NIH Begins Early Human Clinical Trial of VSV Ebola Vaccine

Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health’s Clinical Center in Bethesda, Maryland.

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are conducting the early phase trial to evaluate the vaccine, called VSV-ZEBOV, for safety and its ability to generate an immune system response in healthy adults who are given two intramuscular doses, called a prime-boost strategy. The Walter Reed Army Institute of Research (WRAIR) is simultaneously testing the vaccine candidate as a single dose at its Clinical Trials Center in Silver Spring, Maryland.

“The need for a vaccine to protect against Ebola infection is urgent,” said NIAID Director Anthony S. Fauci, MD. “NIH welcomes the opportunity to collaborate with the US Department of Defense to conduct human clinical tests of another promising — and hopefully, successful — Ebola vaccine candidate.”

NIAID researchers include principal investigator Richard T. Davey and co-investigator John Beigel of NIAID’s Division of Intramural Research. Early human testing of another investigational Ebola vaccine co-developed by NIAID and GlaxoSmithKline (GSK) began in early September. Initial data on safety and immunogenicity (the capacity to generate an immune response) from clinical trials of the NIAID/GSK Ebola vaccine are expected by the end of 2014.

The VSV-ZEBOV vaccine candidate was developed by researchers at the Public Health Agency of Canada’s National Microbiology Laboratory. It has been licensed to NewLink Genetics Corp through its wholly owned subsidiary BioProtection Systems, both based in Ames, Iowa.

“Canada has long been a world leader in Ebola research and innovation. Scientists at Canada's National Microbiology Lab developed this Ebola vaccine, following years of hard work. We hope the clinical trial at the National Institutes of Health proves to be safe and effective, so that the Canadian Ebola vaccine can be used as a global resource to help save lives and end this complex outbreak in West Africa," said Canada’s Minister of Health Rona Ambrose.

“We are pleased to recognise the extraordinary work of our partners to move the VSV-ZEBOV vaccine candidate from preclinical development to clinical testing in a matter of weeks rather than years. This level of support has been and will continue to be a critical asset in the ongoing process of evaluating and potentially bringing this investigational product to broader use in the fight against Ebola virus,” said Charles Link, Chief Scientific Officer and CEO, NewLink Genetics.