A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)
Condition: Ebola Disease; Immunisation
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      This initial, proof of concept study will focus on identifying significant differences in
      response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo,
      MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the
      ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of
      booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and
      efficacy measures. There is no formal hypothesis for this study. The primary objective of
      this study is to assess the safety and reactogenicity of study products by study group when
      administered IM to healthy adults.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind trial of 60 evaluable males and non-pregnant
      females, 18-45 years old, inclusive, who are in good health, meet all eligibility criteria,
      and do not meet any exclusion criteria. This trial is designed to assess the safety,
      reactogenicity and immunogenicity of an Ebolavirus Zaire (ChAd3-EBO-Z) vaccine for the
      prevention of Ebola. ChAd3-EBO-Z will be administered intramuscularly into the deltoid of all
      participants on Day 1. On Day 8, subjects will receive either placebo, ChAd3-EBO-Z , or MVA-
      BN(R)-Filo boosters, administered intramuscularly into the deltoid of the arm opposite their
      first vaccination, based on study group. There will be 20 subjects in each group. Subjects
      will be monitored for 6 months after vaccination to assess safety and efficacy for
      ChA3d-EBO-Z with homologous and heterologous boosting. Differences between the homologous and
      heterologous arm represent potential points for further, more in depth assessment to
      determine if there is a correlation with efficacy. Long term goals include comparing results
      from this study with results from naturally infected individuals as well as non-human primate
      (NHP) vaccination/challenge studies. There is no formal hypothesis for this study. The
      primary objective of this study is to assess the safety and reactogenicity of study products
      by study group when administered IM to healthy adults. The secondary study objective is to
      assess the antibody response to Zaire ebolavirus (EBOV) glycoprotein (GP) by study group.
    

Intervention name(s): ChAd3-EBO-Z; MVA Multi-Filo Ebola Vaccine; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)).; A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10^8 Infectious Units (IU).; 0.5 mL normal saline administered via IM injection into the deltoid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adenovirus vector; Ebola Virus; Immunogenicity; Non-Human Primates Vaccination/Challenge Studies; Phase 1; Reactogenicity; Safety; Zaire ebolavirus vaccine