A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
Condition: Ebola Viral Disease
MeSH terms: Hemorrhagic Fever, Ebola; Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3
      vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as
      2-dose heterologous regimens.
    

Detailed description: 
      This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase
      2 study evaluating the safety, tolerability and immunogenicity of 2-dose heterologous
      regimens using Ad26.ZEBOV and MVA-BN-Filo administered to healthy adults participants in
      Europe. The study involves a screening period of up to 12 weeks, a vaccination period in
      which participants will be vaccinated with Ad26.ZEBOV (dose 1) followed by vaccination with
      MVA-BN-Filo (dose 2) 28, 56 or 84 days later, and a post-vaccination phase until 6 months
      post dose 2 visit (Days 209, 237 or 265). After unblinding, only participants who received
      Ad26.ZEBOV and/or MVA-BN-Filo will continue the study until the Day 365 visit (or until the
      start of the roll-over study or for an additional 12 months [whichever comes first] for
      participants in France who agree to continue the long-term follow-up after Day 365) to assess
      long-term safety and immunogenicity. Participants will enroll into 3 cohorts: that is, Cohort
      1 (Participants will receive Ad26.ZEBOV and MVA-BN-Filo in an open-label fashion), Cohort 2
      (Participants will be randomized to receive the 2-dose heterologous vaccine regimen with
      either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 14:1 ratio) and Cohort 3
      (Participants will be randomized to receive the 2-dose heterologous vaccine regimen with
      either Ad26.ZEBOV followed by MVA-BN-Filo, or placebo in a 10:3 ratio). In Cohorts 2 and 3,
      core immunogenicity assessments (humoral and cellular assays) will be performed. In Cohort 2,
      additional immunogenicity assessments will be done. In Cohort 1, plasma blast response
      kinetics will be evaluated. Safety will be monitored during the study.
    

Intervention name(s): MVA-BN-Filo; Ad26.ZEBOV; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.; One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.; One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
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: Treatment
Keywords: Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Safety; Immunogenicity; Inserm and University of Oxford