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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase
      2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost
      regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-,
      56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly
      participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in
      HIV-infected participants and in healthy children in 2 age strata. The study consists of a
      screening phase of up to 8 weeks, a vaccination phase in which participants will be
      vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a
      post-vaccination phase and long-term follow-up phase until Day 365. Participants in Cohort 1
      substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will
      receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as
      third vaccination (at least 1 year post prime vaccination). All participants within a cohort
      will be followed in a blinded manner by the site until the last subject in that cohort has
      completed the study. This study will be conducted in Africa and the enrollment will take
      place sequentially in three cohorts: the first cohort will consist of healthy participants
      (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50
      years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include
      children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will
      be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations
      will include assessments of adverse events, an electrocardiogram (ECG) for adult participants
      at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body
      temperature), clinical laboratory and pregnancy testing. An independent data monitoring
      committee (IDMC) will be established to monitor data on a regular basis to ensure the
      continuing safety of the participants enrolled in the study.
    

Intervention name(s): Ad26.ZEBOV; MVA-BN-Filo; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
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