Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe.

ABSTRACT:

Background

The replication-competent recombinant vesicular stomatitis virus (rVSV)-based vaccine expressing a Zaire ebolavirus (ZEBOV) glycoprotein was selected for rapid safety and immunogenicity testing before its use in West Africa.

Methods

We performed three open-label, dose-escalation phase 1 trials and one randomized, double-blind, controlled phase 1 trial to assess the safety, side-effect profile, and immunogenicity of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and Africa. All participants were injected with doses of vaccine ranging from 300,000 to 50 million plaque-forming units (PFU) or placebo.

Results

No serious vaccine-related adverse events were reported. Mild-to-moderate early-onset reactogenicity was frequent but transient (median, 1 da

SUBMITTER: Agnandji ST 

PROVIDER: S-EPMC5490784 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature