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
- Conditions
- Ebola
- Registration Number
- PACTR201506001147964
- Lead Sponsor
- Janssen Vaccines and Prevention B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1020
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stage 1: Number of Participants with Adverse Events;Stage 2: Number of Participants with Adverse Events;Stage 1: Number of Participants with Serious Adverse Events;Stage 2: Number of Participants with Serious Adverse Events;Stage 1 and 2: Number of Participants with Solicited Local and Systemic Adverse Events<br>
- Secondary Outcome Measures
Name Time Method Stage 1: Number of Participants with Adverse Events After the Third Vaccination;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