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• trial_statuses(array)
  • 1Recruiting
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  • 3Suspended
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  • 8Writing-up
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• applications(array)
  • 0(array)
    • Application(array)
      • id449
      • user_id309
      • trial_status_id7
      • abstract_of_study<p>\n ABSTRACT Background Laryngeal mask airways (LMAs) are widely used in surgery and are considered to be generally safe. Postoperative sore throat (POST) is a frequent complication following LMA use and can be very distressing to patients. The use of a laryngeal mask airway cuff pressure of between 23 and 24mmhg in alleviating postoperative sore throat has not been investigated. Primary objective • To determine the occurrence of POST between the intervention group in which LMA cuff pressures will be adjusted to 23-24mmhg and the control group in whom only monitoring of LMA cuff pressures will be done Secondary Objectives ï‚— To compare the laryngeal mask airway pressures between the two study groups ï‚— To determine the severity of postoperative sore throat between the two study groups Study Design: A single blind randomized control trial Methods A sample size of eighty patients will be used. This will include ASA 1 and ASA II patients scheduled to receive general anaesthesia with use of an LMA and are having elective surgery Intervention: Laryngeal mask airway cuff pressures will be adjusted in the intervention group by the principal investigator to a pressure of between 23 and 24mmhg.The none intervention group will only have LMA cuff pressures monitored. Data collection Patients will be interviewed at two, six and twelve hours postoperatively. Data of their baseline characteristics, occurrence and severity of POST will be collected. If POST is present, a Numerical Rating Scale (NRS) will be used to assess its severity. Cuff pressures in the two study groups will also be determined Data Analysis Data collected using questionnaires and will be keyed into an MS Excel database and analyzed using Stata Version 10. Occurrence of POST in both study arms will be presented as a proportion and reported together with the 95% confidence interval. The difference in means of cuff pressures in the study arms will be analyzed using the Student t-test. In the event that the cuff pressures do not meet the rules of normality, the Mann-Whitney non-parametric test will be applied. A p value of <0.05 will be considered statistically significant.</p>\n
      • study_title<p>\n EFFECT OF LARYNGEAL MASK AIRWAY MANOMETRY ON POST OPERATIVE SORE THROAT IN SPONTANEOUSLY BREATHING ADULT PATIENTS PRESENTING FOR SURGERY AT AGA KHAN UNIVERSITY HOSPITAL, NAIROBI.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/11/02
      • version_noRef 2015/REC - 12
      • date_of_protocol24-07-2015
      • study_drugEFFECT OF LARYNGEAL MASK AIRWAY MANOMETRY ON POST OPERATIVE SORE THROAT
      • disease_condition POST OPERATIVE SORE THROATIN SPONTANEOUSLY BREATHING ADULT PATIENTS PRESENTING FOR SURGERY AT AGA KHAN UNIVERSITY HOSPITAL, NAIROBI.
      • 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_nameCuff pressure gauge for Larngeal Mask Airway manometry
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdwaruingi@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
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      • 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)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr David Njoroge Waruingi
      • declaration_date110-11-2015
      • declaration_principal_investigatorNational Principal Investigator
      • declaration_date210-11-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion criteria All ASA I and II patients between 18-65 years scheduled to receive general anaesthesia with a laryngeal mask airway for elective surgery</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria • History of ongoing upper respiratory tract infection. • Patients with a failed LMA insertion defined as an unsuccessful laryngeal mask airway placement after two attempts. • Patients with severe gastro oesophageal reflux disease. • Patients with a symptomatic hiatus hernia. • Patients with a BMI> 40kg/m2. • Patients undergoing ENT-Ear Nose and Throat Procedures.</p>\n
      • primary_end_points<p>\n Primary objective • To determine the occurrence of POST between the intervention group in which LMA cuff pressures will be adjusted to 23-24mmhg and the control group in whom only monitoring of LMA cuff pressures will be done Secondary Objectives ï‚— To compare the laryngeal mask airway pressures between the two study groups ï‚— To determine the severity of postoperative sore throat between the two study groups</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyAim of the study\nTo assess the effect of laryngeal mask airway cuff pressure monitoring on incidence of post-operative sore throat in spontaneously breathing adult surgical patients.\n
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n NA</p>\n
      • other_details_explanation<p>\n NA</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Research and Ethics Committee Aga Khan UNiversity Hospital 30270-00100 Nairobi</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration3 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorIntervention: Laryngeal
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAga Khan University Hospital Nairobi
      • single_site_physical_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
      • single_site_contact_personDr David Njoroge Waruingi
      • single_site_telephone254721994598
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site80
      • total_participants_worldwide80
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr David Njoroge Waruingi
      • investigator1_middle_name
      • investigator1_family_nameDavid Njoroge Waruingi
      • investigator1_qualificationMBChB MMed Anaesthesiology
      • investigator1_professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
      • investigator1_telephone254721994598
      • investigator1_emaildwaruingi@gmail.com
      • organisations_transferred_No
      • number_participants80
      • notification
      • approval_date02-12-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-11-2015
      • 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)
      • modified2015-12-02 12:36:02
      • created2015-11-10 11:31:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id299
        • application_id449
        • given_nameProf Vitalis
        • middle_name
        • family_nameMungayi
        • qualificationMBChb MMed Anaesthesiology FICM (SA)
        • professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone254724904010
        • emailvitalis.mungayi@aku.edu
        • created2015-11-10 11:40:39
        • modified2015-11-10 15:43:12
      • 1(array)
        • id300
        • application_id449
        • given_nameDr Edna Kemunto
        • middle_name
        • family_name Gisore
        • qualificationMBChb MMed Anaesthesiology Cardiac Anaesthesia (UK)
        • professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone254722287339
        • emailegisore2000@yahoo.com
        • created2015-11-10 11:53:19
        • modified2015-11-10 15:43:12
      • 2(array)
        • id301
        • application_id449
        • given_nameDr David Njoroge
        • middle_name
        • family_nameWaruingi
        • qualificationMBChb MMed Anaesthesiology
        • professional_addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone254721994598
        • emaildwaruingi@gmail.com
        • created2015-11-10 14:51:22
        • modified2015-11-10 15:43:12
    • SiteDetail(array)
      • 0(array)
        • id360
        • application_id449
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-11-10 11:40:39
        • modified2015-11-10 15:43:12
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id234
        • application_id449
        • sponsorAga Khan University Hospital Nairobi
        • sponsor_type(null)
        • contact_person
        • addressAga Khan University Hospital 30270-00100 3rd Parklands Avenue
        • telephone_number254721994598
        • fax_number
        • cell_number254721994598
        • email_addressdavid.waruingi@aku.edu
        • created2015-11-10 11:40:39
        • modified2015-11-10 15:43:12
  • 1(array)
    • Application(array)
      • id560
      • user_id354
      • trial_status_id6
      • abstract_of_study<p>\n <strong>1.      </strong><strong>ABSTRACT</strong></p>\n<p>\n Schistosomiasis remains a major public health problem in developing countries due to its impact on child health, nutrition, cognitive and physical development. Infection is controlled by treatment using the drug of choice Praziquantel (PZQ). In an endemic setting, schistosome infections overlap with other infections/diseases including geohelminths, and malaria. The World Health Organization together with other Global Initiatives advocate for regular deworming of school children to reduce morbidity.  Pre-school children (aged 1-5 years) who have been until recently excluded from schistosome control programmes can now benefit from treatment. Despite this progress, schistosomiasis-endemic countries including Kenya are still slow in embracing this change. To date, the efficacy of praziquantel treatment for schistosomiasis control in preschool children remains unknown.  Furthermore, despite annual mass treatment of school aged children in the endemic sites, disease prevalence in transmission hotpots remains high with levels of malaria and anemia constantly being indifferent. The incidence of falciparum malaria and immune dynamics due to possible modulation of immune responses by schistosomes and its effects on malaria treatment is the emphasis of this study.  Although there have been studies of malaria-schistosome co-infections, they have been biased towards older primary school children (since these were the target for schistosome control), hence little is known about the dynamics of these co-infection’s in the pre-school children. With emerging studies showing schistosome immunomodulation of the host’s phenotype in young children, there is need to understand the global effects of these responses on health in very young children. This study therefore, focuses on 1-5 year old children endemically exposed to schistosomiasis and malaria, asking the question “what is the immunological impact of schistosome coinfection with malaria on incidence of malaria re-infections, and on immune responses and disease treatment in 1-5 year old children?” It uses an elaborate design allowing (1) assessing the general prevalence and intensity of schistosomiasis in this age group, determining treatment efficacy and identifying potential molecular and immune biomarkers of infection, infection intensity and morbidity (2) determining effect of schistosomiasis infection on <em>Plasmodium falciparum</em> specific cytokine and antibody immune responses, (3) evaluating if active chronic infection is associated to clinical incidence of malaria. This study will therefore evaluate the impact of co-infections on immunological correlates of disease and their consequences for treatment and mass drug administration (MDA) programs. It will also provide information that could be used later as key performance indicators of pediatric PZQ efficacy. This will inform governments and policy makers on health system strengthening strategies to cater for the need of this vulnerable population.</p>\n
      • study_title<p>\n Effect of Schistosoma mansoni infection on incidence of Plasmodium falciparum malaria among 1-5 year old children in western Kenya.</p>\n
      • laymans_summary(null)
      • short_titleEffect of Schistosoma mansoni infection on incidence of Plasmodium falciparum malaria among 1-5 year old children in western Kenya.
      • protocol_noECCT/16/09/03
      • version_no22-03-2016/Version1.1
      • date_of_protocol25-05-2016
      • study_drugPraziquantel (Cesol 600mg)
      • disease_conditionSchistosomiasi
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameBiltricide
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfredrickrawago@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_applicant+254721308588
      • declaration_date127-09-2016
      • declaration_principal_investigatorPrincipal Investigator
      • declaration_date227-09-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria:</strong> (a) Children aged 1-5 years (b) children whose parents/guardians have provided written consent, (c) permanent residents of the area, (d) exposed to S<em>chistosoma mansoni</em> infection -will be enrolled from the two areas and their demographic information obtained. </p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria:</strong> (a) Children whose parents or legal guardians decline to consent to participation in the study, (b) children above 5 years of age, (c) children with <em>Schistosoma haematobium</em>infection and or soil transmitted helminthes will be treated and excluded from the study(d) children with history of sickle-cell disease or any hemoglobinopathies (f) any contraindication to praziquantel according to product information.</p>\n
      • primary_end_points<p>\n The primary outcome will be the number of clinical malaria episodes recorded in children with (Group 1) and without (Group 3) <em>S. mansoni</em> infection during the 24 months of the duration of the studies as measured by:</p>\n<p style=\"margin-left:.75in;\">\n §  Malaria clinical episodes – fever (37.50C or higher) or reported history of fever within the preceding 24 hours accompanied by any level of parasitemia, and fever accompanied by parasitemia ≥ 5,000 parasites/μl of blood. </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n 1. Dr.Pauline NM Mwinzi,PhD-Chief Research Officer(PI)</p>\n<p>\n 2. Dr.Maurice R Odiere,PhD-Senior Research Officer(CO-PI)</p>\n<p>\n 3. Hulda Sang,MSc(PhD student and CO-PI)</p>\n<p>\n 4. Vincent Were,Data Analyst</p>\n<p>\n 5. Fredrick Rawago,BSc,Study coordinator</p>\n<p>\n 6. Musa Jagongo,Dip Community Health Nursing(Study Nurse)</p>\n<p>\n 7. Philip Leakey,Certicate in Med Lab Sciences</p>\n<p>\n 8. Elmartador Otieno Ojijo,Pharm Tech</p>\n<p>\n 9. Dr.Kennedy Ochieng Otieno,M.B,ch,MPH</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 KEMRI,SERU,25TH MAY 2016</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration36 MONTHS--(24 MONTHS FOR INTERVENTION AND 1 YEAR DATA ANALYSIS AND REPORTING)
      • 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 CGHR
      • single_site_physical_addressKISIAN KISUMU
      • single_site_contact_personDR.Pauline NM Mwinzi/Dr.Gerald Mkoji
      • single_site_telephone+254721308588
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwideN/A
      • 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_specifyCHILDREN AGED 1-5 YEARS OLD
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr.Pauline
      • investigator1_middle_nameNM
      • investigator1_family_nameMwinzi
      • investigator1_qualificationPhD
      • investigator1_professional_address1587 40100
      • investigator1_telephone+254721308588
      • investigator1_emailpmwinzi@kemricdc.org
      • organisations_transferred_No
      • number_participants500
      • notification<p>\n Kindly note this is our first clinical trial study application.Your advice will be highly appreciated.</p>\n
      • approval_date28-11-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-11-2016
      • 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)
      • modified2018-10-16 12:12:46
      • created2016-09-27 16:18:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id362
        • application_id560
        • given_nameDr.Pauline
        • middle_nameNM
        • family_nameMwinzi
        • qualificationPhD
        • professional_address1578 40100
        • telephone+254721308588
        • emailPmwinzi@kemricdc.org
        • created2016-09-27 16:25:56
        • modified2016-11-02 10:22:56
    • SiteDetail(array)
      • 0(array)
        • id437
        • application_id560
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-09-27 16:25:56
        • modified2016-11-02 10:22:56
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id290
        • application_id560
        • sponsorKEMRI
        • sponsor_type(null)
        • contact_personDr.Gerald Mkoji
        • addressPO BOX 54840-00200
        • telephone_number+254(0)202713349
        • fax_number+2540572022981
        • cell_number+254721585696
        • email_addressgmkoji@kemri.org
        • created2016-09-27 16:25:56
        • modified2016-11-02 10:22:56
  • 2(array)
    • Application(array)
      • id1024
      • user_id695
      • trial_status_id7
      • abstract_of_study<p>\n In line with WHO recommendations, Kenya conducts Therapeutic Efficacy Studies (TES) for 1^st and 2^nd line antimalarial medicines to monitor the threat of emergence and spread of artemisinin resistance. The objective of this four-arm prospective study is to assess the efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) used for the treatment of uncomplicated <em>P. falciparum </em>malaria among febrile patients aged between 6 and 59 months, with confirmed uncomplicated <em>P.Falciparum</em> monoinfection at one selected site in both Siaya and Bungoma Counties with a high out-patient attendance of malaria patients. At each site, at least 100 patients will be enrolled per drug (200 patients per site, 400 patients total) between July and December 2020. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate AL efficacy, and over a 42-day follow-up period to evaluate DHP efficacy. The study will determine proportion of patients with an adequate clinical and parasitological response (as indicators of efficacy). Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. The study will further determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing. The results will enable Ministry of Health (MOH) make timely update of its malaria treatment and diagnostic policies and ensure global exchange of resistance data.</p>\n<p>\n  </p>\n
      • study_title<p>\n Efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated <em>Plasmodium</em> <em>falciparum</em> malaria in Siaya and Bungoma counties, Kenya.</p>\n
      • laymans_summary<p>\n Jhpiego through the Impact Malaria project funded by the US President’s Malaria Initiative (PMI) and in Collaboration with National Malaria Control Program-Ministry of Health, US Centers of Disease Control and Prevention (CDC), and the County Governments of Siaya and Bungoma plan to carry out a study to test how effective<em> Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) are still in the treatment of uncomplicated Plasmodium falciparum malaria in Siaya and Bungoma counties, Kenya</em>. The purpose of the study is to assess whether these two medicines are currently still effective in the treatment of malaria. The selected project sites will include  one health facility in Siaya and one in Bungoma County. The primary sample will consist of children aged between 6 months and 59 months who are eligible and whom have been confirmed to have uncomplicated malaria and their parents have consented for them to be in the study. Participants who meet the study inclusion criteria will be enrolled, treated on site and monitored.</p>\n<p>\n The results from the study will inform the Ministry of Health on effective current medicines used to treat malaria and if there is any growing resistance in Kenya.</p>\n
      • short_titleTherapeutic Efficacy Study
      • protocol_noECCT/21/06/15
      • version_no1
      • date_of_protocol01-03-2020
      • study_drugArtemether-Lumefantrine and Dihydroartemisinin-Piperaquine
      • disease_conditionUncomplicated malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether-Lumefantrine and Dihydroartemisinin-Piperaquine
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameDihydroartemisinin-Piperaquine
      • comparator_registeredYes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfredouma12@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Fredrick Ouma
      • declaration_date115-06-2021
      • declaration_principal_investigatorDr. Willis Akhwale
      • declaration_date215-06-2021
      • placebo_presentNo
      • study_objectives<ol style=\"list-style-type:upper-alpha;\">\n <li>\n General objective: To assess the therapeutic efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated <em>P. falciparum</em> malaria in Siaya and Bungoma counties, Kenya.</li>\n</ol>\n<p>\n (B) Specific objectives:</p>\n<ol>\n <li>\n To measure the clinical and parasitological efficacy of AL and DHP in patients aged between 6 months and 59 months, suffering from uncomplicated <em>P. falciparum </em>malaria by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy;</li>\n <li>\n To differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis.</li>\n <li>\n To determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing.</li>\n <li>\n To determine the blood concentration of AL</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Age between 6 months to 59 months</li>\n <li>\n Mono-infection with <em>p. Falciparum</em> confirmed by positive blood smear (i.e. No mixed infection)</li>\n <li>\n Parasitaemia of 1,000 – 100,000/µl asexual forms</li>\n <li>\n Presence of axillary temperature ≥ 37.5 °c or history of fever during the past 24 h</li>\n <li>\n Ability to swallow oral medication</li>\n <li>\n Haemoglobin >8.0 g/dl at admission</li>\n <li>\n Informed consent from a parent or guardian</li>\n <li>\n Parent/guardian agrees to bring the patient for the completion of AL and DHP doses and planned follow-up visits at day 7, 14, 21, and 28 plus days 35 and 42 for DHP follow up.</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul>\n <li>\n General danger signs or signs of severe falciparum malaria according to the definitions of WHO (Appendix 2)</li>\n <li>\n Severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition</li>\n <li>\n Mixed or mono-infection with another <em>Plasmodium</em> species detected by microscopy</li>\n <li>\n Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS)</li>\n <li>\n Regular medication, which may interfere with antimalarial pharmacokinetics</li>\n <li>\n History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)</li>\n <li>\n History of receiving any antimalarial treatment in the preceding 72 hours</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response, as defined in Appendix 5.</p>\n<p>\n As parasitological cure is the goal of antimalarial therapy, all study patients who show treatment failure will be given rescue treatment. Follow-up will continue until recovery. The outcome of the rescue treatment in these patients does not need to be recorded systematically for the purpose of the surveillance study.</p>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Kaluo Health Center: They have an inpatient maternity that has 200 deliveries in a month. Kaluo is headed by an experienced Nursing officer in-charge. There are 2 Clinical officer, 1 Lab officer, 1 pharmaceutical officer, 6 Nursing officer, 2 Peer educators, 1 Health and records officer, 1 Data clerk, 2 Adherence counselors and 2 HIV Testing counsellors among other CHVS and support staff.  Three community Units are attached to Kaluo Health centers. Kaluo receives adequate support from Alego Usonga Health Management Team especially the expert Microscopists. Their Infrastructure is adequate with their Lab having listed as a QI lab. The la conducts Tuberculosis, AFBs, Malaria, HB, O/C, Rapid Tests successfully among other biochemistry Tests. The staff undergo frequent trainings for Malaria.</p>\n<p>\n  </p>\n<p>\n Makhonge Health Center: The total case load between Oct 2018 – Sept 2019 was 7021 at the child Welfare clinic. Out of the 2480 suspected Malaria cases from the case load, 957 were positive (prevalence 38.5%). Makhonge is adequately stffed with an inpatient Maternity, Outpatient department, Lab and pharmacy. They have a facility Incharge, 2 Lab staff, 2 Clinical officer, 6 Nursing officers. A pharmacist is set to be posted as the medical supritendent in April 2021. The Lab has the capacity to conduct both Malaria Microscopy and Rapid tests.</p>\n<p>\n  </p>\n<p>\n Impact Malaria funded by PMI will be supporting the facilities with Key Equipment needed for the study as well as consumable items. These included Haemoque machines, Weighing scales, Thermometers, Microscopes, Cuvettes. </p>\n
      • other_details_explanation<p>\n Kenya has high malaria prevalence and endemicity</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationDecember 2021
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPatients on DHAP
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyDihydroartemisinin-Piperaquine
      • 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_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site200
      • total_participants_worldwide400
      • 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_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 aged under 5 years (6 to 59 months)
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMaureen
      • investigator1_middle_nameMoraa
      • investigator1_family_nameMabiria
      • investigator1_qualificationMBChB
      • investigator1_professional_addressImpact Malaria Office - 14 Riverside, Arlington Block
      • investigator1_telephone+254722924636
      • investigator1_emailMaureen.Mabiria@jhpiego.org
      • organisations_transferred_Yes
      • number_participants400
      • notification
      • approval_date11-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-06-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-10-30 16:03:55
      • created2021-06-15 11:52:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
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        • id672
        • application_id1024
        • given_nameDr. Sarah-Blythe
        • middle_name
        • family_nameBallard
        • qualificationMD, MPH, PhD
        • professional_addressCDC
        • telephone+254722509168
        • emailzlo3@cdc.gov
        • created2021-06-15 11:55:00
        • modified2021-06-25 11:52:56
      • 1(array)
        • id673
        • application_id1024
        • given_nameDr. Willis
        • middle_name
        • family_nameAkhwale
        • qualificationMBChB, PhD
        • professional_addressALMA - Ministry of Health, Afya House
        • telephone+254721788913
        • emailwakhwale@alma2030.org
        • created2021-06-15 12:11:37
        • modified2021-06-25 11:52:56
      • 2(array)
        • id678
        • application_id1024
        • given_nameDr. Grace
        • middle_name
        • family_nameIkahu
        • qualificationMBChB, MPH
        • professional_addressAfya House, Nairobi
        • telephone+254721238791
        • emailmuchangigrace@gmail.com
        • created2021-06-17 20:51:59
        • modified2021-06-25 11:52:56
      • 3(array)
        • id679
        • application_id1024
        • given_nameDr. George
        • middle_name
        • family_nameGithuka
        • qualificationMBChB, MSc Field Epidemiology
        • professional_addressKNH Grounds, Nairobi
        • telephone+254722303481
        • emailgngithuka@yahoo.com
        • created2021-06-17 20:51:59
        • modified2021-06-25 11:52:56
      • 4(array)
        • id680
        • application_id1024
        • given_nameDr. Dickson
        • middle_nameMtungu
        • family_nameMwakangalu
        • qualificationMBChB, MPH
        • professional_addressImpact Malaria Office - 14 Riverside, Arlington Block
        • telephone+254722726184
        • emaildmtungu@gmail.com
        • created2021-06-17 20:51:59
        • modified2021-06-25 11:52:56
      • 5(array)
        • id681
        • application_id1024
        • given_nameDr. Elvis
        • middle_nameOmondi
        • family_nameOyugi
        • qualificationMBChB, MSc Field Epidemiology
        • professional_addressDNMP, KNH Grounds, Nairobi
        • telephone+254720483652
        • emaileloyugi@gmail.com
        • created2021-06-17 21:09:23
        • modified2021-06-25 11:52:56
      • 6(array)
        • id682
        • application_id1024
        • given_nameHellen
        • middle_name
        • family_nameGatakaa
        • qualificationBSc, MSc
        • professional_addressImpact Malaria Office - 14 Riverside, Arlington Block
        • telephone+254722865158
        • emailHellen.Gatakaa@jhpiego.org
        • created2021-06-17 21:09:23
        • modified2021-06-25 11:52:56
      • 7(array)
        • id683
        • application_id1024
        • given_nameRegina
        • middle_nameJepkosgei
        • family_nameKandie
        • qualificationBSc, MSc
        • professional_addressDNMP, KNH Grounds, Nairobi
        • telephone+254722841252
        • emailregkandie@gmail.com
        • created2021-06-17 21:09:23
        • modified2021-06-25 11:52:56
      • 8(array)
        • id684
        • application_id1024
        • given_nameDr. Fredrick
        • middle_nameOuma
        • family_nameOdhiambo
        • qualificationBPharm
        • professional_addressDNMP, KNH Grounds, Nairobi
        • telephone+254724976545
        • emailfredouma12@gmail.com
        • created2021-06-18 09:42:53
        • modified2021-06-25 11:52:56
    • SiteDetail(array)
      • 0(array)
        • id939
        • application_id1024
        • county_id39
        • site_nameMahonge Health Center
        • physical_addressMahonge Market, Kimilili Sub-county, Bungoma County
        • contact_details+254724514760
        • contact_personFacility In-charge
        • site_capacity(null)
        • misc(null)
        • created2021-06-15 11:55:00
        • modified2021-06-25 11:52:56
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 1(array)
        • id946
        • application_id1024
        • county_id41
        • site_nameKaluo Health Center
        • physical_addressAlego-Usonga Sub-county, Siaya County
        • contact_details+254721579199
        • contact_personFacility in-charge
        • site_capacity(null)
        • misc(null)
        • created2021-06-17 20:19:33
        • modified2021-06-25 11:52:56
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id514
        • application_id1024
        • sponsorPresident Malaria Initiative (PMI)
        • sponsor_typeOthers
        • contact_personDr Sarah-Blythe Ballard
        • addressUS Embassy, United Nations Avenue, Nairobi - Kenya
        • telephone_number+254722509168
        • fax_number
        • cell_number+254722509168
        • email_addresszlo3@cdc.gov
        • created2021-06-15 11:55:00
        • modified2021-06-25 11:52:56
  • 3(array)
    • Application(array)
      • id248
      • user_id81
      • trial_status_id5
      • abstract_of_study<p>\n Malaria transmission is falling in some parts of Africa as bednets and anti-malarials become more widely available. However, transmission still persists and it appears that additional control measures are required. The leading malaria vaccine candidate in development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the field. This partial protection might be enhanced by combination with other components. The other vaccination approach that has produced repeatable efficacy in humans is the use of viral vectors to induce T cell responses. Previous attempts with this vaccine approach have been effective in challenge studies in Oxford, but ineffective in the field, probably because of reduced immunogenicity.</p>\n<p>\n Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with thrombospondin- related adhesion protein (ME-TRAP).</p>\n<p>\n The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and partial protection in 5 out of 14 volunteers in challenge studies. It is important to determine efficacy before having larger trials in children.</p>\n<p>\n We propose a Phase 2b study of 120 healthy adult men in Kenya. We will assess the efficacy and further evaluate the immunogenicity and safety profile of the vaccine regimen. We also intend to assess the correlates of efficacy and natural immunity.</p>\n
      • study_title<p>\n Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against <em>Plasmodium falciparum </em>infection.</p>\n
      • laymans_summary<p>\n Malaria is a common and serious disease in young children that results in many childhood deaths. Although malaria is becoming less frequent in some parts of Africa as bed nets and anti-malarial drugs become more available, vaccines are still needed to prevent malaria as it is still a major problem.<br />\n <br />\n Everywhere in the world, when new drugs or vaccines are being developed for children, research is first done in a few healthy adults, then in bigger numbers of healthy adults before children can finally be included. This malaria vaccine study is the same. Some studies involving small groups of adults in the UK, Gambia and Kenya and in older children in the Gambia have already been done and showed that the vaccine helps people to develop protection against malaria and had no serious side effects. We are now trying to conduct research on the vaccine with larger numbers of healthy adults.<br />\n <br />\n We do not know whether the new malaria vaccine will protect people against infection, so particpants should take the usual measures to prevent malaria infection from mosquito bites during, and following the trial. These measures include the use of bed nets and seeking treatment for any illness including malaria.<br />\n <br />\n In research to find out how well a vaccine is working, researchers usually have to compare two groups of similar people where only one group has been given the vaccine being developed. Both groups of people are followed up over time to see which group develops best protection against malaria. This allows us to understand how well the new vaccine is working.<br />\n <br />\n In this study, we shall divide the participants into two groups. The new malaria vaccine will be given to one group and another vaccine that we know does not protect against malaria will be given to the other group. The vaccine we will use in the comparison group is rabies, which is a very useful vaccine that is already in use worldwide to protect people against the illness called rabies. Rabies can be caught from being bitten by an infected animal. People will be divided into the groups using a system based on chance without any preference, such that everyone has the same chance of being in either group. We hope to include 120 healthy adult men in this study, with 60 in each group.<br />\n <br />\n Participants will be given either the new malaria or the rabies vaccine, depending on which group they are allocated to. Both vaccines will be given in two doses; the first in week 1(day 0) and the second in week 9(day 56). They will be asked to remain at the clinic for half an hour after each vaccination to check for any side effects. A field worker will visit them at home on the first day after each vaccination to check on their progress. If necessary, they will continue to visit participants at home daily until any symptom(s) have resolved. At this visit, the field worker will also ask questions about their use of bed nets in the home and will also ask for permission to check their bed net.</p>\n<p>\n Participants will be asked to take anti-malarial drugs starting from week 10(day 63), in order to clear any malaria parasites that may be in their blood. It is possible to have malaria without having any symptoms. The anti-malarial drugs will be administered in the clinic over 3 days. They will also be required to come to the clinic should they be unwell and in need of anti-malarials, at any other time during the study period.</p>\n<p>\n Blood sampling will be done several times as part of the research in order to check on how well the vaccine is working and how their body is reacting to the vaccine. Some blood samples will be taken from the arm and some from a finger prick. During these scheduled clinic visits, the clinician will also check on their health in general. There will be a total of 24 scheduled clinic visits.<br />\n <br />\n  </p>\n
      • short_titleVAC 46 Trial
      • protocol_noECCT/11/12/02
      • version_no1.3
      • date_of_protocol04-05-2012
      • study_drugChimpanzee adenovirus 63 ME-TRAP & Modified vaccinia Virus Ankara ME-TRAP
      • 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
      • comparatorYes
      • comparator_nameVerorab vaccine; for rabies
      • comparator_registeredYes
      • comparator_countriesKenya, UK, USA and other 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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantCaroline Ogwang
      • declaration_date121-01-2014
      • declaration_principal_investigatorPhilip Bejon (investigator)
      • declaration_date221-01-2014
      • placebo_presentNo
      • study_objectives<p>\n Primary objective<br />\n To assess the efficacy of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME- TRAP in healthy adults in Kenya.<br />\n <br />\n Secondary objectives<br />\n To assess the immunogenicity and correlates of efficacy of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME-TRAP in healthy adults in Kenya.<br />\n <br />\n To assess the safety and reactogenicity of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME-TRAP in healthy adults in Kenya.<br />\n <br />\n To assess the impact of natural immunity (cellular and humoural) on time to re-infection in healthy adults in Kenya<br />\n <br />\n  </p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Consenting adult males aged 18 – 50 years in good health.</li>\n <li>\n Will remain resident in the study area for the study duration.</li>\n <li>\n Able and willing (in the Investigator’s opinion) to comply with all study requirements</li>\n <li>\n Informed Consent</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data</li>\n <li>\n Hypersensitivity to Verorab, the trial vaccines or the antimalarial used.</li>\n <li>\n History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin</li>\n <li>\n History of splenectomy.</li>\n <li>\n Haemoglobin less than 10.0 g/dl</li>\n <li>\n Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels).</li>\n <li>\n Blood transfusion within the month preceding enrolment.</li>\n <li>\n History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findings of study (e.g. other MVA or adenovirus vectored vaccines)</li>\n <li>\n Administration of any other vaccine or immunoglobulin within 2 weeks before vaccination.</li>\n <li>\n HIV or Hepatitis B surface antigen seropositivity.</li>\n <li>\n Current participation in another clinical trial or recent participation within 12 weeks of this study.</li>\n <li>\n Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.</li>\n <li>\n Likelihood of travel away from the study area</li>\n</ul>\n
      • primary_end_points<p>\n We will compare active and control vaccination for time to first episode of <em>P.falciparum</em> infection, defined as 2 or more consecutive blood samples confirmed positive by PCR, for <em>P.falciparum</em></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n Key investigators</td>\n <td style=\"width:213px;\">\n Qualification</td>\n <td style=\"width:213px;\">\n Experience</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n  </td>\n <td style=\"width:213px;\">\n  </td>\n <td style=\"width:213px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Caroline Ogwang</td>\n <td style=\"width:213px;\">\n MBChB</td>\n <td style=\"width:213px;\">\n Has been the lead clincian in a number of vaccine trials and has also been involved in drug trials.</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Kevin Marsh</td>\n <td style=\"width:213px;\">\n PhD in immunology</td>\n <td style=\"width:213px;\">\n Has extensive research experience in malaria immunology and has been a lead investigator in a number of clinical trials.</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Britta Urban   </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n PhD in immunology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience immunological work and analysis both interenally and externally.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Domtila Kimani</p>\n </td>\n <td style=\"width:213px;\">\n <pre>\nMSc in immunology</pre>\n <p>\n  </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has experience in immunological work and analysis in several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Margaret Mackinnon                      </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n PhD in immunology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has experience in immunological work moreso in genetics.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Jimmy Shangala         </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BPharm</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in IMP management for drug and vaccine trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Patricia Njuguna                                </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Mmed in Paediatrics</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in overseeing clinical trials and trial design.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Philip Bejon</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Phd in vaccinology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in overseeing clinical trials and trial design both internally and externally. Has great experience in immunological work.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Evelyne Gitau</td>\n <td style=\"width:213px;\">\n PhD in immunology</td>\n <td style=\"width:213px;\">\n Has experience in malaria immunology</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Peninah Soipei</td>\n <td style=\"width:213px;\">\n Registered Community Nurse/ Masters in Clinical trial management</td>\n <td style=\"width:213px;\">\n Has vast experience in co-ordinating clinical trials.</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Brian Mutinda</td>\n <td style=\"width:213px;\">\n Bsc in computer science</td>\n <td style=\"width:213px;\">\n Has experience in clinical trial data management</td>\n </tr>\n </tbody>\n</table>\n<p>\n Others include field workers, a data clerk, , lab technicians and a pharmacy technician.</p>\n<p>\n The trial site has drugs for managing adverse events. Any participant requiring specilaist care will be reffered to Kilifi District Hospital. Resucitation equipment is present on site and the study clinicians have been trained on emergency life support.</p>\n
      • other_details_explanation<p>\n This phase IIb trial is being done in Kenya because malaria is endemic in Kenya unlike the United Kingdom.</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</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_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorVerorab rabies vaccine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaJunju Dispensary
      • single_site_physical_addressP.O.BOX 96, VIPINGO.
      • single_site_contact_personCaroline Ogwang
      • single_site_telephone+254 417 522535
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwideN/A
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNA
      • investigator1_middle_name
      • investigator1_family_nameNA
      • investigator1_qualificationNA
      • investigator1_professional_addressNA
      • investigator1_telephoneNA
      • investigator1_emailcogwang@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants120
      • notification
      • approval_date19-12-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n <p style=\"margin-left:144.0pt;\">\n  </p>\n <table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Study title:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against <em>Plasmodium falciparum </em>infection</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Study product(s) or intervention(s):</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n ChAd63 ME-TRAP, MVA ME- TRAP</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Indication/condition/therapeutic area:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n Malaria</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Is the study randomised and controlled?</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n Randomised</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Clinical trial phase:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n Phase IIb</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Study start date:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n 13^th February 2012</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Study end date:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n 30^th July 2014</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Chief and/or Principal Investigator:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n Dr Caroline Ogwang</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Sponsor(s):</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n University of Oxford</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Funder(s):</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n European and Developing Countries Clinical Trial Partnership</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:319px;\">\n <p>\n Date of report:</p>\n </td>\n <td style=\"width:319px;\">\n <p>\n 8^th November, 2018</p>\n </td>\n </tr>\n </tbody>\n </table>\n <p>\n  </p>\n <p>\n This study was conducted in compliance with ICH Good Clinical Practice (GCP) and the WMA Declaration of Helsinki.</p>\n <p>\n  </p>\n <p>\n Ethical approval was sought and obtained from: Scientific and Ethics Review Unit, KEMRI and Oxford Tropical Research Ethics Committee(OxTREC).</p>\n <p>\n Regulatory approval was sought and obtained from: The Expert Committee of Clinical Trials, Pharmacy and Poisons Board.</p>\n <p>\n  </p>\n  \n <p>\n  </p>\n <h1>\n 1 Title</h1>\n <p>\n Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against <em>Plasmodium falciparum </em>infection.</p>\n <p>\n  </p>\n <p>\n  </p>\n <h1>\n 2 Investigators</h1>\n <p>\n Caroline Ogwang(PI)</p>\n <p>\n Patricia Njuguna(PI)</p>\n <p>\n Philip Bejon</p>\n <p>\n Peninah Soipei</p>\n <p>\n Margaret Mackinnon</p>\n <p>\n Britta Urban</p>\n <p>\n Domtila Kimani</p>\n <p>\n Evelyn Gitau</p>\n <p>\n Ken Awuondo</p>\n <p>\n Jimmy Shangala</p>\n <p>\n Brian Mutinda</p>\n <p>\n Kevin Marsh</p>\n <p>\n (Kenya Medical Research Institute, Centre for geographic Medicine Research – Coast)</p>\n <p>\n  </p>\n <p>\n Adrian Hill</p>\n <p>\n Susanne Sheehy</p>\n <p>\n Nicholas Anagnostou</p>\n <p>\n Alison Lawrie</p>\n <p>\n Rachel Roberts</p>\n <p>\n (Jenner Institute, Nuffield Dept. of Clinical Medicine, University of Oxford)</p>\n <p>\n  </p>\n <p>\n  </p>\n <h1>\n 3 Study description</h1>\n <p>\n  </p>\n <p>\n The leading malaria vaccine candidate in development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the field(1, 2). This partial protection might be enhanced by combination with other components. The other vaccination approach that has produced repeatable efficacy in humans is the use of viral vectors to induce T cell responses. Previous attempts with this vaccine approach have been effective in challenge studies in Oxford, but ineffective in the field, probably because of reduced immunogenicity.</p>\n <p>\n Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with thrombospondin- related adhesion protein (ME-TRAP)(3-10).</p>\n <p>\n  </p>\n <p>\n The increase in immunogenicity has led to sterile protection in 3 out of 14 volunteers and partial protection in 5 out of 14 volunteers in challenge studies(11). It is important to determine efficacy before having larger trials in children. We conducted a Phase 2b study of 120 healthy adult men in Kenya. We assessed the efficacy and further evaluated the immunogenicity and safety profile of the vaccine regimen.</p>\n <p>\n  </p>\n <h1>\n 4 Trial design</h1>\n <p>\n This was a single blinded controlled phase IIb efficacy study. </p>\n <p>\n  </p>\n <h1>\n 5 Methods</h1>\n <p>\n  </p>\n <h2>\n 5.1 Participants</h2>\n <p>\n The investigation took place at the KEMRI Centre for Geographic Medicine Research- Coast, Kilifi. 120 healthy adult male participants aged 18 – 50 years residing within Kilifi district, Junju location were recruited.</p>\n <h2>\n 5.2 Intervention(s)</h2>\n <p>\n Subjects were randomized to receive either ChAd63 ME-TRAP and MVA ME-TRAP or control vaccination with Verorab(rabies vaccine). To preserve blinding, Verorab was administered in a 0, 2-month schedule; there is evidence that two vaccines may be immunogenic and may provide some efficacy against rabies.  In addition, all participants were offered a standard schedule of Verorab after the trial comes to an end.</p>\n <p>\n  </p>\n <h2>\n 5.3 Objective(s)</h2>\n <p style=\"margin-left:36.0pt;\">\n <strong><u>Primary objective</u></strong></p>\n <p style=\"margin-left:36.0pt;\">\n  </p>\n <p>\n To assess the efficacy of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME- TRAP in healthy adults in Kenya.</p>\n <p style=\"margin-left:36.0pt;\">\n  </p>\n <p style=\"margin-left:36.0pt;\">\n <strong><u>Secondary objectives</u></strong></p>\n <p style=\"margin-left:36.0pt;\">\n  </p>\n <p>\n To assess the immunogenicity and correlates of efficacy of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME-TRAP in healthy adults in Kenya.</p>\n <p>\n  </p>\n <p>\n To assess the safety and reactogenicity of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME-TRAP in healthy adults in Kenya.</p>\n <p>\n  </p>\n <p>\n To assess the impact of natural immunity (cellular and humoural) on time to re-infection in healthy adults in Kenya</p>\n <p>\n  </p>\n <h3>\n Null hypothesis</h3>\n <p>\n There is no delay in time to infection between vaccinees and control vaccinees with <em>P. falciparum </em>as determined by PCR based monitoring following curative anti-malarials in malaria-exposed adults in Kenya.</p>\n <p>\n  </p>\n <h2>\n 5.4 Outcome(s)</h2>\n <p>\n <strong>Primary Endpoint – Vaccine Efficacy</strong></p>\n <p>\n We compared active and control vaccination for time to first episode of <em>P.falciparum</em> infection, defined as 2 or more consecutive blood samples confirmed positive by PCR, for <em>P.falciparum</em>.</p>\n <p>\n  </p>\n <p>\n <strong>Secondary & Tertiary Endpoints – Vaccine immunogenicity & Reactogenicity</strong></p>\n <p>\n Measures of immunogenicity included:</p>\n <p>\n Ex vivo ELISPOT responses to overlapping pools of ME – TRAP peptides.</p>\n <p>\n Cultured ELISPOT responses to overlapping pools of ME – TRAP peptides.</p>\n <p>\n ICS by flow cytometry for cell mediated immune responses</p>\n <p>\n ELISA for antibodies to malaria antigens</p>\n <p>\n All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.</p>\n <h2>\n 5.5 Randomisation</h2>\n <p>\n  </p>\n <p>\n Simple randomisation into the study groups was done by an independent statistician and the study clinicians with an allocation ratio of 1:1 to study groups taking into account their area of residence. A randomization code list was generated by an independent statistician and its use guided by a clear standard of operating procedure (SOP).  Allocation concealment was employed by use of opaque sealed envelopes.</p>\n <p>\n  </p>\n <p>\n  </p>\n <h2>\n 5.6 Blinding (masking)</h2>\n <p>\n  </p>\n <p>\n The volunteers, fieldworkers and laboratory scientists were blinded to vaccine allocation until the end of the study, but the clinical investigators were not blinded. </p>\n <p>\n  </p>\n <h1>\n 6 Results</h1>\n <p>\n  </p>\n <p>\n Vaccine related adverse events were mild to moderate in intensity with no serious adverse events.  Peak immunogenicity was high, at 1,698 spots per million peripheral blood mononuclear cells (PBMC), 95% confidence interval (CI) 1,445 to 2,042, among ME-TRAP vaccinees and 74 spots per million PBMC, 95%CI 47 to 120, among control vaccines.  11 of 60 ME-TRAP vaccinees became PCR positive during 56 days of monitoring compared with 28 of 59 control vaccinees.  By Cox regression, vaccine efficacy was 67% (95%CI 33% to 83%), p=0.002.  4 ME-TRAP vaccines and 19 rabies vaccinees met the secondary endpoint definition of PCR positivity at >10 parasites per ml, for which vaccine efficacy was 82% (95%CI 46% to 94%), p=0.002, by Cox regression.</p>\n <p>\n  </p>\n <h2>\n 6.1 Recruitment</h2>\n <p>\n Summary of population recruited, sites of recruitment, recruitment duration. Screening of Participants started on 13/02/2012 and ended on 05/03/2012; a total of 187 participants were screened. Enrolment was conducted between 12/03/2018 and 21/03/2018. Participant study ID 088 who had been enrolled and received the 1^st vaccination dose was withdrawn from the study soon after enrolment after it was discovered that he had a low Hb at screening; this had been missed during enrolment. This resulted in a total of 121 participants being enrolled into the study. Out of the 66 participants who were not enrolled; 34 where eligible and 32 screen failures.</p>\n <p>\n  </p>\n <h3>\n First participant first visit date:12/03/2012</h3>\n <h3>\n First participant last visit date:20/08/2012</h3>\n <h3>\n Last participant first visit date:21/03/2012</h3>\n <h3>\n Last participant last visit date: 29/08/2012</h3>\n <p>\n  </p>\n <h2>\n 6.2 Numbers randomised</h2>\n <p>\n These have been outlined in the CONSORT Flow diagram (see figure 1 below.)</p>\n <h2>\n 6.3 Numbers analysed</h2>\n <p>\n These have been outlined in the CONSORT Flow diagram (see figure 1 below.)</p>\n <p>\n            </p>\n <h2>\n 6.4 Outcome</h2>\n <p>\n Vaccine efficacy has been described in table 1 below.</p>\n <p>\n  </p>\n <p>\n <strong>Table 1: Vaccine Efficacy by Cox Regression </strong></p>\n <table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:615px;\" width=\"615\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:133px;height:20px;\">\n <p>\n  </p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:75px;height:20px;\">\n <p>\n <strong>ME-TRAP</strong></p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:57px;height:20px;\">\n <p>\n <strong>Rabies</strong></p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:179px;height:20px;\">\n <p>\n <strong>Unadjusted Efficacy</strong></p>\n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:170px;height:20px;\">\n <p>\n <strong>Adjusted Efficacy</strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:133px;height:35px;\">\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:37px;height:35px;\">\n <p>\n N</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:38px;height:35px;\">\n <p>\n n</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:35px;\">\n <p>\n N</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:35px;\">\n <p>\n n</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:35px;\">\n <p>\n Efficacy (95% CI)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:57px;height:35px;\">\n <p>\n p</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:35px;\">\n <p>\n Efficacy (95% CI)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:47px;height:35px;\">\n <p>\n P</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:133px;height:52px;\">\n <p>\n <strong>Any PCR positivity</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:37px;height:52px;\">\n <p>\n 60</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:38px;height:52px;\">\n <p>\n 11</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:52px;\">\n <p>\n 59</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:52px;\">\n <p>\n 28</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:52px;\">\n <p>\n 67% (33%-83%)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:57px;height:52px;\">\n <p>\n 0.002</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:52px;\">\n <p>\n 66% (31%-83%)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:47px;height:52px;\">\n <p>\n 0.003</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:133px;height:51px;\">\n <p>\n <strong>>10 parasites/ml</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:37px;height:51px;\">\n <p>\n 60</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:38px;height:51px;\">\n <p>\n 4</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:51px;\">\n <p>\n 59</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:51px;\">\n <p>\n 19</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:51px;\">\n <p>\n 82% (46%-94%)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:57px;height:51px;\">\n <p>\n 0.002</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:51px;\">\n <p>\n 81% (42%-94%)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:47px;height:51px;\">\n <p>\n 0.003</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:133px;height:103px;\">\n <p>\n <strong>Different genotype after anti-malarials</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:37px;height:103px;\">\n <p>\n 60</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:38px;height:103px;\">\n <p>\n 5</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:103px;\">\n <p>\n 59</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:28px;height:103px;\">\n <p>\n 14</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:103px;\">\n <p>\n 67% (7%-88%)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:57px;height:103px;\">\n <p>\n 0.035</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:123px;height:103px;\">\n <p>\n 65% (2%-87%)</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:47px;height:103px;\">\n <p>\n 0.046</p>\n </td>\n </tr>\n </tbody>\n </table>\n <p>\n N=Numbers of participants, n=number of endpoints identified.  Efficacy figures are estimated from Cox regression where efficacy=(1-HR)x100%</p>\n <p>\n  </p>\n <p>\n  </p>\n <h2>\n 6.5 Safety</h2>\n <p>\n Participants were observed for 30 minutes post each immunization, and visited at home by a field worker the next day.  The local solicited reactions were; pain, discoloration, swelling, warmth, pruritus, scaling or blistering at the injection site. Systemic solicited reactions were; fever, malaise, arthralgia, headache, myalgia and nausea or vomiting.  Clinical criteria were used to grade the intensity of adverse events (AEs) as mild, moderate or severe as described in detail in supplementary table S1.  Unsolicited adverse events within 30 days of each immunization were recorded and causality determined according to clinical criteria in supplementary table 2.  Serious adverse events (SAEs) were assessed throughout the study period.  The full blood count, plasma creatinine and alanine aminotransferase was assessed at 14 and 56 days after ChAd63 ME-TRAP vaccination and at 7 and 105 days after MVA ME-TRAP. Vaccine related adverse events were mild to moderate in intensity with no serious adverse events. </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n <strong>Table 2: Post vaccination Adverse Events</strong></p>\n <table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"615\">\n <tbody>\n <tr>\n <td rowspan=\"2\" style=\"width:105px;height:37px;\">\n  </td>\n <td colspan=\"2\" rowspan=\"2\" style=\"width:180px;height:37px;\">\n <p>\n <strong>ChAd63 ME-TRAP</strong></p>\n </td>\n <td colspan=\"2\" rowspan=\"2\" style=\"width:161px;height:37px;\">\n <p>\n <strong>MVA ME-TRAP</strong></p>\n </td>\n <td colspan=\"2\" rowspan=\"2\" style=\"width:170px;height:37px;\">\n <p>\n <strong>Rabies vaccine</strong></p>\n </td>\n <td height=\"55\" style=\"height:37px;\">\n  </td>\n </tr>\n <tr>\n <td height=\"55\" style=\"height:37px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n  </td>\n <td colspan=\"2\" style=\"width:180px;height:22px;\">\n <p>\n n=61</p>\n </td>\n <td colspan=\"2\" style=\"width:161px;height:22px;\">\n <p>\n n=59</p>\n </td>\n <td colspan=\"2\" style=\"width:170px;height:22px;\">\n <p>\n n=120</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"7\" style=\"width:615px;height:23px;\">\n <p>\n <strong>LOCAL AEs</strong></p>\n </td>\n <td height=\"35\" style=\"height:23px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:43px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:104px;height:43px;\">\n <p>\n Moderate</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n Moderate</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n Moderate</p>\n </td>\n <td height=\"65\" style=\"height:43px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:43px;\">\n <p>\n Pain</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 16 (26%)</p>\n </td>\n <td style=\"width:104px;height:43px;\">\n <p>\n 1(2%)</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 41(69%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 14(24%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 11(9%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td height=\"65\" style=\"height:43px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Swelling</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 8 (14%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:43px;\">\n <p>\n Discoloration</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:104px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 5 (8%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td height=\"65\" style=\"height:43px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Warmth</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 9 (15%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 2(2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Itch</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 2(2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Blistering</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 1(1%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Scaling</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"7\" style=\"width:615px;height:18px;\">\n <p>\n <strong>SYSTEMIC AEs</strong></p>\n </td>\n <td height=\"27\" style=\"height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:43px;\">\n <p>\n Headache</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 3 (5%)</p>\n </td>\n <td style=\"width:104px;height:43px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 9 (15%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 3(3%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td height=\"65\" style=\"height:43px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:43px;\">\n <p>\n Malaise</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 9 (15%)</p>\n </td>\n <td style=\"width:104px;height:43px;\">\n <p>\n 2 (3%)</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 15 (25%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 9(8%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 2(2%)</p>\n </td>\n <td height=\"65\" style=\"height:43px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:43px;\">\n <p>\n Arthralgia</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:104px;height:43px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:76px;height:43px;\">\n <p>\n 2 (3%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 1(1%)</p>\n </td>\n <td style=\"width:85px;height:43px;\">\n <p>\n 0</p>\n </td>\n <td height=\"65\" style=\"height:43px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Feverish</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 2 (3%)</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 2 (3%)</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 3 (5%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Nausea</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 2(2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Myalgia</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 5 (8%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 2 (3%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 5(4%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:105px;height:22px;\">\n <p>\n Fever</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:104px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:76px;height:22px;\">\n <p>\n 1 (2%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 4 (7%)</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td style=\"width:85px;height:22px;\">\n <p>\n 0</p>\n </td>\n <td height=\"33\" style=\"height:22px;\">\n  </td>\n </tr>\n </tbody>\n </table>\n <p>\n  </p>\n <p>\n Adverse events are presented per dose of vaccine.  Therefore, the aggregate doses of rabies vaccine are n=120 (two doses per participant).  Percentages are given in parenthesis.</p>\n <p>\n  </p>\n <p>\n  </p>\n <h1>\n 7 Conclusions</h1>\n <p>\n This two-dose vectored vaccination approach targeting the liver-stage of malaria shows promise as a candidate malaria vaccine. We conclude that PCR monitoring for malaria infection is a sensitive and specific means of identifying endpoints with which to study vaccine efficacy that can be applied to relatively modest sample sizes.  The ChAd63-MVA vaccination strategy should be examined for protective efficacy against clinical malaria in paediatric populations, both alone and in combination with other promising and potentially synergistic vaccination approaches(12).</p>\n <p>\n  </p>\n <h2>\n 7.1 Trial registration</h2>\n <p>\n Trial ID: PACTR201202000356208</p>\n <h2>\n 7.2 Funding</h2>\n <p>\n European and Developing Countries Clinical Trial Partnership</p>\n <p>\n  </p>\n <h1>\n 8 Appendices</h1>\n <h2>\n 8.1 CONSORT Flow Diagram</h2>\n <p>\n  </p>\n <p>\n Figure 1: CONSORT diagram of study progress. </p>\n <p>\n  </p>\n <p>\n <img height=\"492\" src=\"file:///C:/Users/cogwang/AppData/Local/Temp/msohtmlclip1/01/clip_image002.png\" width=\"580\" /></p>\n <p>\n <img border=\"0\" height=\"492\" src=\"file:///C:/Users/cogwang/AppData/Local/Temp/msohtmlclip1/01/clip_image002.png\" width=\"580\" /></p>\n <p>\n  </p>\n <h2>\n 8.2Citations to published articles</h2>\n <p>\n  </p>\n <p>\n 1.         Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, et al. Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med. 2008;359(24):2521-32.</p>\n <p>\n 2.         Olotu A, Lusingu J, Leach A, Lievens M, Vekemans J, Msham S, et al. Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5-17 months in Kenya and Tanzania: a randomised controlled trial. Lancet Infect Dis. 2011;11(2):102-9.</p>\n <p>\n 3.         Bejon P, Kai OK, Mwacharo J, Keating S, Lang T, Gilbert SC, et al. Alternating vector immunizations encoding pre-erythrocytic malaria antigens enhance memory responses in a malaria endemic area. Eur J Immunol. 2006;36(8):2264-72.</p>\n <p>\n 4.         Bejon P, Mwacharo J, Kai O, Mwangi T, Milligan P, Todryk S, et al. A phase 2b randomised trial of the candidate malaria vaccines FP9 ME-TRAP and MVA ME-TRAP among children in Kenya. PLoS Clin Trials. 2006;1(6):e29.</p>\n <p>\n 5.         Bejon P, Peshu N, Gilbert SC, Lowe BS, Molyneux CS, Forsdyke J, et al. Safety profile of the viral vectors of attenuated fowlpox strain FP9 and modified vaccinia virus Ankara recombinant for either of 2 preerythrocytic malaria antigens, ME-TRAP or the circumsporozoite protein, in children and adults in Kenya. Clin Infect Dis. 2006;42(8):1102-10.</p>\n <p>\n 6.         Moorthy VS, Imoukhuede EB, Milligan P, Bojang K, Keating S, Kaye P, et al. A randomised, double-blind, controlled vaccine efficacy trial of DNA/MVA ME-TRAP against malaria infection in Gambian adults. PLoS Med. 2004;1(2):e33.</p>\n <p>\n 7.         Moorthy VS, Pinder M, Reece WH, Watkins K, Atabani S, Hannan C, et al. Safety and immunogenicity of DNA/modified vaccinia virus ankara malaria vaccination in African adults. J Infect Dis. 2003;188(8):1239-44.</p>\n <p>\n 8.         Reyes-Sandoval A, Sridhar S, Berthoud T, Moore AC, Harty JT, Gilbert SC, et al. Single-dose immunogenicity and protective efficacy of simian adenoviral vectors against Plasmodium berghei. Eur J Immunol. 2008;38(3):732-41.</p>\n <p>\n 9.         Sridhar S, Reyes-Sandoval A, Draper SJ, Moore AC, Gilbert SC, Gao GP, et al. Single-dose protection against Plasmodium berghei by a simian adenovirus vector using a human cytomegalovirus promoter containing intron A. J Virol. 2008;82(8):3822-33.</p>\n <p>\n 10.       Webster DP, Dunachie S, Vuola JM, Berthoud T, Keating S, Laidlaw SM, et al. Enhanced T cell-mediated protection against malaria in human challenges by using the recombinant poxviruses FP9 and modified vaccinia virus Ankara. Proc Natl Acad Sci U S A. 2005;102(13):4836-41.</p>\n <p>\n 11.       Ewer KJ, O'Hara GA, Duncan CJ, Collins KA, Sheehy SH, Reyes-Sandoval A, et al. Protective CD8+ T-cell immunity to human malaria induced by chimpanzee adenovirus-MVA immunisation. Nat Commun. 2013;4:2836.</p>\n <p>\n 12.       Ogwang C, Kimani D, Edwards NJ, Roberts R, Mwacharo J, Bowyer G, et al. Prime-boost vaccination with chimpanzee adenovirus and modified vaccinia Ankara encoding TRAP provides partial protection against Plasmodium falciparum infection in Kenyan adults. Sci Transl Med. 2015;7(286):286re5.</p>\n <p>\n  </p>\n <p>\n  </p>\n</div>\n<p>\n  </p>\n
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        • id177
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        • given_nameCaroline
        • middle_nameAmolo
        • family_nameOgwang
        • qualificationMedical Officer, MBChB
        • professional_addressP.O. BOX 230-80108, KILIFI.
        • telephone(+254)417522535
        • emailcogwang@kemri-wellcome.org
        • created2013-12-19 10:53:20
        • modified2020-08-10 10:40:25
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        • id143
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        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personRachel Roberts
        • addressCentre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Oxford. OX3 7L, United Kingdom.J
        • telephone_number+44(0)1865 857401
        • fax_number
        • cell_number+44(0)1865 857418
        • email_addressrachel.roberts@ndm.ox.ac.uk
        • created2013-12-19 10:53:20
        • modified2020-08-10 10:40:25
  • 4(array)
    • Application(array)
      • id1212
      • user_id567
      • trial_status_id6
      • abstract_of_study<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><b><span lang=\"EN-US\" style=\"line-height: 17.12px;\">Background</span></b></span></span><b><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></b></p>\n<p class=\"BodyText12\" style=\"margin: 0cm 0cm 12pt; text-align: justify; line-height: 17.6px; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\">At the end of December 2021, 68% of PLHIV globally had achieved virological suppression against the UNAIDS target of 95%. Virologic suppression is primarily dependent on adherence to antiretroviral therapy (ART). Simplifying treatment and overcoming the need for daily pill taking is an important step in increasing treatment compliance, improving quality of life and reducing the death and disability caused by HIV treatment failure. Long-acting (LA) injectable therapy offers a greatly reduced dosing frequency that may be a better option for patients with a history of sub-optimal adherence as it may result in reduced stigma, improved adherence and greater treatment satisfaction.</span></span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p class=\"BodyText12\" style=\"margin: 0cm 0cm 12pt; text-align: justify; line-height: 17.6px; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\">This study will build upon data provided by the ongoing Cabotegravir (CAB) and Rilpivirine (RPV) Efficacy and Safety (CARES) study in Uganda, Kenya, and South Africa that aims to determine whether the antiviral effect of switching to injectable cabotegravir and rilpivirine is non-inferior to continuation of first-line ART in virologically suppressed PLHIV.</span></span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><b><span lang=\"EN-US\" style=\"line-height: 17.12px;\">Methods</span></b></span></span><b><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></b></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">This is a randomized, open-label multicenter, interventional study of 540 virologically suppressed (HIV-1 VL <200 c/mL) HIV-1 infected adults (18 years or older) who have a history of, or are at high risk of, sub-optimal adherence to daily oral ART and/or engagement in HIV care.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">The study will take place in Kenya, Uganda and South Africa. In Kenya, 160 participants will be enrolled into the study, 80 each at Kenyatta National Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital. Participants will be randomized 1:1 to continue daily oral ART or switch to LA CAB / RPV, and will be followed for 24 months.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">HIV-1 RNA viral load will be measured at months 2/3, 6, 8/9, 12 18 and 24. CD4 count, complete blood count,</span><span class=\"NoneA\"><span lang=\"EN-US\"> </span></span><span lang=\"EN-US\" style=\"line-height: 17.12px;\">renal and liver function tests, glycated haemoglobin, fasting lipids, urinalysis and patient satisfaction will be measured at baseline and during follow up, along with other safety investigations. Procedures to minimize risk of COVID-19 infection amongst participants and staff will be implemented.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">The primary efficacy endpoint of virologic response (HIV-1 RNA <50 copies/ml at 12 months) will be analysed for non-inferiority using the FDA snapshot method.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><b><span lang=\"IT\" style=\"line-height: 17.12px;\">Conclusion</span></b></span></span><b><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></b></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">The results of this study will establish whether LA injectable therapy is an effective treatment option for PLHIV with a history of sub-optimal ART adherence or engagement in care.</span></span></span></p>\n
      • study_title<p>\n Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV-1 Control in Sub-Saharan Africa: A Pragmatic Phase 3b Open-Label Randomized Controlled Trial</p>\n
      • laymans_summary<p align=\"center\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV-1 Control in Sub-Saharan Africa: A Pragmatic Phase 3b Open-Label Randomized Controlled Trial</strong></span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Background: </strong>At the end of December 2021, only 2 out of 3 people living with HIV (PLHIV) had achieved viral suppression which means there was control of the amount of HIV virus in their blood. Internationally, the goal is to have 95% of PLHIV being virally suppressed. The main driver to successful HIV treatment and control is taking medication as per the instructions of the healthcare providers. Simplifying treatment and overcoming the need for daily pill taking is an important step in making it easier to take medication correctly. This will also improve the quality of life and reduce the death and disability caused by HIV treatment failure. Monthly or 2-monthly injectable drugs offer a greatly reduced dosing frequency. This dosing plan may be a better option for patients who find it difficult to take medication as prescribed and it may result in reduced stigma and greater treatment satisfaction.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">This research will build upon data provided by the ongoing Cabotegravir (CAB) and Rilpivirine (RPV) Efficacy and Safety (CARES) study in Uganda, Kenya, and South Africa that aims to determine whether the injectable HIV-1 drugs are as good as the current oral drugs in controlling the amount of HIV virus in PLHIV.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Objective: </strong>We would like to determine if changing to 2-monthly injections of the drugs CAB and RPV is as good as continuing on the current recommended daily oral antiretrovirals over a 12-month period in PLHIV who have in the past had difficulty in taking their medication as prescribed or had difficulty in engaging in care.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Participants and Methods: </strong>We will enroll 540 participants in 3 countries: Kenya, Uganda and South Africa. In Kenya, a total of 160 participants will be recruited from HIV clinics at Kenyatta National Hospital in Nairobi and Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu, 80 at each site. After providing written informed consent, participants will be evaluated for eligibility for up to 3 months. Thereafter, half of them will have their HIV treatment changed to 2-monthly injectable treatment while the other half will remain on the treatment they have been using; this choice will be made randomly at the time each person is enrolled onto the study. Thereafter, each person will be followed up for 24 months. During this time, the amount of HIV virus in blood will be checked on months 2/3, 6, 8/9, 12, 18 and 24 alongside other laboratory and radiological tests assessing for safety. Procedures to minimize risk of COVID-19 infection amongst participants and staff will be implemented.</span></span></p>\n
      • short_titleIMPALA Study
      • protocol_noECCT/23/01/05
      • version_noAmendment-1
      • date_of_protocol30-09-2022
      • study_drugCabotregavir and Rilpivirine
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVocabria/Rekambys/Edurant
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name2 NRTIs (TDF and 3TC) plus INSTI (DTG)
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDR LOICE ACHIENG OMBAJO
      • declaration_date125-01-2023
      • declaration_principal_investigatorDR LOICE ACHIENG OMBAJO
      • declaration_date225-01-2023
      • placebo_presentNo
      • study_objectives<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">Primary Obective:</span></strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">To demonstrate the non-inferior efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long acting (LA) plus rilpivirine (RPV) LA compared with continuation of daily oral ART over 12 months in people living with HIV-1 (PLHIV1) with a history of, or at risk of, sub-optimal ART adherence or engagement in care.</span></span></span></p>\n<p>\n  </p>\n<p>\n <strong><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">Secondary Objectives:</span></span></span></strong></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To demonstrate the antiviral activity and the impact on retention in HIV care of switching to Q2M CAB LA + RPV LA compared with continuation of daily oral ART over 12 and 24 months in PLHIV1 with a history of, or at risk of, sub-optimal ART adherence or engagement in care</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To demonstrate the immunological activity of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To evaluate the safety and tolerability of switching to Q2M CAB LA + RPV LA compared to continuation of daily oral ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess genotypic viral resistance in participants experiencing protocol-defined CVF (confirmed plasma HIV-1 RNA ≥200 c/mL on 2 consecutive tests) and its impact on future treatment options including proportion who resuppress on dolutegravir</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To evaluate the effect of Q2M CAB LA + RPV LA on health-related quality of life</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess treatment satisfaction</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess preference for Q2M CAB LA + RPV LA compared to daily oral ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To measure participants' medical resource utilization under Q2M CAB LA + RPV LA compared to daily oral ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess programmatic acceptability of Q2M CAB LA + RPV LA</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To evaluate adherence to treatment</span></span></li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">18 years of age and above</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV-1 infection confirmed in clinic records or by study tea,</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Two consecutive HIV-1 VL <200 copies/ml ≥3 months apart prior to randomization</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">On an oral regimen of 2NRTI + DTG as part of first-line ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Is identified as a participant with a history of sub-optimal ART adherence or engagement in care</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">A female participant is eligible to participate if she is not pregnant, not lactating, and either has non-reproductive potential of if has reproductive potential, agrees to to a highly effective method of avoiding pregnancy from 30 days prior to the first dose of study medication</span></span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">Male partidcipants are advised to wear a condim during sexual intercourse</span></span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">Must sign informed consent form </span>indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">Willing and able to attend all clinic appointments</span></span></span></li>\n</ol>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">For more details, see section 5.1 of the protocol (pages 31 to 33)</span></span></span></p>\n
      • principal_exclusion_criteria<ol>\n <li>\n Not virologically suppressed (VL <200c/ml) for ≥3 months at the end of the screening process</li>\n <li>\n Previous use, or intention to use, protease inhibotor-based ART at any time</li>\n <li>\n Evidence of prior HIV-1 resistance test with NNRTI drug resistance mutations (other than K103N) and/or INSTI drug resistance mutations</li>\n <li>\n Unwillingness to receive 2 injections on a 2-monthly basis</li>\n <li>\n Unwilling to use a form of contraception</li>\n <li>\n Pregnant, breastfeeding or planning to become pregnant during the study period</li>\n <li>\n Requires tuberculosis therapy or other drug with clinically relevant drug interaction </li>\n <li>\n High risk of seizures, including participants with an unstable or poorly controlled seizure disorder</li>\n <li>\n Has active TB or other mycobacterial disease and requires treatment</li>\n <li>\n Advance liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or assymptomatic gallstones) or history of cirrhosis</li>\n</ol>\n<p>\n <span style=\"font-family: arial, helvetica, sans-serif;\">For more details, see section 5.2 of the protocol (pages 33 to 35)</span></p>\n
      • primary_end_points<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\" style=\"color: rgb(0, 0, 0);\">Proportion with plasma HIV-1 viral load (VL) <50 c/mL at 12 months (by Food and Drug Administration [FDA] snapshot algorithm)</span></span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</strong></p>\n<p>\n Kenyatta National Hospital Comprehensive Care Centre (CCC) was established in December 2002 as the pioneer care and treatment centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS), Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs, and the Center for International Health, Education, and Biosecurity (CIHEB) - Kenya. It has evolved over time to be a centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  </p>\n<p>\n The CCC offers a one-stop-shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.</p>\n<p>\n  The services offered at the Comprehensive Care Centre include the following:</p>\n<p style=\"margin-left:36.75pt;\">\n 1.     Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co-morbidities</p>\n<p style=\"margin-left:36.75pt;\">\n 2.     Anti-Retroviral Therapy both 1^st line; 2^nd line and 3^rd line regimens as per the WHO guidelines</p>\n<p style=\"margin-left:36.75pt;\">\n 3.     Laboratory monitoring and evaluation of the patients - The centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Flow Cytometry </p>\n<p style=\"margin-left:72.75pt;\">\n ·       Hematology </p>\n<p style=\"margin-left:72.75pt;\">\n ·       Chemistry </p>\n<p style=\"margin-left:72.75pt;\">\n ·       TB Diagnosis </p>\n<p style=\"margin-left:72.75pt;\">\n ·       HIV EID </p>\n<p style=\"margin-left:72.75pt;\">\n ·       HIV Viral Load </p>\n<p style=\"margin-left:36.75pt;\">\n 4.     Research: Since its inception the centre has actively been involved in research which has informed HIV/AIDS national policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with international partners include: </p>\n<p style=\"margin-left:72.75pt;\">\n ·       A clinical trial with almost 400 participants at the site to determine the efficacy of a switch to DTG-based ART from the standard PI/r-based ART for PLHIV on second-line ART</p>\n<p style=\"margin-left:72.75pt;\">\n ·       A clinical trial with over 300 participants evaluating the effectiveness of switching older PLHIV on first-line ART to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF)</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Optimizing Pediatric HAART Study</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic</p>\n<p style=\"margin-left:36.75pt;\">\n 5.     Training of undergraduate and postgraduate students in the departments of Clinical Medicine and Therapeutics and Pediatrics and Child Health at the University of Nairobi</p>\n<p style=\"margin-left:36.75pt;\">\n 6.     Adherence Counseling</p>\n<p style=\"margin-left:36.75pt;\">\n 7.     Nutritional Counseling</p>\n<p style=\"margin-left:36.75pt;\">\n 8.     Social Work Support</p>\n<p style=\"margin-left:36.75pt;\">\n 9.     Physiotherapy services</p>\n<p style=\"margin-left:36.75pt;\">\n 10.  Supportive Counseling</p>\n<p>\n  </p>\n<p>\n The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9,400 with 8,150 on first-line regimens and 1,230 on second-line regimens and 20 patients on third-line regimens. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the CCC. With the experience of the staff working in the CCC and the high number of patients including those with history of sub-optimal adherence to treatment and/or care, the KNH Comprehensive Care Centre is best suited to undertake this research study.</p>\n<p>\n <strong>CAPABILITY STATEMENT FOR JOOTRH TO CONDUCT CLINICAL RESEARCH</strong></p>\n<p>\n Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. </p>\n<p>\n The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). </p>\n<p>\n JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and Rift Valley with a population of more than 7 million people. It has a bed capacity of 530. </p>\n<p>\n The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. </p>\n<p>\n It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. </p>\n<p>\n The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as on 1st June 2019.</p>\n<p>\n JOOTRH Patient Support Centre (PSC) was started in the year 2002 and has ever enrolled approximately 28,000 clients. Current active on care is 6,842 by the end of June 2019. Total number of clients on first-line are 6,203, on second-line are 600, and 11 clients are on third-line. </p>\n<p>\n Out of the 154 staff employed by the CDC-funded implementing partner at the site, 39 are stationed at the PSC and 6 are MOH staff. There is 1 medical officer, 1 pharmacist, 8 nurses, 7 clinical officers, 3 pharmaceutical technologists, 2 social workers, 4 adherence councilors, 8 peer educators, 3 health records information officers, 5 data clerks, 1 nutritionist and 1 laboratory technician. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the PSC.</p>\n<p>\n The daily workload of the clinic is between 250 to 300 per regular clinic day (Monday, Tuesday and Friday) comprising adults 35 years old and above. 180 to 250 youths are seen on Wednesday (youth day age 20- 35 yrs) and 70 to 150 adolescents are seen on Thursdays.</p>\n<p>\n The CCC also runs viremia clinics for patient with high viral loads on first-line therapy every Wednesday while Fridays are reserved for clients failing second-line treatment.</p>\n<p>\n The medical officer is the in-charge of the clinic and works closely with the matron and the pharmacist in charge of the PSC Pharmacy. </p>\n<p>\n The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. </p>\n<p>\n JOOTRH is also the hub center for the regional Nyanza-Western technical working group meetings held every 2^nd Monday of the month. It is also the spokes hub for ECHO sessions held every Thursday at 3pm.</p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n The sites in South Africa are making a similar application to the South African Health Products Regulatory Authority. The sites in South Africa are Caprisa and Desmond Tutu.</p>\n
      • other_details_regulatory_approved<p>\n National Drug Authority in Uganda; Date of approval is 7th November 2022; Number of sites is 4 (Entebbe Hospital, Joint Clinical Research Centre in Lubowa, Joint Clinical Reserach Centre in Fort Portal, and Infectious Diseases Institute in Kampala)</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration3 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
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      • design_controlled_comparator2 NRTIs + DTG
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      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
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      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites2
      • multi_country_listUganda, South Africa and Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site80 at KNH and 80 at JOOTRH
      • total_participants_worldwide540
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
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      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_nameAchieng
      • investigator1_family_nameOmbajo
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants160
      • notification
      • approval_date14-03-2023
      • submitted1
      • deleted0
      • deleted_date(null)
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      • date_submitted25-01-2023
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      • balance_site(null)
      • final_date(null)
      • modified2025-03-05 15:12:20
      • created2023-01-19 08:09:40
      • total_sites(null)
      • ecitizen_invoice321010
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        • professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2023-01-19 08:42:43
        • modified2023-01-25 15:38:14
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        • contact_detailsP.O. Box 20723 - 00202, Nairobi
        • contact_personDr Loice Achieng Ombajo
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        • created2023-01-19 08:42:43
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          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
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        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressPatient Support Centre, Jomo Kenyatta Highway, Kaloleni, Kisumu
        • contact_detailsP.O. Box 849 - 40100, Kisumu
        • contact_personDr Florentius Ndinya
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        • created2023-01-19 10:31:11
        • modified2023-01-25 15:38:14
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id629
        • application_id1212
        • sponsorUniversity of Nairobi
        • sponsor_typeResearch Institution
        • contact_personProf Erastus Amayo
        • addressP.O. Box 19676 - 00202 Nairobi, Kenya
        • telephone_number+254204915041
        • fax_number
        • cell_number+254733611557
        • email_addresserastus.amayo@uonbi.ac.ke
        • created2023-01-19 08:42:43
        • modified2023-01-25 15:38:14
      • 1(array)
        • id633
        • application_id1212
        • sponsorLondon School of Hygiene and Tropical Medicine
        • sponsor_typeResearch Institution
        • contact_personFiona Cresswell
        • addressKeppel Street, London, WC1E 7HT, United Kingdom
        • telephone_number+44 (0)20 7636 8636
        • fax_number
        • cell_number+254769080859
        • email_addressFiona.Cresswell@lshtm.ac.uk
        • created2023-01-24 11:07:28
        • modified2023-01-25 15:38:14
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PHP Environment

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