Ebola outbreak: 1st human trials of Canadian vaccine start in U.S.

The first human clinical trials of a Canadian-developed Ebola vaccine, VSV-EBOV, begin in Maryland today to assess the vaccine's safety and determine the appropriate dosage to fight the virus that has killed more than 4,000 people, largely in West Africa, Health Minister Rona Ambrose has announced.

"We are able to share some very promising and hopeful news in the fight against Ebola," Ambrose said from Calgary. 

She made the announcement at a joint news conference with chief public health officer Dr. Gregory Taylor, who spoke from Toronto.

Both stressed no individuals in Canada have ever been diagnosed with Ebola, and the risk of contracting the disease remains low in this country. One person in Belleville, Ont., is in isolation with Ebola-like symptoms, though the hospital described the case as "extremely low risk." Another person who had been in isolation in Ottawa since Sunday tested negative for the virus on Monday, health officials said.

• Ebola-like symptoms seen in 2 cases in Ottawa, Belleville
• Ebola outbreak: More cases possible among those who cared for Dallas patient
• Ebola outbreak: Here's what you need to know
• Ebola screenings planned at 6 Canadian airports

The vaccine, which was developed by scientists at the Public Health Agency of Canada's National Microbiology Laboratory in Winnipeg, will be tested on 20 healthy volunteers at the Walter Reed Army Institute of Research in Silver Spring, Md.

Studies in primates have shown the vaccine prevents infections, if given before exposure, and increases survival chances among those who get it quickly after exposure.

The results from the Phase 1 human trials will be completed by December, Ambrose said, although no specific date was given.

She said the vaccine has been shown to be "100 per cent effective" in preventing the spread of the Ebola virus when tested on animals.

"This provides hope because if the Canadian vaccine is shown to be safe and effective [in humans], it will stop this devastating outbreak," Ambrose said.

The Canadian government owns the intellectual property rights to the vaccine but has licensed the rights to a small U.S. biotech company called NewLink Genetics through its wholly owned subsidiary, BioProtection Systems, the public agency said.

The U.S. Defence Threat Reduction Agency, which is part of the U.S. Defence Department, is working with BioProtection Systems to further develop the product for use in humans.

Canada has supplied 20 vials of the experimental vaccine for use in the trial.

Other Phase 1 clinical trials possible

The public health agency said other Phase 1 clinical trials are being considered for Canada, Europe and Africa.

Taylor said if the results are successful, the next stage would be to test it in a larger human sample, including those
directly handling Ebola cases in West Africa.

Fear of infection has spread around the world much faster than the virus.- WHO director general Margaret Chan

"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, he said.

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

Canada announced in August that it would donate up to 1,000 doses of the vaccine to the World Health Organization as part of its contribution to the international effort to fight the virus, which has mainly affected Liberia, Sierra Leone and Guinea, but the vaccine has yet to be shipped from the Winnipeg lab.

The public health agency blamed the delay on the WHO, but an article in the journal Science suggested a fight over intellectual property rights to the vaccine may be behind the delay. The article, published on the journal's website earlier this month, suggested NewLink Genetics was "worried about losing control over the development of the vaccine."

The doses are expected to finally be shipped later this week, according to Marie-Paule Kieny, WHO assistant director general for health systems and innovation at the WHO.

Ebola 'most severe' modern health emergency 

The WHO on Monday called the Ebola outbreak "the most severe, acute health emergency seen in modern times," and a day after a Texas health-care worker tested positive for Ebola — the first known case of the disease being contracted or transmitted in the U.S.

The preliminary test found the Texas worker was wearing full protective gear while caring for a hospitalized patient who later died from the virus, health officials said Sunday.

Dr. Tom Frieden, head of the Centers for Disease Control and Prevention, said the diagnosis shows there was a clear breach of safety protocol and all those who treated Thomas Eric Duncan are now considered potentially exposed.

"We don't know what occurred in the care of the index patient, the original patient, in Dallas, but at some point there was a breach in protocol, and that breach in protocol resulted in this infection," Frieden told a news conference.

The worker wore a gown, gloves, mask and shield while she cared for Duncan during his second visit to Texas Health Presbyterian Hospital, said Dr. Daniel Varga of Texas Health Resources, which runs the hospital. Frieden said the worker has not been able to identify a specific breach of protocol that might have led to her being infected.

Curbing economic disruptions

Earlier Monday, the WHO also said economic disruptions can be curbed if people are adequately informed to prevent irrational moves to dodge infection from Ebola.

WHO director general Margaret Chan, citing World Bank figures, said 90 per cent of economic costs of any outbreak "come from irrational and disorganized efforts of the public to avoid infection."

"We are seeing, right now, how this virus can disrupt economies and societies around the world," she said, but added that adequately educating the public was a "good defence strategy" and would allow governments to prevent economic disruptions.

The Ebola epidemic has killed more than 4,000 people, mostly in the West African countries of Liberia, Sierra Leone and Guinea, according to WHO figures published last week.

Chan did not specify those steps, but praised the Philippines for holding an anti-Ebola summit last week that was joined by government health officials and private-sector representatives, warning that the Southeast Asian country was vulnerable due to the large number of Filipinos working abroad.

• Ebola fight in Liberia ramps up as U.S. sends marines
• MORE COVERAGE | Photos, videos, stories
• MAP | The spread of the Ebola virus
• Ebola: Infected Spanish nursing aide touched face with glove

While bracing for Ebola, health officials should continue to focus on major health threats, including non-communicable diseases, she said.

Philippine Health Secretary Enrique Ona said authorities will ask more than 1,700 Filipinos working in Liberia, Sierra Leone and Guinea to observe themselves for at least 21 days for Ebola symptoms in those countries first if they plan to return home.

Once home, they should observe themselves for another 21 days and then report the result of their self-screening to health authorities to be doubly sure they have not been infected, he said, adding that hospitals which would deal with any Ebola patients have already been identified in the Philippines.