Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: info@nhrec.ne Trial No: 39808518 Date registered: 2017-09-18 Trial Status: Pending TRIAL DESCRIPTION Public title 202091 (EBOLA Z CHAD3-005):Safety and immunogenicity study of GSK Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (GSK3390107A) in adults in Africa Official scientific title 202091 (EBOLA Z CHAD3-005): A Phase 2, randomised, observer-blind, placebo-controlled, multi-country study to assess the safety and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), in adults 18 years of age and older in Africa. Brief summary describing the background and objectives of the trial Using the investigational EBOV vaccine encoded by chimpanzee-derived adenovirus (ChAd3-EBO-Z) dose selected during the Phase 1 stage, the present Phase 2, randomised, placebo-controlled trial will aim at collecting robust safety and immunogenicity data following a single intramuscular (IM) dose of the investigational ChAd3-EBO-Z vaccine. Type of trial Prevention Acronym (If the trial has an acronym then please provide) Safety and immunogenicity study of GSK Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (GSK3390107A) in adults in Africa Disease(s) or condition(s) being studied Ebola Purpose of the trial Anticipated trial start date 2015-07-01 Actual trial start date 2015-07-15 Anticipated date of last follow up 2016-03-22 Actual date of last follow up 2016-12-23 Anticipated target sample size (number of participants) 3000    Actual target sample size (number of participants) 3000    Recruitment status Not yet recruiting No Secondary ID Issuing authority/Trial register 1 NHREC/01/01/2007 NHREC 2 NAFDAC/DER/CT/GSK/EBOLA/2015 NAFDAC STUDY DESIGN Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1 INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Experimental group ChAd3-EBO-Z vaccine 1 to 2 ml day 0 and month 6 intramascular injection 1500 Active Control group Placebo 1 to 2 ml day 0 and month 6 intramascular injection 1500 Placebo ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 1 1 1 1 1 ETHICS APPROVAL Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee 0000-00-00 2015-04-20 JUTH Ethics Committee Ethics Committee Address Street address City Postal code Country Josh University Teaching Hospital Jos 930001 Nigeria 0000-00-00 2015-05-20 National Health Research Ethics Committee of Nigeria (NHREC) Ethics Committee Address Street address City Postal code Country Federal Secretariat Complex Shehu Shagari Way Abuja 0 Nigeria OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Primary Outcome Drops from baseline platelets levels were observed in both groups without notable differences, and no clinical sign of thrombocytopenia (AESI) was reported within the first 7 days post Day 0 vaccinati Final Results summary dated 30 Nov 2017 RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country Walter Reed Program Nigeria 7 Usama Street, Off Gana Street Maitama, Abuja 90271 Nigeria Jos University Teaching Hospital/APIN Murtala Muhammed Road, Old JUTH Campus Jos 930001 Nigeria FUNDING SOURCES Name of source Street address City Postal code Country GlaxoSmithKline (GSK) Rue de l’institut 89 Rixensart 1330 Belgium SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor Primary Sponsor GlaxoSmithKline Biologicals Rue de l’institut 89, Rixensart 1330 Belgium Company COLLABORATORS Name Street address City Postal code Country N/A N/A N/A 0 Belgium CONTACT PEOPLE Role Name Email Phone Fax Principal Investigator Prof Stephen Oguche danielle.erasmus@quintiles.com 0 2147483647 Street address City Postal code Country Position / Affiliation Murtala Muhammed Road Jos 1330 Nigeria Principal Investigator Principal Investigator Dr Babajide Keshinro danielle.erasmus@quintiles.com 0 2147483647 Street address City Postal code Country Position / Affiliation 7 Usama Street Abuja 1330 Nigeria Principal Investigator Public Enquiries Mrs Karen Bester karen.bester@quintiles.com 27 27 Street address City Postal code Country Position / Affiliation Montrose Place, 2 Bella Rosa Street Bellville 7530 South Africa Regulatory and Start-up Manager Quintiles Scientific Enquiries Prof Abdi Naficy abdi.naficy@quintiles.com 0 0 Street address City Postal code Country Position / Affiliation 3-5, rue Maurice Ravel Levallois-Perret Cedex 92594 France Medical Director Quintiles