• May S ElSherif, Catherine Brown, Donna MacKinnon-Cameron, Li Li, Trina Racine, Judie Alimonti, Thomas L Rudge, Carol Sabourin, Peter Silvera, Jay W Hooper, Steven A Kwilas, Nicole Kilgore, Christopher Badorrek, W Jay Ramsey, D Gray Heppner, Tracy Kemp, Thomas P Monath, Teresa Nowak, Shelly A McNeil, Joanne M Langley, Scott A Halperin, and Canadian Immunization Research Network.
• Canadian Center for Vaccinology (ElSherif, Brown, MacKinnon-Cameron, Li, McNeil, Langley, Halperin), IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS; National Microbiology Laboratory (Racine, Alimonti), Winnipeg, Man.; Battelle Biomedical Research Center (Rudge, Sabourin), Columbus, Ohio; United States Army Medical Research Institute of Infectious Disease (Silvera, Hooper, Kwilas), Fort Detrick, Md.; Joint Program Executive Office for Chemical and Biological Defense Medical Countermeasure Systems' Joint Vaccine Acquisition Program (Kilgore, Badorrek), Fort Detrick, Md.; BioProtection Systems/NewLink Genetics Corporation (Ramsey, Heppner, Kemp, Monath), Ames, Iowa; Veristat LLC (Nowak), Southborough, Mass.
• CMAJ. 2017 Jun 19; 189 (24): E819-E827.

BackgroundThe 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.MethodsIn 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.ResultsForty 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.InterpretationIn 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.© 2017 Canadian Medical Association or its licensors.

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