The candidate is being developed by Merck & Co. and NewLink Genetics with support from the Public Health Agency of Canada, National Institutes of Health, US Department of Defence, and BARDA (Biomedical Advanced Research and Development Authority).
rVSV-ZEBOV is a recombinant vector vaccine based on the vesicular stomatitis virus (VSV). It expresses glycoproteins of the Zaire Ebola strain.
A second vaccine will be tested in a sequential study, as soon as supply becomes available.
The trial will be run by WHO, Health Ministry of Guinea, Médecins Sans Frontières (MSF), Epicentre, and The Norwegian Institute of Public Health (NIPH), following promising data from early clinical trials late last year.
“We have worked hard to reach this point,” said WHO Director-General, Dr Margaret Chan. “There has been massive mobilization on the part of the affected countries and all partners to accelerate the development and availability of proven interventions. If a vaccine is found effective, it will be the first preventive tool against Ebola in history.”
The trial will vaccinate members of the public in Basse Guinée, the region of Guinea most struck by Ebola. Using “ring vaccination” strategy developed to eradicate smallpox in the 1970s, scientists will identify newly diagnosed Ebola patients – the “index case” – and offer vaccination to everyone they have come into contact with. Frontline workers in the area will also be enrolled.
The trial will assess whether the vaccine protects contacts of the “index case” and also whether creating a ring or buffer of protected individuals will halt spread of the infection.
“The Ebola epidemic shows signs of receding but we cannot let down our guard until we reach zero cases,” said WHO Assistant Director-General Marie-Paule Kieny. “An effective vaccine to control current flare-ups could be the game-changer to finally end this epidemic and an insurance policy for any future ones.”
“Participation of the community in the study areas in Guinea is vital to enable the successful assessment of this vaccine,” said John-Arne Røttingen, NIPH, and Chair of the study steering group. “The study process has ensured the inclusion of Guinean investigators since its inception, and is a response to a request from Guinean authorities.”
The Guinea National Regulatory Authority has reviewed the trial protocol with support from Health Canada.
GSK’s cAd3-ZEBOV vaccine, which it developed with NIH, is also showing promise. Click here for BioPharma-Reporter.com’s infographic round-up of the pharmaceutical industry’s progress producing an Ebola vaccine.