimani. P.O. Box 943 - 40100 Kisumu , Kenya
        • telephone+254 721 245564
        • emailpatrickoyaro@gmail.com
        • created2019-01-15 19:54:34
        • modified2020-02-28 15:44:18
    • SiteDetail(array)
      • 0(array)
        • id590
        • application_id749
        • county_id42
        • site_nameKisumu County Hospital
        • physical_addressKisumu East Sub County
        • contact_detailsP.O.Box 1818 code 40100Kisumu
        • contact_personMolly Oloo Phone number 0722356502
        • site_capacity(null)
        • misc(null)
        • created2019-01-15 11:20:56
        • modified2020-02-28 15:44:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id591
        • application_id749
        • county_id42
        • site_nameAhero County Hospital
        • physical_addressNyando Sub-County
        • contact_detailsP.O.Box 169 code 40101 Ahero
        • contact_personBenard Owino Phone number 0702769492
        • site_capacity(null)
        • misc(null)
        • created2019-01-15 11:29:00
        • modified2020-02-28 15:44:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id592
        • application_id749
        • county_id42
        • site_nameNyakach County Hospital
        • physical_addressNyakach Sub-County
        • contact_detailsP.O.Box 79 code 40111 Pap Onditi
        • contact_personDr Agwanda A. Phone number 0726654252
        • site_capacity(null)
        • misc(null)
        • created2019-01-15 11:29:00
        • modified2020-02-28 15:44:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 3(array)
        • id701
        • application_id749
        • county_id42
        • site_nameLumumba sub-County Hospital
        • physical_addressAlong James Agoi Road
        • contact_detailsP. O Box 486 - 40100
        • contact_personSamuel Ochieng
        • site_capacity(null)
        • misc(null)
        • created2020-02-28 15:40:40
        • modified2020-02-28 15:44:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id702
        • application_id749
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressAlong Kisumu - Kakamega Road
        • contact_detailsP. O Box 849 - 40100
        • contact_personDr. Okoth
        • site_capacity(null)
        • misc(null)
        • created2020-02-28 15:40:40
        • modified2020-02-28 15:44:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id364
        • application_id749
        • sponsorNational Institute of Mental Health
        • sponsor_typeResearch Institution
        • contact_personJohn E. Fonda
        • addressNational Institute of Mental Health Office of Science Policy, Planning, and Communications 6001 Executive Boulevard, Room 6200, MSC 9663 Bethesda, MD 20892-9663
        • telephone_number1301-402-8158
        • fax_number
        • cell_number1301-402-8158
        • email_addressjohn.fonda@nih.gov
        • created2019-01-15 11:20:56
        • modified2020-02-28 15:44:18
  • 1(array)
    • Application(array)
      • id746
      • user_id611
      • trial_status_id3
      • abstract_of_study<p>\n Plasmodium falciparum (P. falciparum) malaria remains a deadly endemic parasitic disease, with 212 million new cases and over 429,000 deaths reported in 2015. World Health Organization (WHO) guidelines recommend that artemisinin-based combination therapies (ACT) are used to treat uncomplicated P. falciparum malaria, which is administrated in a 3-day regimen. Sanofi and Medicines for Malaria Venture (MMV) are co-developing a fixed dose combination (FDC) of FQ and artefenomel (OZ439) for a single dose treatment of uncomplicated malaria in adults and children. Per Food and Drug Administration (FDA) guidance for co-development of 2 new investigational drugs for use in combination, it is recommended to demonstrate the contribution of each individual component to the effect of the combination. This phase 2a study will test clinical and parasiticidal activity, pharmacokinetics (PK) and safety of 3 doses of OZ439 associated with a fixed dose of FQ and FQ alone. This is a phase 2a, randomized, open label, parallel-group study, single-dose regimen, testing 3 dose levels of OZ439 given in combination with FQ and FQ alone in participants with uncomplicated P. falciparum malaria. The primary objective of the study is to show the contribution of OZ439 to the clinical and parasiticidal effect of OZ439/FQ combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the concentration time curve up to infinity (AUC) of OZ439 as PK predictor. Adults up to 69 years old and adolescents as of 14 years old will be included in 4 parallel arms in a 1:1:1:1 randomization ratio. Randomization will occur the day of or up to 1 day after screening procedures. Participants will receive one of the 4 treatments: FQ 400 mg alone or combined with OZ439 300 mg, 600 mg, or 1000 mg. Participants will be hospitalized for the first 48 hours or up to 4 days or longer upon investigator’s judgment. Participants will be screened sequentially as they present to the study facility to achieve 140 randomly assigned to study treatment and 120 evaluable participants for an estimated total of 30 evaluable participants per treatment group. Ahero site we will recruit about 40 patients both males and females. There will be 4 study groups receiving different doses of study drugs. The primary endpoint will be Day 28 PCR-corrected ACPR. The parasite clearance will be determined by microscopy and PK parameters will determined by chromatography techniques while safety parameters will be assessed by clinical evaluation during the study visits and clinical laboratory evaluations.</p>\n
      • study_title<p>\n A Randomized, Open label, Parallel-group, Single Dose Regimen, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 dose levels of Artefenomel (OZ439) given in combination with Ferroquine (FQ) and FQ alone, in African Patients with Uncomplicated Plasmodium falciparum Malaria</p>\n
      • laymans_summary<p>\n Malaria remains a major public health with great impact on children and pregnant women. In 2015 World health Organization reported 212 million new cases and over 429,000 deaths. WHO currently recommends the use of artemisinin-based combination treatment (ACT) for uncomplicated <em>P. falciparum </em>malaria, administrated in a 3-day dose. However, there is already development of resistance to ACTs in South East Asia and there is worry that this will spread the rest of the world and there is need to develop new combinations treatment regimens for treatment of uncomplicated malaria. Therefore, Sanofi and Medicines for Malaria Venture (MMV) are co-developing a fixed dose combination (FDC) of FQ and artefenomel (OZ439) for a single dose treatment of uncomplicated malaria in adults and children. The study is going to be done in several countries where malaria is common and Kenya is one of them. The sample size will be140 patients with uncomplicated malaria. In Kenya the study will be conducted in Ahero and Siaya County hospitals. In Ahero we will recruit about 40 patients both males and females. The patients will have blood drawn from the arm to check the presence parasites in the blood, check the blood level, kidney, liver functions and drug blood level. The main outcome will be clearance of parasites and no recurrence of infection by 28 days after starting treatment. The potential risks are that this is a new drug and a patient can react to it but so far it has been safe in the previous studies. The other possible risks is that being a new it may not clear malaria infection but the patients will be followed up closely and in case of failure to respond to treatment they will be given rescue treatment. The study will be conducted in line with National and international guidelines for clinical trials. The study will be initiated once all the approvals have been obtained and the sponsor representatives initiates the study site. The data generated will be analysed as per the predesigned statistical analytical plan and will focus on the how well the drug clears malaria parasites from the patients’ blood, how the drug is safe and drug level in the patients’ blood. The results from this study will inform the development of this new treatment of uncomplicated malaria that is needed as there is already resistance to ACTs in Asia. The results from this study will be disseminated to stakeholders in Kisumu County, published in peer reviewed scientific journals, presented at Scientific conferences.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleA Randomized, Open, Parallel-group, Single Dose, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 dose levels of Artefenomel in combination with Ferroquine (FQ) and FQ alone, in African Patients with Unc
      • protocol_noECCT/19/01/01
      • version_noVersion number: 1
      • date_of_protocol13-11-2017
      • study_drugOZ439 (artefenomel) and SSR97193 (ferroquine)
      • disease_conditionPlasmodium falciparum (P. falciparum) malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid1
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameOZ439 and SSR97193
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressMshitindo@strathmore.edu
      • 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_countries1
      • applicant_addendum1
      • applicant_fees1
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      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantAMINA SALIM
      • declaration_date116-01-2019
      • declaration_principal_investigatorBERNHARDS OGUTU - PRINCIPAL INVESTIGATOR
      • declaration_date216-01-2019
      • placebo_presentNo
      • study_objectives<p>\n Primary</p>\n<p>\n  </p>\n<ul>\n <li>\n To show the contribution of OZ439 to the clinical and parasiticidal effect of OZ439/FQ combination by analyzing exposure-response of OZ439 measured by Day 28 PCR-corrected ACPR for the effect and the AUC of OZ439 as PK predictor</li>\n</ul>\n<p>\n  </p>\n<p>\n Secondary</p>\n<p>\n  </p>\n<ul>\n <li>\n To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day 28 ACPR</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints </li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n To evaluate the safety and tolerability of different dosages of OZ439 in combination with FQ and FQ alone</li>\n</ul>\n<p>\n  </p>\n<p>\n To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213 in blood</p>\n<p>\n  </p>\n<p>\n Tertiary/exploratory</p>\n<p>\n  </p>\n<ul>\n <li>\n To explore the impact of study treatment on functional gametocytemia</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n To evaluate the relationship between parasitemia and concentration of OZ439/FQ</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n To evaluate the relationship between QTc and concentration of OZ439/FQ</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n 11.0 INCLUSION CRITERIA Participants are eligible to be included in the study only if all of the following criteria apply: Age Participant must be 14 to 69 years of age inclusive, at the time of signing the informed consent. Type of participant and disease characteristics 1. Participants who present with uncomplicated P. falciparum malaria, with a fever as defined with axillary temperature ≥37.5 degree Celsius (°C) or oral/ rectal/ tympanic temperature ≥38°C or history of fever in the previous 24 hours (history of fever must be documented), with a mono-infection with P. falciparum and parasitemia (microscopically, blood smear) ≥3,000 and ≤50,000 asexual parasites/μL of blood. Weight Body weight within 35 and 90 kg (inclusive). Sex Male and female 1. Male participants: A male participant must agree to use contraception as detailed in Appendix 5 of this protocol for 3 months after the last dose of study treatment and refrain from donating sperm during this period. 2. Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least one of the following conditions applies: - Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 OR - A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 for 3 months after the last dose of study treatment. Informed Consent Capable of giving signed informed consent (if the patient is ≥age defining majority) as described in Appendix 3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Informed consent signed by the legally acceptable representative (LAR) of the minor patient (<18 years of age or</p>\n
      • principal_exclusion_criteria<p>\n 12.0 EXCLUSION CRITERIA Participants are excluded from the study if any of the following criteria apply: Medical conditions 1. Presence of severe malaria 2. Known history or evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, respiratory, endocrine, immunological, infectious, neurological (in particular convulsions), malignancy, psychiatric disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety information. 3. Severe vomiting defined as more than 3 times in the 24 hours prior to enrollment in the study or inability to tolerate oral treatment or severe diarrhea defined as 3 or more watery stools per day Severe malnutrition defined as body mass index of less than 16 kg/m² for adults and for children Z-score <-3 or weight for age (%) of the median <60. 4. Splenectomized participants or presence of surgical scar on left hypochondrium 5. Known history of hypersensitivity, allergic, or anaphylactoid reactions to FQ or other amino quinolines or to OZ439 or OZ277 or any of the excipients. Prior/concomitant therapy Participant treated with anti-malarial treatment: 1. With PQP-based compound, mefloquine, naphthoquine or sulphadoxine/pyrimethamine within the previous 6 weeks. 2. With amodiaquine or chloroquine within the previous 4 weeks. 3. With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial 4. treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days. 5. With any herbal products or traditional medicines, within the past 7 days 6. Previous treatment within 5 times the half-life or within the last 14 days, whichever the 7. longest, which are: strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but 8. inhibiting both CYP2C and CYP3A and/or CYP inducers (Appendix 6). Any treatment known to induce a prolongation of QT interval (Appendix 6) Prior/concurrent clinical study experience 1. Participated in any trial investigating OZ439 and/or FQ compounds 2. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance 3. Enrolled in another clinical trial within the past 4 weeks or during the study period Diagnostic assessments 1. Mixed Plasmodium infection 2. Presence of Hepatitis A – immunoglobulin M (HAV-IgM), Hepatitis B surface antigen 3. (HBs Ag) or Hepatitis C virus antibody (HCV Ab) and/or known to have active Hepatitis 4. C virus RNA (HCV RNA) 5. Laboratory parameters with abnormalities deemed clinically significant by the investigator. 6. Abnormal LFT: aspartate transferase (AST) >2 upper limit of normal range (ULN), or alanine transferase (ALT) >2 ULN or total bilirubin >1.5 ULN 7. Positive pregnancy test at study screening for female participants of childbearing potential 8. QTcF >450 ms at screening or pre-dose 9. Hypokalemia (<3.5 mmol/L), hypocalcemia (<2.0 mmol/L) or hypomagnesemia (<0.5 mmol/L) at screening or pre-dose Other exclusions 1. Family history of sudden death or of congenital prolongation of the QT interval or known congenital prolongation of the QT-interval or any clinical condition known to prolong the QT interval e.g., participants with a history of symptomatic cardiac arrhythmias including atrial fibrillation (AF) or with clinically relevant bradycardia 2. Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures or unable to drink.</p>\n
      • primary_end_points<p>\n 13.0 PRIMARY END POINTS. • To show the contribution of OZ439 to the clinical and parasiticidal effect of OZ439/FQ combination by analyzing exposure-response of OZ439 measured by Day 28 PCR-corrected ACPR for the effect and the AUC of OZ439 as PK predictor. • Day 28 PCR-corrected ACPR.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 19.0 CAPACITY OF AHERO SITE NO NAME ROLE</p>\n<p>\n 1 Dr. Bernhards Ogutu PI (MBChB, MMED ,PhD)</p>\n<p>\n 2 DR. John Michael Ongecha Sub I (MSc ,PhD Immunology)</p>\n<p>\n 3 Dr. Fredrick Olewe Sub I (MBChB)</p>\n<p>\n 4 Nelly Koskei Clinical Research Coordinator</p>\n<p>\n 5 Agnes Onyango Nurse</p>\n<p>\n 6 Maureen Mbija Nurse</p>\n<p>\n 7Mary Atieno Nurse</p>\n<p>\n 8 Jael Aran Nurse</p>\n<p>\n 9 Wycliff Misiayi Nurse</p>\n<p>\n 10 Winny Chepkemoi Clinical Officer</p>\n<p>\n 11 Hellen Nyangasi Clinical Officer</p>\n<p>\n 12 Solomon Otieno Clinical Officer</p>\n<p>\n 13 Kennedy Ogweno Laboratory Technologist</p>\n<p>\n 14 Festus Okute Microscopist</p>\n<p>\n 15 Grace Owino Laboratory Technologist</p>\n<p>\n 16 Cornel Arima Laboratory technologist</p>\n<p>\n 17 Dr. Ruth Wasuna Pharmacist</p>\n<p>\n 18 Mathew onyango Pharmaceutical technologist</p>\n<p>\n 19 Fredrick Otieno Field Coordinator</p>\n<p>\n 20 Florence Amollo Community Health Worker</p>\n<p>\n Ahero Clinical trials Unit is situated within Ahero County Hospital. It has a 7 bed capacity ward for study participants, Laboratory and pharmacy. There is an emergency tray within the wards. All participants who need further medical attention are referred to Jaramogi Oginga Odinga teaching and Referral Hospital.</p>\n
      • other_details_explanation<p>\n Europe is a non-endemic Malaria zone. There are only imported malaria cases in Europe. In France, 3,560 imported cases were reported in 2011.Source: https://www.pasteur.fr/en/medical-center/disease-sheets/malaria</p>\n<p>\n France is a non-endemic malaria zone. WHO report (2016): http://apps.who.int/iris/bitstream/10665/254913/1/WHO-HTM-GMP-2017.4-fre.pdf?ua=1</p>\n
      • other_details_regulatory_notapproved<p>\n Uganda submitted to NDA 11 December 2018, outcome pending</p>\n
      • other_details_regulatory_approved<p>\n The Scientific and Ethics Review Unit (SERU) - KEMRI</p>\n
      • other_details_regulatory_rejected<ol>\n <li>\n Benin submitted 15 February 2018, Approval 25 Sept 2018 (1 site)</li>\n <li>\n Burkino-Faso – 16 April 2018, approved 25 May 2018 (2 sites)</li>\n <li>\n Gabon submitted 14 June 2018, approved 19 June 2018 (2 sites)</li>\n <li>\n Kenya submitted 17 May 2018, approved 03 October 2018 (1 site – Dr Kaguthi)</li>\n</ol>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration1 Year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNot applicable
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites2
      • multi_country_listBenin, Gabon, Kenya, Uganda, Burkina Faso
      • data_monitoring_committeeYes
      • total_enrolment_per_site40 (Ahero)
      • total_participants_worldwide140
      • population_less_than_18_yearsYes
      • 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_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_nameBernhards
      • investigator1_middle_nameOgutu
      • investigator1_family_nameRagama
      • investigator1_qualification MBChB, MMED, PhD
      • investigator1_professional_addressP.O. BOX 54 KISUMU
      • investigator1_telephone+254 733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_No
      • number_participants40 (Ahero)
      • notification
      • approval_date13-08-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-01-19 16:57:39
      • created2019-01-07 11:14:08
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id466
        • application_id746
        • given_nameBernhards
        • middle_nameOgutu
        • family_nameRagama
        • qualificationMBChB, MMED, PhD
        • professional_addressP.O. BOX 54 KISUMU
        • telephone+254 733812613
        • emailogutu6@gmail.com
        • created2019-01-07 11:46:21
        • modified2020-05-13 16:57:58
    • SiteDetail(array)
      • 0(array)
        • id588
        • application_id746
        • county_id42
        • site_nameAhero County hospital
        • physical_addressNext To Ahero Police Station, Along Kisumu - Busia Road, Ahero
        • contact_details+254727863357/ 737183162
        • contact_personFred Olewe
        • site_capacity(null)
        • misc(null)
        • created2019-01-07 11:46:21
        • modified2020-05-13 16:57:58
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id589
        • application_id746
        • county_id41
        • site_nameSiaya County Hospital
        • physical_addressn/a
        • contact_detailsn/a
        • contact_personn/a
        • site_capacity(null)
        • misc(null)
        • created2019-01-07 12:25:59
        • modified2020-05-13 16:57:58
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id363
        • application_id746
        • sponsor Sanofi-Aventis R&D
        • sponsor_typeIndustry
        • contact_personTherese Sylvester
        • addresssanofi-aventis South Africa (Pty) Ltd Sanofi House, 44 on Grand Central Office Park, 2 Bond Street, Grand Central Extension 1, Midrand 1685
        • telephone_number+1.330.278.9251
        • fax_numberN/A
        • cell_number+1.330.278.9251
        • email_addresstsylvester@icongphs.com
        • created2019-01-07 11:46:21
        • modified2020-05-13 16:57:58
  • 2(array)
    • Application(array)
      • id745
      • user_id691
      • trial_status_id8
      • abstract_of_study<p>\n Malnutrition is a major public health problem worldwide. More than 250 million children less 121 than 5 years of age are underweight, stunted or wasted. Malnourished children need diets that 122 provide necessary nutrients, for growth and development. Currently Corn-Soy flour Blend 123 (CSB) fortified blended flour commonly used in treating moderate acute malnutrition (MAM) 124 favour large intake of omega 6 and negligible omega 3 fatty acids. Long chain Omega 3 fatty 125 acids are anti-inflammatory and effective in treating some inflammatory disorders. This MAMI RCT VERSION 1.1 NOV 2016 Page 6 126 proposal seeks to study how adding fish oil to CSB affects the systemic inflammation and 127 other clinical outcomes of the malnourished children child. We propose to carry out the work 128 in Kibera slum in Nairobi County. The project has potential to provide valuable information 129 that can change policy on management of acute moderate malnutrition</p>\n
      • study_title<p>\n Randomized Controlled Trial to Compare the Effect of Corn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO) on 9 the Immunological and Microbiota Patterns among Children Aged 6 to 24 months with 10 Mod</p>\n
      • laymans_summary(null)
      • short_titleRandomized Controlled Trial to Compare the Effect of Corn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO) on 9 the Immunological and Microbiota Patterns among Children Aged 6 to 24 months with 10 Mod
      • protocol_noECCT/18/12/02
      • version_no1.1
      • date_of_protocol01-11-2016
      • study_drugCorn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO)
      • disease_conditionMALNUTRITION
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameCorn-Soy Blend + Vegetable Oil 8 and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO)
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressezekiel.muinde@yahoo.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantEZEKIEL MUINDE
      • declaration_date114-12-2018
      • declaration_principal_investigatorDR PHELGONA A. OTIENO
      • declaration_date214-12-2018
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion criteria:</p>\n<p>\n 382 ï‚· Resident and living within Kibera Slums in Nairobi for the duration of the study 383 ï‚· Aged 6 - 24 months with MAM, defined as weight-for-length z-score (WLZ) between 384 -3 to -2 and/or mid-upper arm circumference (MUAC) of 11.5 to < 12.5cm. 385 ï‚· Caregiver is able and willing to provide informed consent.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria:</p>\n<p>\n 388 ï‚· Severe acute malnutrition (SAM) WLZ< -3 and/or MUAC < 11.5 cm 389 ï‚· Chronic malnutrition: Length-for-age z-score (LAZ)<-2 390 ï‚· Severe anemia Hb < 6 gm/dl 391 ï‚· Other chronic illnesses such as AIDS, TB or malignancy 392 o HIV test positive by Determine and Unigold rapid test kits. If the child is <12 393 months PCR testing will be conducted to determine HIV status. 394 o History of TB or malignancy 395 ï‚· Active infections in the past two weeks such as: Pneumonia, Gastroenteritis, Urinary 396 tract infections or Meningitis ï‚· Temperature >37.50 397 C 398 ï‚· Gross Congenital abnormalities</p>\n
      • primary_end_points<p>\n a) To determine the effect of Corn-Soy Blend plus fish oil (CSB-VO-FO) compared to 718 standard-of-care [Corn-Soy Blend plus vegetable oil (CSB-VO)] on level of expression of 719 inflammatory markers in children with MA.</p>\n<p>\n b) To determine recovery and growth rates among moderately malnourished children 729 receiving either CSB-VO-FO or CSB-VO as supplementary food. 730 MAM recovery rate: The percent of children who attain normal nutrition status within a 731 period of 12 weeks will be compared between the two intervention arms.</p>\n<p>\n c) To determine the effect of Corn-Soy Blend, vegetable oil plus fish oil (CSB-VO-FO) 736 compared to standard-of-care [Corn-Soy Blend plus vegetable oil (CSB-VO)] in the 737 composition of the fecal microbiota.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence1
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Beatrice Olack: Is a Co-Principal Investigator who has been involved in proposal 840 development. She is the contact person for the project and will be involved in study 841 Coordination. She will continue in application for grants and be involved in nutritional 842 aspects of the study including development of SOPS, nutrition counseling and nutrition 843 therapy. She will also be responsible for training of research assistants on anthropometry and 844 nutrition counseling. She will also be involved in manuscript writing </p>\n<p>\n Dr. Margaret Mbuchi: Is a co-Investigator who has been actively involved in the protocol 846 development especially on the laboratory methods of the study. She will be responsible in 847 overseeing all the laboratory activities of the study including leukocyte stimulation with 848 various pathogens and preparation for RNA extraction for further tests. She will organize the 849 exportation of specimens to UTMB as required. Dr. Mbuchi will also be involved in 850 manuscript writing.</p>\n<p>\n 851 Dr. Mary I. Matilu: Dr. Matilu has contributed to protocol development. She will be 852 involved in developing SOPS and other study tools. She is core for clinical activities of the 853 study. She will also participate in training study staff on clinical aspects of the study. She will 854 also be involved in implementations of the study by overseeing the clinical activities for the 855 study. Dr. Mary will also be involved in manuscript writing</p>\n<p>\n 856 Rukia Kibaya: Is a co-Investigator who has been actively involved in the protocol 857 development especially on the laboratory methods of the study. She will be involved in 858 specimen handling to ensure quality at all levels as well as conduct of various tests required 859 for the project. Rukia will also be involved in manuscript writing</p>\n<p>\n Dennis Kivuva: Is a Co-Investigator who has been actively involved in protocol 861 development. He will be involved in data collection as well as nutritional components of the 862 study such as developing SOPs and anthropometric measurements.</p>\n<p>\n 863 Christine McGrath: Is a Co-Investigator who has been actively involved in proposal 864 development. She will be involved in advice on various approaches for data analysis and 865 manuscript writing. 866</p>\n<p>\n Thaddaeus Egondi: He is the Biostatistician for the project. He will be involved in 867 developing the statistical plan for the study as well as develop database and running data 868 analysis for the study in conjunction with the rest of the team. 869</p>\n<p>\n Bernhard Ogutu: Is a Co-Investigator who has been actively involved in proposal 870 development. He will be involved in advice on various approaches for study implementation 871 and analysis as well as manuscript writing.</p>\n<p>\n 872 Linet Ouma: Is a Co-Investigator who has been actively involved in proposal development. 873 She will be the involved in data collection SOP development, coordination of field activities 874 and manuscript writing.</p>\n
      • other_details_explanation
      • 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_duration20 weeks
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator Corn-Soy Blend + Vegetab
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKENYA MEDICAL RESEARCH INSTITUTE
      • single_site_physical_addressCENTER FOR CLINICAL RESEARCH- CCR
      • single_site_contact_personDR PHELGONA A. OTIENO
      • single_site_telephone0721973971
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_sitesample size of 40 subjects per group will have 80% power to detect a 20% reduction
      • total_participants_worldwide40
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyTHE PARTICIPANTS ARE CHILDREN UP TO 24 MONTHS
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePHELGONA
      • investigator1_middle_nameAPONDI
      • investigator1_family_nameOLANDO
      • investigator1_qualificationMBCHb
      • investigator1_professional_addressKEMRI
      • investigator1_telephone0721973971
      • investigator1_emailphelgona@gmail.com
      • organisations_transferred_No
      • number_participants40
      • notification
      • approval_date25-02-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-12-2018
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-03-31 09:43:24
      • created2018-12-10 11:31:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id465
        • application_id745
        • given_nameCHRISTOPHER L. MELBY
        • middle_name
        • family_nameMELBY
        • qualificationdoctor of public health
        • professional_addressDepartment of Food Science and Human Nutrition Nutrition and Metabolic Fitness Laboratory 226 Gifford Building Colorado State University Fort Collins, Colorado 80523
        • telephonePhone: Office- (970)-491-6736; Lab-(970)-491-3373
        • emailchris.melby@colostate.edu
        • created2018-12-17 08:19:47
        • modified2018-12-17 10:08:02
    • SiteDetail(array)
      • 0(array)
        • id587
        • application_id745
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-12-17 08:19:47
        • modified2018-12-17 10:08:02
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id362
        • application_id745
        • sponsorKENYA MEDICAL RESEARCH CENTER
        • sponsor_type(null)
        • contact_personDR PHELGONA A. OTIENO
        • addressP.O. Box 54840 00200 Off Mbagathi Road, Nairobi, Kenya.
        • telephone_numberTel:+254 020 2713349 / +254 020 2722541 / 0722-205901
        • fax_number
        • cell_numberTel:+254 020 2713349 / +254 020 2722541 / 0722-205901
        • email_addressINFO@KEMRI.ORG
        • created2018-12-17 08:19:47
        • modified2018-12-17 10:08:02
  • 3(array)
    • Application(array)
      • id726
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n In the era of anti-malaria drug resistance and resistance to insecticide treated bed nets, there is an urgent need for a highly efficacious vaccine. We plan to evaluate a candidate malaria vaccine incorporating the antigen R21 (part of the P. falciparum circumsporozoite malaria antigen co-expressed with hepatitis B antigen) plus an adjuvant to boost the immune responses (Matrix-M). R21c/MM showed promising safety and immunogenicity data in preclinical and early phase trials in Oxford. We will conduct an open label, age de-escalation, dose escalation study in 20 healthy adults (18-45 years), 20 young children aged 1-5 years and 51 infants aged 5- <12 months. Each participant will be screened to ensure they are in good health based on clinical assessment and laboratory results. Participants will have a blood test to ensure suitability prior to vaccination. For each participant, there will be a total of 31 visits to the clinic and at home, 15 of which will be associated with blood sampling. Participants will receive 3 vaccinations 4 weeks apart. Blood tests and clinical assessments will be conducted to screen out participants with health conditions that may impact participation in the study. Bloods will be taken at screening and a day prior to enrolment. Blood will also be taken prior to each vaccination and on days 2 and 7 post vaccination at the clinic. Home visits will be made on days 1, 3, 4, 5, and 6 to identify solicited adverse events. Bloods for immunology will be taken prior to vaccination, and throughout the study to assess the immune response to R21/MM. Should the vaccine be safe and immunogenic this trial is part of a programme of work that aims to develop a multi-stage malaria vaccine (R21 would be one component) that could provide very high rates of protection in the most vulnerable age groups in an endemic setting. Participants will have extended follow-up for 2 years following final vaccination to determine the longevity of the immune response.</p>\n
      • study_title<p>\n A Phase 1b, open-label, age de-escalation, dose-escalation study to evaluate the safety and immunogenicity of different doses of a candidate malaria vaccine; adjuvanted R21(R21/MM) in adults, young children and infants in Kilifi, Kenya.</p>\n
      • laymans_summary<div>\n <strong>Lay Title</strong>: A study to determine if a new malaria vaccine is safe and induces immunity among</div>\n<div>\n Kenyan adults, young children and infants.</div>\n<div>\n <strong>What is the problem/background?</strong></div>\n<div>\n RTS,S/AS01, is the only malaria vaccine in advance clinical development but could be better by</div>\n<div>\n preventing malarial infection particularly in vaccinated infants and is being evaluated for use in the</div>\n<div>\n infant vaccine schedule recommended by the World Health Organisation as well as determining the</div>\n<div>\n significance of any safety concerns. There are several thoughts as to why RTS, S may not prevent</div>\n<div>\n more clinical infections; Only a small proportion of the vaccine is made up of Malaria parasite</div>\n<div>\n protein, in our candidate vaccine the particle is coated with malaria parasite protein. Another</div>\n<div>\n hypothesis is that the majority of RTS, S/AS01 is composed of a Hepatitis B surface protein which</div>\n<div>\n may interfere with the immune response in infants, R21/MM has very little of this protein on its</div>\n<div>\n surface. R21/MM also induces a good immune response, is cheap and easy to make and as such</div>\n<div>\n there is a good case for further clinical development of this vaccine. Malaria deaths have fallen with</div>\n<div>\n the advent of new drug combinations and widespread use of insecticide treated bed nets but the hope</div>\n<div>\n malaria eradication is threatened by emerging resistance to these drugs and insecticides. One of the</div>\n<div>\n primary strategic goals outlined by WHO in the Malaria Vaccine Roadmap, is the development of</div>\n<div>\n malaria vaccines which would protect against clinical malaria in 3 out of 4 vaccinated individuals,</div>\n<div>\n and would be suitable for administration in malaria endemic areas and appropriate at-risk groups by</div>\n<div>\n 2030. R21/MM is a candidate malaria vaccine and biologically similar to RTS,S/AS01 and RTS,S</div>\n<div>\n has been evaluated extensively in clinical trials. R21 has had 3 formulations to date; R21, R21c and</div>\n<div>\n now R21/MM. R21 that was evaluated in animal studies then in an effort to progress to clinical trials,</div>\n<div>\n purification of the vaccine was required and this was challenging hence components of a protein</div>\n<div>\n were added to R21 making R21c which was manufactured in Oxford, UK. R21c has been evaluated</div>\n<div>\n in animal and human trials but to move forward in clinical development a large-scale manufacturer</div>\n<div>\n was required and the current vaccine (R21/MM) has been subjected to some minor changes. These</div>\n<div>\n products (R21/R21c and R21MM) are all very similar but R21/MM has yet to be evaluated in human</div>\n<div>\n subjects. The main difference being R21/MM does not have 4 components of a protein, the c-tag</div>\n<div>\n which was present in R21c. Also, each vaccine has a different manufacturer, however we do not anticipate the immune response or safety profile to change given the removal of this protein</div>\n<div>\n component or the new manufacturer. Matrix-M is a component of the vaccine that has been</div>\n<div>\n demonstrated to improve vaccine response of R21c and to be safe in healthy adults.</div>\n<div>\n <strong>What questions are we trying to answer?</strong></div>\n<div>\n We plan to evaluate if R21/MM, a candidate malaria vaccine, is safe and provides good vaccine</div>\n<div>\n responses at different doses in healthy Kenyan adults (aged 18-45 years), young children (aged 1-5</div>\n<div>\n years) and infants (5-<12 months) and investigate the immune responses following vaccination and</div>\n<div>\n the persistence of these in the first 2 years following a 3- dose vaccination course, given 4 weeks</div>\n<div>\n apart.</div>\n<div>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></div>\n<div>\n The study is taking place in Kilifi County (Pingilikani and Junju) dispensaries as well as KEMRIWellcome</div>\n<div>\n Trust outpatient departments and we will recruit healthy participants. This study will</div>\n<div>\n evaluate the safety and vaccine responses of R21/MM in 20 adults, 20 young children and 51 infants.</div>\n<div>\n We will screen potential participants until we identify the required number of healthy participants</div>\n<div>\n from the different age groups.</div>\n<div>\n <strong>What does the study involve for those who are in it?</strong></div>\n<div>\n For individuals who are screened for potential participation, 5- 9mls of blood will be drawn at the</div>\n<div>\n different time-points (maximum of 5mls for infants and young children, 9 mls for adults per visit).</div>\n<div>\n For participants enrolled be the maximum blood samples taken per visit will be 5 mls for infants,</div>\n<div>\n 10mls for young children and 30 mls for adults. Recruited infants will have an average of 66mls</div>\n<div>\n taken, young children 121mls and adults 351mls over 2 year and 5 months which will be within the</div>\n<div>\n limits stipulated by the World Health Organisation. Repeat blood samples may be taken to verify</div>\n<div>\n abnormal results. Medical history will also be obtained and a clinical assessment including a check of</div>\n<div>\n the functioning of the heart. For children oxygen levels and listening to the heart will serve as an</div>\n<div>\n assessment of heart function, for adults a test will be conducted to assess the baseline function of the</div>\n<div>\n heart, and to exclude any significant heart problems. Those that pass screening, will be enrolled in</div>\n<div>\n the trial. Blood will be taken at screening, a day prior to enrolment, prior to each vaccination, 2 days</div>\n<div>\n and 7 days post each vaccination, 28 days post the 3rd vaccination and at 6, 12 and 24 months post</div>\n<div>\n the 3rd vaccine dose. There will be a total of 31 visits, 15 of which will be conducted at home. The</div>\n<div>\n study duration for each participant will be a minimum of 2 years and 5 months.</div>\n<div>\n <strong>What are the benefits and risks/costs of the study for those involved?</strong></div>\n<div>\n Participants may benefit from receipt of the vaccine if we demonstrate that the immune response in a</div>\n<div>\n Kenyan population is favourable and the vaccine is safe. Participants will also have close oversightand treatment support from the study team although this will primarily be for risk monitoring. There</div>\n<div>\n will also be wider benefit in the field of malaria vaccine research in building on data available on</div>\n<div>\n safety and immune responses to R21 which will help with WHO aim to identify a malaria vaccine</div>\n<div>\n with high protection rates. R21c and Matrix-M(MM) have been given to 108 and >1400 healthy adult</div>\n<div>\n human volunteers respectively in the US, Europe, Australia and Burkina Faso. R21c and MM have</div>\n<div>\n both been found to be safe and R21c to provide good vaccine responses. The most common adverse</div>\n<div>\n event seen with both is pain at the injection site which resolves in a few days. The current</div>\n<div>\n formulation is termed R21/MM and has, technically, not been evaluated in human subjects before,</div>\n<div>\n although there is no reason to believe the safety profile and immune responses should be changed by</div>\n<div>\n the slight change in the vaccine, we plan for close and extended follow-up following vaccination.</div>\n<div>\n Participants will be immunised then allowed to go home and followed up daily for 7 days postimmunisation.</div>\n<div>\n Current data show R21c to be safe and immunogenic in 100 malaria-naïve British and</div>\n<div>\n 8 West African adults. We now need to determine if R21/MM is safe and immunogenic in Kenyans</div>\n<div>\n of different ages.</div>\n<div>\n <strong>How will the study benefit society?</strong></div>\n<div>\n This study will build on safety and immunogenicity data on R21 and Matrix M and will provide</div>\n<div>\n safety and immunogenicity for R21/MM which will inform the design of a phase II study of this</div>\n<div>\n candidate malaria vaccine. There is reason to believe this is a promising candidate vaccine given that</div>\n<div>\n a smaller dose is required to illicit a similar vaccine response to RTS,S, manufacture is cheap, the</div>\n<div>\n data thus far on the vaccine and adjuvant MM demonstrates they are safe, the vaccine has less</div>\n<div>\n Hepatitis B protein which may mean a better immune response compared to RTS,S in infants and</div>\n<div>\n pre-clinical vaccine studies followed by challenge with malaria infection have demonstrated that a</div>\n<div>\n high proportion of vaccinated mice fail to develop malaria after deliberate infection.</div>\n<div>\n <strong>When does the study start and finish?</strong></div>\n<div>\n The study will start upon receipt of ethical clearance; data collection, analysis and write up will take place over 3.5 years. </div>\n
      • short_titlestudy to determine if a new malaria vaccine is safe and induces immunity among Kenyan adults, young children and infants.
      • protocol_noECCT/18/12/01
      • version_no1.7
      • date_of_protocol02-10-2018
      • study_drugR21/Matrix-M vaccine
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantMainga Hamaluba
      • declaration_date127-09-2018
      • declaration_principal_investigatorMainga Hamaluba
      • declaration_date227-09-2018
      • placebo_presentNo
      • study_objectives<div>\n Primary objective</div>\n<div>\n To evaluate the safety and tolerability of R21 with adjuvant Matrix-M in healthy adults then</div>\n<div>\n children and finally infants.</div>\n<div>\n Secondary objective(s)</div>\n<div>\n To assess the cellular and humoral immunogenicity of R21 in humans with adjuvant Matrix-</div>\n<div>\n M in healthy adults, children and infants. Immunology bloods will be collected prior to</div>\n<div>\n enrolment and vaccination and during follow-up visits.</div>\n
      • principal_inclusion_criteria<address>\n <address>\n <div>\n <em>•</em><span style=\"white-space:pre\"> </span>Healthy adults aged 18 to 45 years (Group 1), Healthy child aged 1-5 years (Group 2), healthy infant aged 5- <12 months (Group 3)</div>\n <div>\n •<span style=\"white-space:pre\"> </span>Able and willing (in the Investigator’s opinion) to comply with all study requirements</div>\n <div>\n •<span style=\"white-space:pre\"> </span>Non-pregnant, non-lactating adult female or adult male</div>\n <div>\n •<span style=\"white-space:pre\"> </span>Agreement to refrain from blood donation during the study</div>\n <div>\n •<span style=\"white-space:pre\"> </span>Use of effective method of contraception for duration of study for female participants. For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)</div>\n <div>\n •<span style=\"white-space:pre\"> </span>Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or young children and infants with Z-score of weight-for-age within ±3SD </div>\n <div>\n •<span style=\"white-space:pre\"> </span>Provide written informed consent</div>\n <div>\n •<span style=\"white-space:pre\"> </span>Plan to remain resident in the study area for 2 years following last dose of vaccination</div>\n <div>\n  </div>\n </address>\n</address>\n
      • principal_exclusion_criteria<div>\n •<span style=\"white-space:pre\"> </span>Clinically significant congenital abnormalities as judged by the study clinician.
</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Sickle cell disease .</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Any history of anaphylaxis in relation to vaccination. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Clinically significant laboratory abnormality as judged by the study clinician.</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Blood transfusion within one month of enrolment. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. 
</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG). </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. </div>\n<div>\n  </div>\n
      • primary_end_points<div>\n The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. </div>\n<div>\n The following parameters will be assessed for all study groups</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Occurrence of unsolicited adverse events for 28 days following the vaccination</div>\n<div>\n •<span style=\"white-space:pre\"> </span>Change from baseline for safety laboratory measures </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Occurrence of serious adverse events during the whole study duration</div>\n<div>\n  </div>\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_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • 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 font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Medical officer-1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Clinical officer - 2</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Nurses -2</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Fieldworkers - 4</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Assistant Research Officer - 1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Study Coordinator -1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Pharmacisit-1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Data Manager-1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Data Clerk-1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The inpatient facility is already staffed with 3 clincians, 1 paediatrician and 20 nurses.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n All staff are trained in basic life support and resuscitation facilitaties are available</p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n We are only submitting to PPB.</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration3.5 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_areaKEMRI-Wellcome Trust Research Programme (KWTRP) Centre for Geographic Medical Research - Coast (CGMRC), Kilifi, Kenya.
      • single_site_physical_addressKEMRI-Wellcome Trust Research Programme (KWTRP) Centre for Geographic Medical Research - Coast (CGMRC), PO BOX 230-80103, Kilifi, Kenya
      • single_site_contact_personDr. Mainga Hamaluba
      • single_site_telephone+254795320422
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site91
      • total_participants_worldwide91
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • 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_consentYes
      • subjects_specifyThe study will include women aged 18-45 years who are of child bearing age using contraception. The study will also enroll infants and children who are incapable of giving consent.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMainga
      • investigator1_middle_name
      • investigator1_family_nameHamaluba
      • investigator1_qualificationPhD
      • investigator1_professional_addressP.O.Box 230, Kilifi 80108, Kenya
      • investigator1_telephone+254795320422
      • investigator1_emailMHamaluba@kemri-wellcome.org
      • organisations_transferred_No
      • number_participantsN=91 \n[adults (18-45 years)=20, children (1-5 years)=20, and infants (5-<12 months)=51]
      • notification
      • approval_date19-03-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results
      • quantity_importedR21 375, Matrix-M 309
      • quantity_dispensedUsed-R21 327, Matrix-M 229, Wasted R21 7, Matrix-M 2
      • quantity_destroyedR21 41, Matrix-M 78
      • quantity_exported0
      • balance_site0
      • final_date29-05-2025
      • modified2025-09-18 09:45:07
      • created2018-09-27 09:33:53
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id452
        • application_id726
        • given_nameMainga
        • middle_name
        • family_nameHamaluba
        • qualificationPhD
        • professional_addressP.O.Box 230, Kilifi 80108, Kenya
        • telephone+254795320422
        • emailMHamaluba@kemri-wellcome.org
        • created2018-09-27 09:44:28
        • modified2020-02-25 09:14:48
    • SiteDetail(array)
      • 0(array)
        • id572
        • application_id726
        • county_id3
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-09-27 09:44:28
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    • Sponsor(array)
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        • id356
        • application_id726
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personAdrian Hill (Chief Invetigator)
        • addressUniversity Offices, Wellington Square, Oxford, OX1 2JD, UK
        • telephone_number+44 1865 270000
        • fax_number
        • cell_number+44 1865 270000
        • email_addressadrian.hill@ndm.ox.ac.uk
        • created2018-09-27 09:44:28
        • modified2020-02-25 09:14:48
  • 4(array)
    • Application(array)
      • id744
      • user_id611
      • trial_status_id6
      • abstract_of_study<p>\n This is an epidemiology study that intends to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa. GlaxoSmithKline (GSK) Biologicals has developed a pre-erythrocytic Plasmodium (P.) falciparum malaria vaccine, RTS,S/AS01E, for routine immunisation of children living in malaria-endemic countries of sub-Saharan Africa (SSA). The World Health Organization (WHO)’s Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) recommended pilot implementations of RTS,S/AS01E in children of 5–17 months of age, in parts of 3-5 distinct epidemiological settings in sub-Saharan Africa , administering 3 doses of the vaccine to children 5-9 months of age in areas of moderate to-high transmission of malaria with a fourth dose administered 15-18 months following the third dose. In April 2017, the WHO Regional Office for Africa announced that the RTS,S/AS01E vaccine will be first introduced in 3 countries (Ghana, Kenya and Malawi) in 2018 through a WHO-coordinated pilot implementation programme, referred to as the Malaria Vaccine Implementation Programme (MVIP). In order to align with the MVIP, the study sites for the GSK Phase IV studies have been, selected from the 3 countries where the RTS,S/AS01E vaccine will be implemented. Sites from Kenya and Ghana (Malawi sites did not participate in EPI-MAL-002) that were part of study EPI-MAL-002 and also Malawi sites will become study sites in EPI-MAL-003 (EPI-MALARIA-003 VS AME (115056)) which will be exposed clusters. EPI-MAL-003 is a post-implementation study that will further evaluate the safety, effectiveness and impact of the vaccine during initial implementation.</p>\n
      • study_title<p>\n A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa.</p>\n
      • laymans_summary<p>\n GlaxoSmithKline (GSK) Biologicals has developed a malaria vaccine, RTS,S/AS01E, for routine immunisation of children living in malaria-endemic countries of sub-Saharan Africa (SSA). RTS,S/AS01E is the first vaccine to be implemented for the prevention of malaria in the paediatric population. The World Health Organization (WHO)’s Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) recommended pilot implementations of RTS,S/AS01E in children of 5–17 months of age, in parts of 3-5 SSA countries, administering 3 doses of the vaccine to children 5-9 months of age in areas of moderate to- high transmission of malaria with a fourth dose administered 15-18 months following the third dose. In April 2017, the WHO Regional Office for Africa announced that the RTS,S/AS01E vaccine will be first introduced in 3 countries (Ghana, Kenya and Malawi) through a WHO-coordinated pilot implementation programme, referred to as the Malaria Vaccine Implementation Programme (MVIP). In order to align with the MVIP, the study sites for the GSK Phase IV studies have been, selected from the 3 countries where the RTS,S/AS01E vaccine will be implemented. Sites from Ghana and Kenya that were part of study EPI-MAL-002 should become study sites in EPIMAL- 003 which will be exposed clusters. The safety and efficacy of RTS,S/AS01E have been evaluated during pre-authorisation clinical trials conducted mainly in SSA. Study EPI-MALARIA-003 VS AME (115056) will further evaluate the safety, effectiveness and impact of the vaccine during initial implementation. A pre-implementation (i.e. before vaccine implementation) surveillance study, EPI-MALARIA-002 VS AME (115055) will measure the baseline incidence of protocol-defined adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis, malaria morbidity and mortality. The mortality rate, overall and by gender, are also being estimated. EPI-MAL-003 is intended primarily as a post-implementation safety study, together with vaccine effectiveness and impact estimations. In parallel with both EPI-MAL-002 and EPI-MAL-003, a third study (EPI-MALARIA-005 BOD AME [116682] is conducted to measure malaria transmission intensity and other malaria control interventions as confounding factors in the study site areas. The three studies will be conducted in similar if not identical settings. A strong capacity development component is included in the baseline study EPIMAL-002. The study staff (e.g. health care/field worker) will visit the study participant at home or at the local health care facility up to 11 times during the study. Each of these planned study visits should take about 1 hour. If the child takes part in the study and if he/she is found to be unwell at any of the study visits (visits 1 to 9), he/she will be referred to a health care facility and treated under existing Kenya Ministry of Health services/programs. If the medical problem cannot be treated at home or at the nearest health care facility, he/she will be referred to a hospital. If this were to happen, transport will be arranged for this visit to see the doctor. The participant will benefit from regular check-up and advice during the planned visits.</p>\n
      • short_titleEPI 003
      • protocol_noECCT/18/11/02
      • version_no1
      • date_of_protocol11-10-2017
      • study_drugMOSQUIRIX
      • disease_conditionMALARIA
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
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      • comparator_registered
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      • ecct_not_applicable0
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      • email_addressdotigondi3@gmail.com
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      • declaration_applicantDr Bernhards Ogutu
      • declaration_date119-11-2018
      • declaration_principal_investigatorDr Berhnards Ogutu
      • declaration_date219-11-2018
      • placebo_presentNo
      • study_objectives<p>\n Primary objectives • To estimate the incidence of protocol-defined potential adverse events of special interest (AESI), and of other adverse events (AE) leading to hospitalisation or death, in children vaccinated with of RTS,S/AS01E. • To estimate the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E. Secondary objectives Safety In children enrolled in EPI-MAL-003 study (vaccinated with RTS,S/AS01E or not vaccinated with RTS,S/AS01E): • To estimate the incidence of aetiology-confirmed and/or probable meningitis (final classification). • To estimate the incidence of probable meningitis (final classification). • To estimate the incidence of aetiology-confirmed, probable and/or clinically suspected meningitis (final classification). • To estimate the incidence of cerebral malaria (malaria diagnosed by rapid diagnostic test [RDT] and/or microscopy). • To estimate the mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]), overall and by gender. • To describe risk factors for AESI, other AE leading to hospitalisation or death, meningitis, and malaria. • To describe the causes of hospitalisation (including AESI, other AE, meningitis and malaria). • To describe the causes of death, overall and by gender. • To assess the risk of febrile convulsions during the 7-day period and 1-month period following each dose of RTS,S/AS01E. In children enrolled in EPI-MAL-002 or EPI-MAL-003 studies (vaccinated with RTS,S/AS01E or not vaccinated with RTS,S/AS01E): • To monitor trends over time of meningitis cases identified at site level (first line laboratory). • To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed and/or probable meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and meningitis by comparing the incidence of aetiology-confirmed, probable and/or clinically suspected meningitis in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and AESI, and other AE leading to hospitalisation or death by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association between vaccination and cerebral malaria by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. • To assess the potential association, overall and by gender, between vaccination and death by comparing the incidence of these events in children vaccinated with RTS,S/AS01E with the incidence of these events in children not vaccinated with RTS,S/AS01E. Effectiveness and impact • To estimate the vaccine effectiveness (direct effect) and the impact (indirect, total and overall effects) of vaccination with RTS,S/AS01E on the incidence of any malaria (including P. falciparum malaria), severe malaria (including P. falciparum malaria) and cerebral malaria diagnosed by RDT and/or microscopy. • To estimate the vaccine effectiveness (direct effect) and impact (indirect, total and overall effects) of vaccination with RTS,S/AS01E on: o The prevalence of anaemia among hospitalised children. o The incidence of all-cause hospitalizations and hospitalizations attributed to malaria (including P. falciparum). o The mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]) overall and by gender.</p>\n
      • principal_inclusion_criteria<p>\n Study participants’ parent(s)/LAR(s) who, in the opinion of the investigator can comply with the requirements of the protocol • Written Informed Consent provided from either the parent(s) or LAR of the study participant • Study participant living in the HDSS or equivalent surveillance system area For enrolment in the active surveillance – DTP group: children must be aged < 18 months, identified at any administration of DTP/HepB/Hib (or at hospitalisation before 3rd dose of DTP/HepB/Hib in case of hospitalisation and vaccinated with at least one dose of DTP/HepB/Hib). (This group will include children from exposed and unexposed clusters.) OR For enrolment in the active surveillance – Catch-up group: children must be aged < 18 months, received at least one dose of DTP/HepB/Hib vaccine, whose age corresponds to the age after the 3rd dose of DTP/HepB/Hib vaccine and identified at administration of first dose of RTS,S/AS01E vaccine. (This group will include children from exposed clusters only.) OR For enrolment in the enhanced hospitalisation surveillance: children must be aged < 5 years and hospitalised at any time during the study. (This group will include children from exposed and unexposed clusters.)</p>\n
      • principal_exclusion_criteria<p>\n Child in care</p>\n
      • primary_end_points<p>\n • Occurrence of AESI. • Occurrence of other AE leading to hospitalisation or death • Occurrence of aetiology-confirmed meningitis</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Principal Investigator- 1 Dr Bernhards Ogutu Sub Investigators-------3 Dr Allan Otieno Dr Fredrick Olewe Dr John Michael Ongecha Clinical Officers--------2 James Otieno Oloo Solomon Ali Juma Study Coordinator-----1 Nelly Koskei Lab Technologists-----2 Grace Owino Kennedy Ogweno Nurses------------------4 Mrs Agnes Onyango Maureen Mbija Wyclife Misiayi Jael Aran Lab Technician--------1 Festus Okute Pharmacist ------------1 Dr Ruth Wasuna Pharmacy Technician-1 Mathew Onyango Data Clerks-------------2 Erick Otiu Dishon Yoweri Odidi Community Health Worker-1 Florence Adhola Community Health Volunteers—10 Site Facilities------ 24 Facilities ( Level 3 and level 4 facilities) out of which 3 can hospitalize. Ahero Sub County Hospital is the referral point for all the facilities Nyando Sub County. The patients are referred to Jaramogi Oginga Odinga Teaching and Referral Hospital from Ahero County Hospital in case of an emergency.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Ghana FDA only acknowledged on 14Sep2018, approval was not sought. Malawi submission to Regulatory Authorities is not applicable</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration62MONTHS
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites3
      • multi_country_listGhana, Malawi, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site• Ahero Clinical Trials Unit (Dr Bernhards Ogutu) – 3000 patients\n• KEMRI Walter Reed Army Institute of Research (Dr Walter Otieno) – 3000 patients\n• KEMRI CDC Siaya (Dr Simon Kariuki) – 6000 patients\n
      • total_participants_worldwide45,000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyCHILDREN LESS THAN 5 YEARS OLD
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBERNHARDS
      • investigator1_middle_name
      • investigator1_family_nameOGUTU
      • investigator1_qualificationMBChB, MMed (Peds), PhD
      • investigator1_professional_addressP.O.BOX 54, AHERO CLINICAL TRIALS CENTRE
      • investigator1_telephone+254 733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants12,000
      • notification<p>\n This submission has been done on behalf of the 3 Kenyan sites. The other 2 sites will only now submit their site specific documents for approval once the ethics approval has been obtained.</p>\n
      • approval_date25-03-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-03-2020
      • is_child0
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      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
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      • quantity_imported(null)
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      • balance_site(null)
      • final_date(null)
      • modified2025-06-04 20:13:00
      • created2018-11-19 17:44:19
      • total_sites(null)
      • ecitizen_invoice(null)
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        • professional_addressP.O.BOX 54, AHERO CLINICAL TRIALS CENTRE
        • telephone+254 733812613
        • emailogutu6@gmail.com
        • created2018-11-19 17:46:29
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        • contact_personDr Bernhards Ogutu
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          • created2012-06-15 10:27:02
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        • sponsorGlaxoSmithKline Biologicals
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        • contact_personGodfrey Rikhotso
        • addressFlushing Meadows Building, 57 Sloane Street, The Campus, Bryanston, 2021, Gauteng, South Africa
        • telephone_number+27 11 745 6102
        • fax_number+27 11 388 6213
        • cell_number+27 79 223 2180
        • email_addressgodfrey.n.rikhotso@gsk.com
        • created2018-11-19 17:46:29
        • modified2020-03-04 14:45:38
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      • 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