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.: PACTR201608001734218 Date of Approval: 01/08/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety, Tolerability and Immunogenicity Study of 2-Dose Heterologous Regimens for Ebola vaccines Ad26.ZEBOV/MVA-BN-Filo
Official scientific title A Randomized, Observer-blind, Placebo-controlled, Two part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
Brief summary describing the background and objectives of the trial The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV infected adults. This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, 2-part, Phase 2 study Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In part 1, Dose-1 vaccination with MVA-Bn-Filo will be followed by Dose-2 vaccination with Ad26 14 days later in the US. In part 2, two regimens will be investigated. The first regimen will be Ad26 Dose-1 vaccination followed by MVA-BNFilo Dose-2 28 days later and the second regimen will be MVA-BN-Filo Dose-1 vaccination followed by MVA-BN-Filo Dose-1 14 days later in Africa. The study consists of a Screening phase of up to 8 weeks (starting from the moment the participants signs the ICF), a Vaccination Phase, in which participants will be vaccinated at baseline (Day 1) followed by a Dose-1 vaccination on Day 15 or 29, and a post-Dose-2 follow-up phase of maximum 1 year post-Dose-2 vaccination. Upon completion of 6-month Dose-2 boost visit those participants who received active vaccine will enter long-term follow-up until the 1 year post Dose-2 vaccination visit to assess long-term safety and immunogenicity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RV 456
Disease(s) or condition(s) being studied Ebola Vaccine,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 30/11/2015
Actual trial start date 10/12/2015
Anticipated date of last follow up 28/12/2018
Actual Last follow-up date 12/12/2018
Anticipated target sample size (number of participants) 575
Actual target sample size (number of participants) 578
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
VAC52150EBL2003 Janssen Vaccines and Prevention B.V.
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 randomisation using a computer software program Central randomization by computer software Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Part 1 US Participants MVA BN Filo Ad26 ZEBOV 0.5 millilitre (mL) intramuscular (IM) injection • MVA-BN-Filo - Day 1 (Dose1) • Ad26.ZEBOV - Day 15 (Dose2) • Ad26.ZEBOV - 5*10^10 viral particles • MVA-BN-Filo - 1*10^8 Infectious Unit 60 Active-Treatment of Control Group
Control Group Part 1 US Participants Placebo 0.5 millilitre (mL) intramuscular (IM) injection • Placebo - Day 1 (Dose1) • Placebo - Day 15 (Dose2) Placebo 0.9% saline for injection. 15 Placebo
Experimental Group Part 2 Group 1 African Participants Ad26 ZEBOV MVA BN Filo 0.5 millilitre (mL) intramuscular (IM) injection • Ad26.ZEBOV - Day 1 (Dose1) • MVA-BN-Filo - Day 29 (Dose2) • Ad26.ZEBOV - 5*10^10 viral particles • MVA-BN-Filo - 1*10^8 Infectious Unit 320
Control Group Part 2 Group 1 African Participants Placebo 0.5 millilitre (mL) intramuscular (IM) injection • Placebo - Day 1 (Dose1) • Placebo - Day 29 (Dose2) • Placebo - 0.9% saline for injection. 80 Placebo
Experimental Group Part 2 Group 2 African Participants MVA BN Filo Ad26 ZEBOV 0.5 millilitre (mL) intramuscular (IM) injection • MVA-BN-Filo - Day 1 (Dose1) • Ad26.ZEBOV - Day 15 (Dose2) • Ad26.ZEBOV - 5*10^10 viral particles • MVA-BN-Filo - 1*10^8 Infectious Unit 80
Control Group Part 2 Group 2 African Participants Placebo 0.5 millilitre (mL) intramuscular (IM) injection • Placebo - Day 1(Dose1) • Placebo - Day 15 (Dose2) • Placebo - 0.9% saline for injection. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Participant must be healthy in the Investigator’s clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening - Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study - A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG] pregnancy test immediately prior to each study vaccine administration - A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to Dose-1 vaccination until at least 3 months after the Dose-2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening - Participant must pass the test of understanding (TOU) - Additional Inclusion Criteria for HIV-infected participants a) participants must have a positive HIV-1 and/or -2 serology test within 6 months of screening, including the day of screening; b) participants must have a Screening CD4+ cell count >200 cells/microliter (mcL); c) in part 1, all participants must be on a stable highly active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part 2 participants with screening CD4+ cell count <350 cells/mcL must also be on a stable HAART regimen for 4 weeks prior to Screening - Has received any candidate Ebola vaccine - Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to Screening - Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to Screening - Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products - Presence of significant conditions (eg, history of seizure disorders, (auto) immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in participants >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 26/06/2016 National Health Research Ethics Committee of Nigeria NHREC
Ethics Committee Address
Street address City Postal code Country
Dept Health Planning, research and Statistics, Federal Ministry of Health, 11th Flr, Federal Secretariat Complex Phase III, Ahmadu Bello Way Abuja 900284 Nigeria
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 25/05/2016 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
PO Box 54840-00200 Nairobi 000000 Kenya
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 28/04/2016 Makarere University School of Public Health Higher Degrees Research and ethics Committee
Ethics Committee Address
Street address City Postal code Country
College of Health Sciences Kampala 00000 Uganda
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 23/08/2016 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 kimera Road Ntinda Kampala 0000 Uganda
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 20/10/2016 Mbeya Medical Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mbeya Consultant Hospital Mbeya 0000 Tanzania
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 15/09/2016 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Brack Obama Drive Dar es Salaam 0000 Tanzania
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 21/07/2016 National Bioethics Committee for Health CNBS
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Av Eduardo Mondlane Salvador Allende Maputo 0000 Mozambique
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of Participants with Adverse Events Up to Day 42 post-Dose-2 visit
Secondary Outcome Comparison of Safety and Tolerability of Ad26.ZEBOV/MVABN-Filo and MVA-BNFilo/Ad26.ZEBOV Regimens Between Healthy and HIV-Infected Adults Up to 1 year post Dose-2
Primary Outcome Number of Participants with Serious Adverse Events Continuous throughout the duration of the study up to 1 year post Dose-2 visit plus/minus 1 month
Primary Outcome Number of Participants with Solicited Local and Systemic Adverse Events Up to 7 days after each study vaccination
Primary Outcome Ebola Virus Glycoprotein (EBOV GP)-specific Antibody Concentrations measured by an enzyme-linked immunosorbent assay (ELISA) Up to day 21 after Dose-2 vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Clinical Research Centre Walter Reed Program Nigeria 7 Usuma Street Maitama Abuja 900271 Nigeria
Kenya Medical Research Institute Walter Reed Projec P.O. Box 1357, Hospital Road Kericho 20200 Kenya
Kenya Medical Research Institute Walter Reed Projec Off Kisumu Bondo Road Kombewa 40100 Kenya
Polana Canico Health Research and Training Center Av. Costa de Sol no178, Bairro da Polana Canico B Maputo Mozambique
NIMR Mbeya Medical Research Centre Hospital Hill Road, Mbeya Zonal Referral Hospital Mbeya Tanzania
Makerere University Walter Reed Project Plot 42, P. O. Box 16524, Nakasero Road Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen Vaccines & Prevention B.V Archimedesweg 4-6 2333 CN Leiden The Netherlands 2333 Netherlands
U.S. Military HIV Research Program (MHRP), Walter Reed Army Institute of Research (WRAIR) 6720A Rockledge Drive Suite 400 Bethesda MD 20817 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Vaccines & Prevention B.V Archimedesweg 4-6 2333 CN Leiden The Netherlands 2333 Netherlands Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
U.S. Military HIV Research Program (MHRP), Walter Reed Army Institute of Research (WRAIR) 6720A Rockledge Drive Suite 400 Bethesda MD 20817 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sawe Fredrick Fredrick.Sawe@usamru-k.org +254522036000 P.O. Box 1357 Hospital Road
City Postal code Country Position/Affiliation
Kericho 20200 Kenya Director KEMRI WRP Kericho
Role Name Email Phone Street address
Public Enquiries Melissa van Alst RA-RNDUS-ClinTriDisc@ITS.JNJ.com +31715242444 Archimedesweg 29
City Postal code Country Position/Affiliation
Leiden 2333 Netherlands Janssen Clinical Registry
Role Name Email Phone Street address
Scientific Enquiries Melissa van Alst RA-RNDUS-ClinTriDisc@ITS.JNJ.com +31715242444 Archimedesweg 29
City Postal code Country Position/Affiliation
Leiden 2333 Netherlands Janssen Clinical Registry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information