VSV-ZEBOV Geneva Vaccine Trial
Condition: Ebolavirus Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola
      outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven
      therapy or prevention available at this time.

      The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in
      preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in
      large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials
      are needed. To accelerate this process, the World Health Organization (WHO) has constituted a
      consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use
      similar protocols to collectively include roughly 250 volunteers, the sample size required to
      identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2
      different doses of BPSC1001.

      The joint primary objectives of this single-center, double-blind, randomized
      placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of
      the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine
      dose and to define whether seroresponses differ significantly following immunization with the
      lower or higher vaccine dose.
    

Detailed description: 
      This single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study
      will have two randomization schemes. Volunteers who could later be exposed to Ebolavirus
      while working in epidemic areas ("deployable subjects") will be randomized to receive one of
      two vaccine doses. Non-deployable volunteers, with no identified risk of Ebola exposure in
      the near term, will be allocated to one of three groups and receive the lower or higher
      vaccine dose, or a placebo. A single immunization will be performed. All subjects will be
      observed in the clinical trials unit (CTU) for 1.5 hours after vaccine/placebo injection.
      Subjects will complete post-injection diaries for 7 days after injection, as well as
      post-injection follow-up visits (see below). On-site visits at the CTU will occur on days -90
      to -1, 0, 1, 3, 7, 14, 28, 84, 168. Some subjects with a positive serologic response at 24
      weeks may be requested to return for immune durability testing at 12 months.

      One or more interim analyses will be undertaken to guide decisions on 1) the potential use of
      the vaccine in Ph2/3 trials in affected countries and 2) potential modification of the
      trial(s) through an amendment to evaluate a higher dose, if immunogenicity is poor, or a
      lower dose if the dosage levels selected are not safe and reasonably well tolerated.
    

Intervention name(s): VSV-ZEBOV
Intervention type(s): Biological
Intervention description(s): See arm/group descriptions.
Other intervention name(s): BPSC1001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ebolavirus Vaccines