Canadian-made Ebola vaccine to start trials in healthy humans

Twenty vials of the vaccine have been sent to a research institute in Maryland for testing on about 40 healthy volunteers

TORONTO – Human testing of an experimental Canadian-made Ebola vaccine began Monday, with federal officials saying the drug could be shipped to West Africa within months if it proves successful.

Health Minister Rona Ambrose said the launch of the vaccine’s first clinical trial marks a promising step in the global campaign to contain the virus, which the World Health Organization says has killed more than 4,000 people.

“This provides hope because if the Canadian vaccine is shown to be safe and effective, it will stop this devastating outbreak,” Ambrose said in a conference call from Calgary.

Twenty vials of the vaccine have been sent to the Walter Reed Army Institute of Research in Maryland for testing on about 40 healthy volunteers, she said.

The Phase 1 trial will determine if the vaccine created by Public Health Agency of Canada and known as VSV-EBOV is safe for human use. It will also determine the proper dosage level and test for possible side effects, Ambrose said.

Studies have shown the vaccine works in primates both to prevent infection when given before exposure and to increase survival chances when given quickly after exposure.

Canada’s chief public health officer said results from the human trial are expected by December, and if successful, the next stage would be to test it in a larger human sample, including those directly handling Ebola cases in West Africa.

“The health-care workers on the ground are the most likely target to do the next step,” which could begin by the end of the year or early 2015, Dr. Gregory Taylor said in a news conference in Toronto.

“Clearly if those studies show that it’s effective in health-care workers, the world would go into mass production.”

A small U.S. company called NewLink Genetics holds the licence for the vaccine and will be arranging the trials at the U.S. military lab.

NewLink said earlier this month that at least five clinical trials involving the vaccine would soon be underway in the United States, Germany, Switzerland and in an unnamed African country which is not battling Ebola. The Canadian government has also said it wants to conduct a trial in this country.

The aim of these early trials is to see if the vaccine is safe for human use and how much vaccine is needed to generate what is hoped to be a protective response in people.

Another leading Ebola vaccine candidate, created in the laboratories of the U.S. National Institutes of Allergy and Infectious Diseases, has been licensed to pharma giant GlaxoSmithKline (now known as GSK). The first clinical trial with that vaccine, called cAd3, began in early September.

There have been no reported Canadian cases and health officials maintain the risk of Ebola emerging remains very low.

It was a message that officials in two Ontario cities stressed again on Monday as they announced that two patients – one in Ottawa, the other in Belleville – were placed in isolation as a precaution because they showed Ebola like symptoms.

Later Monday, Ottawa public health tweeted that Ebola had been ruled out in the case it was watching.

The patient in Belleville was in Sierra Leone recently but doctors considered it unlikely the symptoms would turn out to be Ebola, said Dr. Richard Schabas, the medical health officer responsible for Belleville.

”You’re going to see many instances like this over the next few weeks as health care workers and others return from the area (West Africa),” Schabas told a news conference in the eastern Ontario city.

”We’re going to become very used to it.”

Preliminary test results in both cases were expected later Monday or Tuesday.

Stricter screening measures, including the posting of quarantine officers at airports in Toronto and Montreal, are nonetheless being implemented after the first case of human-to-human transmission in the United States, Ambrose said.

One man died from Ebola in Texas after contracting it in Liberia, and it was announced Sunday that a nurse at the man’s hospital has also become infected with the virus despite wearing protective equipment.

While there are no direct flights to Canada from West Africa, about 30 people a week arrive on connecting flights from Guinea, Sierra Leone and Liberia _ the three African countries devastated by Ebola, Ambrose said.

“We’re not talking about a great deal of people. We’re also talking about a situation where Canadian border service agents are alerted, or should be alerted, about whether travellers are originating in any of the affected countries.”

Ottawa is urging the 216 Canadians known to be living in Guinea, Sierra Leone and Liberia to come home immediately, but Ambrose said a travel ban is not currently being considered.

Taylor said he would be meeting with provincial and territorial public health officials on Tuesday to review existing guidelines on how frontline health workers would handle an Ebola patient.

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