CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne

Safety and immune response of a new Ebola vaccine in healthy adults: a randomized trial

Updated

Abstract

Forty participants received the rVSVΔG-ZEBOV-GP vaccine with no serious adverse events reported.

  • No serious adverse events related to the vaccine were observed during the study.
  • Most adverse events reported were mild to moderate and self-limited, primarily involving injection-site pain and headache.
  • Viremia following vaccination was transient, with no detectable virus after study day 3.
  • No virus shedding was found in saliva or urine among participants.
  • All vaccinated participants developed serum immunoglobulin G (IgG) against the Ebola virus.
  • Sustained high titers of IgG were detectable up to 180 days post-immunization.

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Funding

Competing interests

Competing interests: May ElSherif reports grants from the Canadian Institutes of Health Research/Public Health Agency of Canada, during the conduct of the study. Donna MacKinnon-Cameron reports an operating grant from the Canadian Institutes of Health Research/Public Health Agency of Canada, during the conduct of the study. Li Li reports an operating grant from the Canadian Institutes of Health Research/Public Health Agency of Canada, during the conduct of the study. Judie Alimonti reports personal fees from NewLink Genetics, outside the submitted work; and Her Majesty the Queen in right of Canada holds a patent related to the rVSVΔG-ZEBOV-GP vaccine (patents: EU 1 527 087; US 8 012 489; CA 2,493,142). W. Jay Ramsey was an employee of NewLink Genetics during the conduct of the study, and reports personal fees as a salaried employee of NewLink Genetics, outside the submitted work. Donald Gray Heppner reports grants from the Department of Health and Human Services, during the conduct of the study and employment by NewLink Genetics Inc. (which is developing the vaccine described in this article), outside the submitted work. Tracy Kemp was an employee of NewLink Genetics during the conduct of the study; she also reports personal fees as a salaried employee of NewLink Genetics, outside the submitted work. Thomas Monath reports a grant from BARDA and the US Department of Health and Human Services, and financial support for study, personal salary and benefits from New-Link Genetics. Shelly McNeil reports an operating grant from the Canadian Institutes of Health Research/Public Health Agency of Canada, during the conduct of the study; and grants and personal fees from vaccine manufacturers (such as Merck, GlaxoSmithKline Biologicals, Sanofi Pasteur and Pfizer) outside the submitted work. Joanne Langley reports an operating grant from the Canadian Institutes of Health Research/Public Health Agency of Canada, during the conduct of the study, as well as grants and personal fees from vaccine manufacturers (such as Merck, Glaxo-SmithKline Biologicals, Sanofi Pasteur, Pfizer, and Novartis) to conduct vaccine clinical trials, outside the submitted work. Scott Halperin reports an operating grant from the Canadian Institutes of Health Research/Public Health Agency of Canada, during the conduct of the study, and grants and personal fees from vaccine manufacturers (such as Merck, GlaxoSmithKline Biologicals, Sanofi Pasteur, Pfizer and Novartis) outside the submitted work. No other competing interests were declared.
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