Ebola Ebola
Conditions
Interventions
Stage 1 Active vaccination Ad26 ZEBOV MVA BN Filo
Stage 2 Control vaccination MenACWY Placebo
Stage 2 Active vaccination Ad26 ZEBOV MVA BN Filo
Stage 2 Active vaccination for children Ad26 ZEBOV MVA BN Filo Placebo
Stage 2 Control vaccination for children MenACWY Placebo
Sponsors
Janssen Vaccines and Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sierra Leone
Contacts
Public ContactThomas Mooney
Outcome results
None listed