Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo (EBOVAC-Salone)
Ebola Virus Disease
About this trial
This is an interventional prevention trial for Ebola Virus Disease focused on measuring Vaccine, Ebola, Ebola virus disease, EVD, Hemorrhagic fever, Sierra Leone, Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Safety, Immunogenicity, Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector, (MVA-BN Filo)
Eligibility 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 Stage 1 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
- Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination
- Female participants 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:
- Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of >= 38 degree Celsius (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 Dose 1 vaccination
- Treated with an immunosuppressive drug at the time of screening
Additional exclusion criteria:
- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Stage 1: Active vaccination
Stage 2: Active vaccination
Stage 2: Active vaccination for children
Stage 2: Control vaccination
Stage 2: Control vaccination for children
Ad26.ZEBOV will be administered as a 0.5 milliliter (mL) intramuscular (IM) injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). The booster vaccination using Ad26.ZEBOV will be administered as a 0.5 mL IM injection (2 years post Dose 1).
Ad26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2).
Ad26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of vaccination at 3 months post Dose 2 with Placebo.
MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2).
MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of MenACWY vaccination at 3 months post Dose 2 with MenACWY.