Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201506001147964 Date of Approval: 25/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Staged Phase 3 study to assess the safety and immunogenicity of Ebola candidate vaccines Ad26.ZEBOV and MVA-BN-Filo during implementation stage 1 and 2
Official scientific title A Staged Phase 3 Study, Including a Double-blind controlled stage to evaluate the safety and immunogenicity of Ad26 ZEBOV and MVA-BN-Filo as candidate prophylactic vaccines for Ebola
Brief summary describing the background and objectives of the trial The purpose of this study is the evaluation of the safety and immunogenicity, during the implementation of Stages 1 and 2 of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EBOVAC Salone
Disease(s) or condition(s) being studied Ebola,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention
Anticipated trial start date 22/06/2015
Actual trial start date 30/09/2015
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 03/07/2019
Anticipated target sample size (number of participants) 1020
Actual target sample size (number of participants) 1023
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
VAC52150EBL3001 Janssen Vaccines and Prevention BV
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Stage 1 Active vaccination Ad26 ZEBOV MVA BN Filo 0.5 millilitre (mL) intramuscular (IM) injection • Ad26.ZEBOV – Day1 (Dose1) • MVA-BN-Filo – Day57 (Dose2) • Ad26.ZEBOV – 2 years post Day1 (Dose3) • Ad26.ZEBOV – Ebola Zaire vaccine, live, replication incompetent vaccine, sterile suspension of 0.5 millilitre (mL) intramuscular (IM) injection of 5*10^10 viral particles. • MVA‐BN‐Filo – Live Replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.) 40 Uncontrolled
Control Group Stage 2 Control vaccination MenACWY Placebo 0.5 millilitre (mL) intramuscular (IM) injection • MenACWY – Day1 (Dose1) • Placebo – Day57 (Dose2) • MenACWY – WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine. • Placebo – 0.9% saline for injection 100 Active-Treatment of Control Group
Experimental Group Stage 2 Active vaccination Ad26 ZEBOV MVA BN Filo 0.5 millilitre (mL) intramuscular (IM) injection • Ad26.ZEBOV – Day1 (Dose1) • MVA-BN-Filo – Day57 (Dose2) • Ad26.ZEBOV – Ebola Zaire vaccine, live, replication incompetent vaccine, sterile suspension of 0.5 millilitre (mL) intramuscular (IM) injection of 5*10^10 viral particles. • MVA‐BN‐Filo – Live Replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.) 300 Active-Treatment of Control Group
Experimental Group Stage 2 Active vaccination for children Ad26 ZEBOV MVA BN Filo Placebo 0.5 millilitre (mL) intramuscular (IM) injection • Ad26.ZEBOV – Day1 (Dose1) • MVA-BN-Filo – Day57 (Dose2) • Placebo – 3 months post Day57 vaccine (only for <2 years old participant; Dose3) • Ad26.ZEBOV – Ebola Zaire vaccine, live, replication incompetent vaccine, sterile suspension of 0.5 millilitre (mL) intramuscular (IM) injection of 5*10^10 viral particles. • MVA‐BN‐Filo – Live Replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.). • Placebo – 0.9% saline for injection 432
Control Group Stage 2 Control vaccination for children MenACWY Placebo 0.5 millilitre (mL) intramuscular (IM) injection • MenACWY – Day1 (Dose1) • Placebo – Day57 (Dose2) • MenACWY – 3 months post Day57 vaccine (only for <2 years old participant; Dose3) • MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine. • Placebo – 0.9% saline for injection 144 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria Stage 1 and 2 - Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available - Participant must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months (or during the entire study duration for stage 2) - Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before prime vaccination - Female subjects of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination - Participant must pass the test of understanding (TOU) Additional Inclusion criteria Stage 2 - One year or older at screening (children of enrolled parents are eligible) - Parent/legal guardian (for children) must pass the TOU before signing the ICF - Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness Exclusion criteria Stage 1 and 2 - Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of greater than 38.00C (fever) - Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia) - Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine - Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before prime vaccination - Treated with an immunosuppressive drug at the time of screening Additional exclusion criteria for stage 2 -Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 100 Year(s) Both
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
Yes 09/06/2015 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Youyi Building, Brookfields Freetown 00000 Sierra Leone
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/02/2016 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Youyi Building, Brookfields Freetown 00000 Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stage 1: Number of Participants with Adverse Events From signing informed consent form till 56 days after the boost vaccination approximately 156 days
Secondary Outcome Stage 1: Number of Participants with Adverse Events After the Third Vaccination From day of third vaccination till 28 days post third vaccination approximately 28 days
Primary Outcome Stage 2: Number of Participants with Adverse Events From signing ICF till 28 days post-prime and 28 days post-boost vaccination approximately 79 days
Primary Outcome Stage 1: Number of Participants with Serious Adverse Events From signing ICF till 36 months post prime approximately up to 38 months
Primary Outcome Stage 2: Number of Participants with Serious Adverse Events From signing ICF till 2 years post-prime in stage 2 approximately up to 2 years and 1 month
Primary Outcome Stage 1 and 2: Number of Participants with Solicited Local and Systemic Adverse Events Up to 7 days after each vaccination
Secondary Outcome Stage 1 and 2: Serum Concentration of Antibodies Binding to EBOV GP Measured by an Enzyme-linked Immunosorbent Assay ELISA at 21 Days Post-boost Vaccination At 21 days post-boost vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mission House (Kambia 1) * Mission House, Kambia Sierra Leone
Kambia 2 33A Katimpe Road Kambia Sierra Leone
EBOVAC Salone Clinic Rokupr Kambia 00000 Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
IMI-2 Ebola program, Grant Agreement No 115854 EBOVAC1 Avenue de la Toison d'Or 56-60 Brussels B-1060 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Vaccines and Prevention B.V. Archimedesweg 4 Leiden Netherlands Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
The London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
College of Medicine and Allied Health Sciences (COMAHS) A. J. Momoh Street Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bailah Leigh bailahleigh@yahoo.co.uk +23276693102 College of Medicine and Allied Health Sciences, University of Sierra Leone
City Postal code Country Position/Affiliation
Freetown Sierra Leone
Role Name Email Phone Street address
Public Enquiries Thomas Mooney Thomas.mooney@lshtm.ac.uk 0000000000 LSHTM, Keppel Street, London, WC1E 7HT
City Postal code Country Position/Affiliation
London 00000 United Kingdom NA
Role Name Email Phone Street address
Scientific Enquiries Kim Offergeld kofferge@its.jnj.com +3114641846 Turnhoutseweg 30
City Postal code Country Position/Affiliation
Beerse 2340 Belgium GCDO Program Leader
Role Name Email Phone Street address
Scientific Enquiries Gibrilla Deen gibrilladeen1960@yahoo.com +23276865597 College of Medicine and Allied Health Sciences, University of Sierra Leone
City Postal code Country Position/Affiliation
Freetown Sierra Leone
REPORTING
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