Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Intervention: Ad26.ZEBOV; MVA-BN-Filo; MenACWY; Placebo
Intervention description: Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.; MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).; MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.; 0.9% saline for injection.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1023.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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)

Summary:

      The purpose of this study is the evaluation of the safety and immunogenicity of two candidate
      Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.
    

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)