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
Condition: Hemorrhagic Fever, Ebola
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Intervention: Ad26.ZEBOV; MVA-BN-Filo; Placebo
Intervention description: One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles); One 0.5 mL IM injection of (1x10*8 infectious units); One 0.5 mL IM injection of 0.9% saline
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1075.0
Sex: All
Minimum age: 4 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Vaccine; Ebola viruses; Ebola virus disease (EVD); Filoviruses; Hemorrhagic fever; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector; Safety; Immunogenicity; Inserm, Centre Muraz

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Criteria for healthy adults and elderly participants:

          -  Participant must be healthy in the investigator's clinical judgment on the basis of
             clinical laboratory tests, medical history, ECG, physical examination and vital signs
             performed at screening. Participants with hemoglobin values outside the local
             laboratory reference ranges may be included if the 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 and 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

          -  Participant must pass the test of understanding (TOU)

          -  Participant must be available and 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

          -  Participant must be between 18 to 50 years of age and must have a documented
             HIV-infection for at least 6 months prior to screening

          -  Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy
             for at least 4 weeks prior to screening and having a CD4 positive cell count of >350
             cells/microliter. 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 and 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 or her age as reported by the parent(s)/legal guardian, according to local routine
             vaccination schedules

        Exclusion criteria:

          -  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