(Source: The Wall Street Journal 2014-10-13）
Canada said Monday it is launching clinical human trials for its experimental Ebola vaccine, with initial results expected as early as December, as it moves at an “unprecedented speed” to deploy the serum amid warnings from the World Health Organization that the outbreak is the most acute medical crisis in modern times.
The trial will be conducted at Maryland’s Walter Reed Army Institute of Research, with an eye toward determining its safety, the appropriate dosage required to produce antibodies, and possible side effects. Canada has supplied 20 vials of the vaccine, also known as VSV-EBOV, for the trial.
Canadian health officials said they hope to get initial results from the human trials in mid-to-late December. Planning is already under way for the next stage of trials, to be conducted in Africa.
Medical officials said the vaccine should prompt the immune system to produce antibodies, which then identify and neutralize foreign objects, such as bacteria and viruses.
Canadian Health Minister Rona Ambrose said should the vaccine prove as effective in humans as tests have shown in animals, then “we could literally stop this outbreak.” The hope is the vaccine can be deployed shortly after test results come back, she added.
“This process is moving at an unprecedented speed,” said Ms. Ambrose at a news conference in Toronto. “The global community has come together to move the Canadian vaccine forward.”
This is the latest test of an Ebola-fighting virus on humans, as the U.S. National Institutes of Health said in August it would begin a clinical trial involving a vaccine co-developed by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases.
The Food and Drug Administration authorized Canada’s Tekmira Pharmaceuticals Corp. to provide an experimental drug to people with confirmed or suspected Ebola virus infections.
The Canadian government owns the intellectual property rights associated with the vaccine, which has been developed at its main microbiology laboratory in Winnipeg, Manitoba. The vaccine’s licensing rights belong to NewLink Genetics Corp.NLNK +23.66% , of Austin, Texas.
Charles Link, chief executive of NewLink, said he has never seen anything in his career like the pace at which the Canadian vaccine has moved to the testing stage. Moving to a clinical trial stage generally takes one to two years, based on approvals required from medical authorities. In this case, Dr. Link said, it took roughly eight weeks, as authorities took into account the Ebola outbreak, which originated in west Africa and according to the WHO has claimed over 4,000 lives.
“People have been working nights and weekends since the Ebola crisis exploded,” said Dr. Link. “And as the crisis accelerated, everybody just lined up and started working.”
Canadian authorities added other clinical trials are being considered for Canada, Africa and Europe, once data are available from the initial tests at the Walter Reed institute. There was no timeline provided as to when the vaccine might receive final approval from the FDA. Generally, vaccines go through three phases of testing, with the second and third stages focused on testing the serum on larger group of patients. Dr. Link said there is work under way on the Canadian vaccine to combine the second and third phases into one stage.
Canada had pledged to donate between 800 and 1,000 doses of the vaccine to the WHO for use in Africa. The delivery has yet to unfold, and Ms. Ambrose said public-health officials and WHO were in talks to iron out “ethical and logistical” challenges with the aim of a resolution in the near future.
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