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.: PACTR202002606736841 Date of Approval: 12/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title VAC52150EBL2002: Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults
Official scientific title A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
Brief summary describing the background and objectives of the trial The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 28/09/2015
Actual trial start date 06/11/2015
Anticipated date of last follow up 18/02/2019
Actual Last follow-up date 12/02/2019
Anticipated target sample size (number of participants) 1056
Actual target sample size (number of participants) 1075
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NCT02564523 US - NIH
201900069022 EMA - EudraCT
VAC52150EBL2002 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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 1 year Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). 462
Experimental Group Group 2 1 year Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 57) or placebo (Day 1/Day 57) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). 462
Experimental Group Group 3 1 year Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 85) or placebo (Day 1/Day 85) 132
Control Group No Intervention 1 year No intervention 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For healthy adults and elderly participants: *Must be healthy in the investigator’s clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination & vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if hemoglobin is above the age/gender specific limits *Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening & immediately prior to each study vaccination *A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening *Must pass the test of understanding (TOU) *Must be available & willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants *Must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening *Must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening & having a CD4 positive cell count of >350 cells/micoliter. Also participant must be in an otherwise reasonable good medical condition Additional Inclusion Criteria Children Participants *Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents & older children, depending on local regulations and practice. *Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive) *Pediatric participants must have received all routine immunizations appropriate for his/her age as reported by parent(s)/legal guardian, according to local routine vaccination schedule *Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening *Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past *Having HIV type 1 or type 2 infection (for healthy adults/elderly/children) *Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds) *A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination *For HIV+ adults, no AIDS-defining illnesses Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 4 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 12/06/2015 Comite Instutionnel De Bioethique du Centre National De Recherche et de Formation sure le Paludisme
Ethics Committee Address
Street address City Postal code Country
Ouagadougou 01 Ouagadougou 0000 Burkina Faso
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 04/08/2015 Comite National Dethique et de la Recherche
Ethics Committee Address
Street address City Postal code Country
Institut Pasteur - Chu de Cocody Abidjan 0000 Cote Divoire
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 29/07/2015 Uganda Virus Research Institute IRB
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road Entebbe 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 30/10/2015 KNH UON ERC Kenyatta National Hospital
Ethics Committee Address
Street address City Postal code Country
Hospital Road Nairobi 0000 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 19/08/2015 Faculty of Medicine Research and Ethics Committee Makerere University College of Health Sciences
Ethics Committee Address
Street address City Postal code Country
Nakasero Road Kampala 0000 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of Participants With Adverse Events Up to 42 plus/minus 3 days post last vaccination
Primary Outcome Number of Participants With Serious Adverse Events Continuous throughout the duration of the study up to Day 365 plus/minus 1 month
Primary Outcome Number of Participants with Solicited Local and Systemic Adverse Events Up to 7 days after each study vaccination
Secondary Outcome Antibody levels against the EBOV GP measured by an enzyme-linked immunosorbent assay (ELISA) At 21 days post boost vaccination
Secondary Outcome Number of Participants With Adverse Events as a Measure of Safety and Tolerability of a Third Vaccination With Ad26.ZEBOV Up to 28 Days after third vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre MURAZ Avenue Mamadou Konate BoboDioulasso Burkina Faso
Centre National de Recherche et de Formation sur le Paludisme Avenue Kumda Yonre Ouagadougou Burkina Faso
Centre Hospitalier Universitaire de Treichville No street address Abidjan Cote Divoire
Centre Medical SAPH Toupah No street address Toupah Cote Divoire
KAVI Institute of Clinical Research University of Nairobi Nairobi Kenya
Medical Research Council Uganda Virus Research Institute Research Unit on AIDS Nakiwogo Road Entebbe Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Innovative Medicines Initiative Avenue de la Toison dOr 56-60 Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Vaccines and Prevention B.V. Newtonweg Leiden Netherlands Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
EBOVAC2 Consortium Partner Inserm 101 rue de Tolbiac Paris 75013 France
Le centre Muraz Avenue Mamadou Konate BoboDioulasso 001390 Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Michael Katwere mkatwere@its.jnj.com +256414237707 Plot 26 Nakasero Road
City Postal code Country Position/Affiliation
Kampala 23186 Uganda Medical department Janssen
Role Name Email Phone Street address
Public Enquiries Michael Katwere mkatwere@its.jnj.com +256414237707 Plot 26 Nakasero Road
City Postal code Country Position/Affiliation
Kampala 23186 Uganda Medical department Janssen
Role Name Email Phone Street address
Principal Investigator Houreratou Barry houreratou@yahoo.fr +22666558156 Avenue Mamadou Konate
City Postal code Country Position/Affiliation
Bobodioulasso 0000 Burkina Faso Principal Investigator Centre Muraz
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu URL: https://www.janssen.com/clinical-trials/transparency Study Protocol The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu URL: https://www.janssen.com/clinical-trials/transparency The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu URL: https://www.janssen.com/clinical-trials/transparency
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.janssen.com/clinical-trials/transparency Yes 11/12/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/12/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information