Human trials of Canada’s experimental Ebola vaccine are expected to start in the United States this fall, but, like other vaccine candidates headed for accelerated testing in humans, the Canadian-developed injection will not be deployed to the West African outbreak until next year at the earliest.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced Thursday that it would begin next week enrolling healthy adult volunteers in a phase I trial of a different vaccine, developed in partnership with the pharmaceutical giant GlaxoSmithKline, Inc., and based on a chimpanzee cold virus.
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The experimental vaccines could still prove useful in the current West African crisis, which shows no signs of abating.
In a bleak assessment of the future path of the outbreak, the World Health Organization warned Thursday that it could spread to as many as 20,000 people in the region and take as long as nine months to quell.
Human trials of the Canadian vaccine are expected to follow in the fall at the Walter Weed Army Institue of Research in Silver Spring Maryland, according to NIAID, which is collaborating with the U.S. Department of Defense and an Iowa drug maker on testing the Canadian-developed vaccine in humans.
“I think front of the line is pretty much where they [the Canadian vaccines] are right now,” Anthony Fauci, director of NIAID, said. “This is a trial that’s gonna start as soon as the regulatory and other aspects of it are determined.”
Dr. Fauci predicted it would take until the end of this year to collect enough data from the phase I trials – which are designed to ensure the experimental vaccines are safe and provoke an immune response in healthy volunteers – to determine if the products are ready to be sent to the front lines of the crisis.
“When you’re dealing with normal human beings who are the recipients of the vaccine, safety is paramount,” Dr. Fauci said. “It’s absolutely paramount.”
The United Nations health agency issued a strategic plan to combat the outbreak in four West African nations where it said the actual number of cases could already be two to four times higher than the reported 3,069. The official death toll stands at 1,552.
Ottawa announced on Aug. 11 that it would donate as many as 1,000 doses of an experimental vaccine partly developed by scientists at the Public Health Agency of Canada’s National Microbiology Lab in Winnipeg to the WHO for use in West Africa.
Since then, PHAC has said little publicly about plans for the vaccine, known as VSV-EBOV, about 1,500 doses of which were at the time sitting in storage at the Winnipeg lab.
In a teleconference with reporters Thursday, NIAID provided the first details on how human trials would proceed, including testing of the Canadian vaccine.
In the case of the NIAID/GSK vaccine – the first scheduled to begin trials – the testing will begin with 20 healthy adult volunteers, half of whom will receive an intramuscular injection of the regular-strength vaccine. The rest will receive the same vaccine at a higher dose.
The NIAID has also arranged to test the vaccine on 60 healthy volunteers in England, 40 in Mali and 40 in Gambia.
Dr. Fauci said Sierra Leone, Liberia and Guinea, the countries hit hardest by the current Ebola crisis, do not have the health infrastructure in place to host a proper clinical trial, especially right now.
Dr. Fauci said he expected the phase I trial for the Canadian vaccine to roll out in a similar fashion.
“The development plans for that vaccine is really in the hands of the Public Health Agency of Canada,” he said.
“As far as the development plan, the phase I trial will proceed a little bit later than we’re starting but not too much later and then we’ll all look to the safety and immunogenicity data to determine where one goes in the development of that as a potentially licencable product.”
With a report from Reuters