PT  - JOURNAL ARTICLE
AU  - May S. ElSherif
AU  - Catherine Brown
AU  - Donna MacKinnon-Cameron
AU  - Li Li
AU  - Trina Racine
AU  - Judie Alimonti
AU  - Thomas L. Rudge
AU  - Carol Sabourin
AU  - Peter Silvera
AU  - Jay W. Hooper
AU  - Steven A. Kwilas
AU  - Nicole Kilgore
AU  - Christopher Badorrek
AU  - W. Jay Ramsey
AU  - D. Gray Heppner
AU  - Tracy Kemp
AU  - Thomas P. Monath
AU  - Teresa Nowak
AU  - Shelly A. McNeil
AU  - Joanne M. Langley
AU  - Scott A. Halperin
ED  - ,
TI  - Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial
AID  - 10.1503/cmaj.170074
DP  - 2017 Jun 19
TA  - Canadian Medical Association Journal
PG  - E819--E827
VI  - 189
IP  - 24
4099  - http://www.cmaj.ca/content/189/24/E819.short
4100  - http://www.cmaj.ca/content/189/24/E819.full
SO  - CMAJ2017 Jun 19; 189
AB  - BACKGROUND: The 2013–2016 Ebola virus outbreak in West Africa was the most widespread in history. In response, alive attenuated recombinant vesicular stomatitis virus (rVSV) vaccine expressing Zaire Ebolavirus glycoprotein (rVSVΔG-ZEBOV-GP) was evaluated in humans.METHODS: In a phase 1, randomized, dose-ranging, observer-blind, placebo-controlled trial, healthy adults aged 18–65 years were randomized into 4 groups of 10 to receive one of 3 vaccine doses or placebo. Follow-up visits spanned 180 days postvaccination for safety monitoring, immunogenicity testing and any rVSV virus shedding.RESULTS: Forty participants were injected with rVSVΔG-ZEBOV-GP vaccine (n = 30) or saline placebo (n = 10). No serious adverse events related to the vaccine or participant withdrawals were reported. Solicited adverse events during the 14-day follow-up period were mild to moderate and self-limited, with the exception of injection-site pain and headache. Viremia following vaccination was transient and no longer detectable after study day 3, with no virus shedding in saliva or urine. All vaccinated participants developed serum immunoglobulin G (IgG), as measured by Ebola virus envelope glycoprotein-based enzyme-linked immunosorbent assay (ELISA). Immunogenicity was comparable across all dose groups, and sustained IgG titers were detectable through to the last visit, at study day 180.INTERPRETATION: In this phase 1 study, there were no safety concerns after a single dose of rVSVΔG-ZEBOV-GP vaccine. IgG ELISA showed persistent high titers at 180 days postimmunization. There was a period of reactogenicity, but in general, the vaccine was well tolerated. This study provides evidence of the safety and immunogenicity of rVSVΔG-ZEBOV-GP vaccine and importance of its further investigation. Trial registration: Clinical-Trials.gov no., NCT02374385