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 ElSherif, May S.
A1 Brown, Catherine
A1 MacKinnon-Cameron, Donna
A1 Li, Li
A1 Racine, Trina
A1 Alimonti, Judie
A1 Rudge, Thomas L.
A1 Sabourin, Carol
A1 Silvera, Peter
A1 Hooper, Jay W.
A1 Kwilas, Steven A.
A1 Kilgore, Nicole
A1 Badorrek, Christopher
A1 Ramsey, W. Jay
A1 Heppner, D. Gray
A1 Kemp, Tracy
A1 Monath, Thomas P.
A1 Nowak, Teresa
A1 McNeil, Shelly A.
A1 Langley, Joanne M.
A1 Halperin, Scott A.
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