RT Journal Article
SR Electronic
T1 Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial
JF Canadian Medical Association Journal
JO CMAJ
FD Canadian Medical Association
SP E819
OP E827
DO 10.1503/cmaj.170074
VO 189
IS 24
A1 May S. ElSherif
A1 Catherine Brown
A1 Donna MacKinnon-Cameron
A1 Li Li
A1 Trina Racine
A1 Judie Alimonti
A1 Thomas L. Rudge
A1 Carol Sabourin
A1 Peter Silvera
A1 Jay W. Hooper
A1 Steven A. Kwilas
A1 Nicole Kilgore
A1 Christopher Badorrek
A1 W. Jay Ramsey
A1 D. Gray Heppner
A1 Tracy Kemp
A1 Thomas P. Monath
A1 Teresa Nowak
A1 Shelly A. McNeil
A1 Joanne M. Langley
A1 Scott A. Halperin
A1 ,
YR 2017
UL http://www.cmaj.ca/content/189/24/E819.abstract
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