Canadian-made Ebola vaccine starting clinical trials in humans

Health Minister Rona Ambrose said trials are moving at “unprecedented speeds,” but critics slam government for not acting faster amid deadly outbreak.Clinical trials are now starting for an experimental made-in-Canada Ebola vaccine amid growing global concern over the disease that’s left more than 4,000 people dead.Federal Health Minister Rona Ambrose called the trials “promising news” in the fight against the largest-ever Ebola outbreak. As part of a process Ambrose said is moving at “unprecedented speeds,” results of the first phase are expected in December, and the hope is the vaccine can be deployed shortly thereafter.At this time, however, it’s unclear if the vaccine will ever reach people on the ground in West Africa — and critics say the trials didn’t happen nearly fast enough.

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“This is a shameful delay,” said Amir Attaran, a University of Ottawa professor and Canada Research Chair in law, population health, and global development policy. “The competing vaccine is way ahead of where we are, and that worries me,” he added. That second experimental vaccine is being produced by pharmaceutical giant GlaxoSmithKline alongside the U.S. National Institute of Allergy and Infectious Diseases, and human trials have already started in Africa. The Canadian vaccine — which many scientists consider the more promising of the two — was developed by researchers at the Public Health Agency of Canada’s National Microbiology Laboratory. Ambrose said it has been “100-per-cent effective” in preventing the spread of the Ebola virus when tested on animals. The Canadian government owns the intellectual property associated with the vaccine and has licensed the rights to a small American company, NewLink Genetics, through its subsidiary BioProtection Systems. The first phase of human clinical trials will be conducted in a lab in Silver Spring, Md., and will test the vaccine on a small group of healthy people to assess its safety, help determine proper dosage levels and identify any side-effects. “We currently have the two vaccines that are being tested and this has created sort of a ‘space race’ to find out which vaccine is going to be the first to the finish line,” noted Toronto-based microbiologist Jason Tetro. “If one of the two vaccines is slow in advancing to trials, you’ve taken a two-horse race and you’ve made it a one-horse race,” added Attaran. He said researchers need to generate data on both vaccines as soon as possible to know which one works best — or works at all. Tetro said he appreciates the need for proper protocols when it comes to clinical trials, but he would have liked to see them happen faster.

“The fact is that we really started to be concerned about this probably four months after we should have,” he said. “And it really wasn’t until somebody … appeared on North American soil with the Ebola virus that it really took off.” By the time it became clear that a vaccine would likely be needed, it was too late to prevent the high numbers of cases and deaths, he said. There have been at least 8,400 cases of Ebola, according to the latest available numbers from the Centers for Disease Control and Prevention. Toronto emergency department physician Dr. Brett Belchetz said the Canadian vaccine’s clinical trials have been greatly accelerated when compared to typical clinical trials that may take months or even years. But he said people shouldn’t be overly hopeful about the vaccine’s potential.

“Right now, all we have are animal trials that were successful,” he said, adding there are hundreds of examples in medical literature of drugs and vaccines that were successful in animals but didn’t work for humans. But Ambrose said if this Ebola vaccine is shown to be safe and effective, “it will stop this devastating outbreak.”

“This is an excellent step towards not only putting an end to the current Ebola epidemic, but also possibly preventing all future epidemics,” noted Tetro. Dr. Gregory Taylor, Canada’s chief public health officer, stressed that no one will be at risk of contracting Ebola during this first phase of clinical trials. “The vaccine does not contain any live Ebola virus,” he said.Around 40 volunteers will be taking the vaccine and will be monitored by public health professionals for any side-effects, he said. They will also be assessed to see how well their immune systems are producing antibodies against Ebola.Taylor explained that when a person takes a vaccine, “it prompts their immune system to start making antibodies” to find and neutralize foreign objects such as viruses.

Monday’s announcement of the Canadian vaccine trials came as two patients at separate Ontario hospitals awaited Ebola test results while in isolation. One patient at Ottawa Hospital’s General Campus was “under investigation” Monday after displaying Ebola-like symptoms, but tests came out negative. That patient recently visited a West African country, according to a city of Ottawa press release.Another patient at Belleville General Hospital was also being tested for the virus. Quinte Health Care spokesperson Susan Rowe stressed that it’s “highly unlikely” the patient, who recently entered Sierra Leone, is actually carrying the virus.Health Canada said there have been no confirmed cases of Ebola in Canada.

But south of the border, a Texas health-care worker tested positive for the virus after caring for an Ebola patient who later died; in Spain, a nursing aide who contracted Ebola remains in hospital.

“I think most of us working in health care are quite afraid at this point,” Belchetz said. Various countries, including Canada, have been ramping up airport screening in major cities in an attempt to detect passengers carrying Ebola.Not all are in favour of this practice. “Airport screening is essentially useless,” said Belchetz, adding passengers could fly before knowing that they’re sick.But Tetro applauded the screening initiative. “Does that mean they’re going to find anyone? No … but it shows that the system is there,” he said.

Tetro said that screening creates a chain of communication and a record of the person’s interaction at the airport, which could prove useful if they later show up at a health-care facility with Ebola symptoms.Alongside domestic protection measures, Ambrose noted the Canadian government has committed more than $35 million in various forms of overseas Ebola aid, including a shipment of personal protective equipment last week. This shipment has now arrived in West Africa.