Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study
The Lancet Infectious Diseases·
- DOI
- 10.1016/s1473-3099(17)30313-4
- PMID
- 28606591
- PMCID
- —
- OpenAlex
- W2624564619
- Study type
- Randomised controlled trial
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Findings informed dose selection for subsequent phase 3 evaluation of the rVSV∆G-ZEBOV-GP candidate, contributing evidence toward a deployable Ebola virus vaccine following the 2014 Zaire Ebola virus outbreak.
Structured evidence summary
Research question
The study evaluated the safety, reactogenicity, and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola vaccine candidate across a wide dose range in healthy adults.
Study design
A phase 1b, randomised, multicentre, double-blind, placebo-controlled, dose-response trial conducted in two sequential cohorts across eight US sites, with primary safety assessed over 14 days and arthritis/dermatitis surveillance through day 56.
Population and setting
Healthy adults aged 18–61 years enrolled between December 2014 and June 2015 at eight US study sites, with 513 participants randomised across dose groups and placebo.
Main findings
Adverse events were mostly mild-to-moderate, of short duration, and more frequent at doses of 9 × 10⁶ PFU or higher. At the 2 × 10⁷ PFU dose selected for phase 3 trials, common local and systemic reactions (e.g., arm pain, headache, fatigue, myalgia, subjective fever) were more frequent than with placebo, and self-limited arthritis and dermatitis occurred in a small proportion of vaccinees. Antibody responses were detectable by day 14, dose-related, robust at 2 × 10⁷ PFU (seroconversion ~95.7% for both IgG ELISA and PRNT60), and sustained through one year.
Public-health relevance
Findings informed dose selection for subsequent phase 3 evaluation of the rVSV∆G-ZEBOV-GP candidate, contributing evidence toward a deployable Ebola virus vaccine following the 2014 Zaire Ebola virus outbreak.
Important limitations
The summary is limited to the supplied single-article abstract and metadata; the original publication is required for decision-grade interpretation, including detailed statistical analyses, full adverse event profiles, and any author-noted limitations.
GIDS interpretation
The article is catalogued under outbreak investigation, surveillance, and vaccination topics for Ebola, providing contextual background literature; this summary does not link the paper to any active surveillance signal.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 14 auditable classifier relationships to diseases, places, topics, and study design.