Canada Begins Ebola Vaccine Trial

 Experimental Ebola vaccine developed by Public Health Agency of Canada

OTTAWA, Nov. 14, 2014 /CNW/ - The Honourable Rona Ambrose, Minister of Health, today announced the launch of a Canadian Phase I clinical trial for Canada's Ebola vaccine (VSV-EBOV). The trial will be led by the Canadian Immunization Research Network (CIRN) and will take place in Halifax, Nova Scotia.

In this trial, jointly funded by the Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC), the experimental vaccine will be tested on a small group of people to assess its safety, determine the appropriate dosage, and identify any possible side effects. The trial will test whether lower doses of the vaccine can induce an immune response in an individual and will also generate valuable information about the use of the vaccine in older adults.  The vaccine does not contain a live Ebola virus. There is no risk that volunteers could contract the Ebola virus through participation in the trials.

This vaccine trial is taking place concurrently with the trials in the United States in an effort to move onto further clinical trials in larger populations as quickly as possible. Trial results are expected in early 2015. Information from the trials will be shared with the international community as part of the global response to this crisis. In prior testing, the vaccine already showed promising results in animal research.

The Government of Canada is committed to supporting international efforts to control the Ebola outbreak and ensuring that appropriate precautions and measures are in place to protect Canadians.

Quick Facts

• CIHR is the Government of Canada's health research investment agency. It supports more 13,200 researchers and trainees across Canada.
• The Canadian Immunization Research Network (CIRN) creates new capacity for timely evaluation of vaccines for a variety of infectious diseases, improves immunization programs and coverage nationwide, and builds strong links between the research community and key decision makers.
• On November 3, 2014, the Government of Canada committed $23.5 million to support further research and development of Ebola medical countermeasures – namely Canada's Ebola vaccine and monoclonal antibody treatments. This funding will be used to support vaccine and treatment clinical trials in West Africa.
• The VSV-EBOV vaccine is the product of more than 10 years of scientific research by Public Health Agency of Canada scientists at the National Microbiology Laboratory.
• This trial will complement others already underway, including one at the Walter Reed Army Institute of Research in Silver Spring, Maryland, and one at the National Institutes of Health in Bethesda, Maryland. The Canadian trial will examine lower dosing levels as well as the effect of the vaccine on older populations.
• The VSV-EBOV vaccine does not contain a live Ebola virus. The vaccine only contains a portion of the protein covering the virus that would help the immune system produce antibodies. There is no risk that volunteers could contract the Ebola virus through participation in the trials.
• Canada has committed a total of over $65 million to the global efforts to support health, humanitarian, and security interventions to address the spread of the disease.
• Canada has shipped 800 vials of the VSV-EBOV vaccine to the World Health Organization to help combat the outbreak in West Africa.
• There has never been a case of Ebola in Canada.

Quotes

"Canada remains at the forefront of the global effort to fight this outbreak. The beginning of the Canadian Phase 1 clinical trials is an important step toward the development of Canada's Ebola vaccine - the product of Canadian innovation and hard work. We're confident that, if proven to be safe and effective in humans, it can be used in the near future to prevent the spread of this devastating disease."
Honourable Rona Ambrose
Minister of Health

"Canadian health researchers are recognized worldwide for their considerable expertise and leadership in carrying out high quality clinical trials. This trial demonstrates the commitment and collaborative spirit of the Canadian health research community and its capacity to rapidly mobilize in response to a global crisis."
Dr. Alain Beaudet
President, Canadian Institutes of Health Research

"Canada's experimental Ebola vaccine is the result of years of research and hard work by Canadian scientists. The results of this clinical trial will offer us valuable data about the safety and effectiveness of our vaccine and will hopefully provide us with the information we need to proceed with further clinical trials in the countries most affected by Ebola.
Dr. Gregory Taylor
Chief Public Health Officer of Canada 

"The clinical trial will assess the safety and immune response to this new Ebola vaccine. The vaccine contains an Ebola virus protein that the immune system will respond to and produce antibodies that provide protection against Ebola".
Dr. Scott Halperin
Director, Canadian Center for Vaccinology and lead investigator, Canadian Immunization Research Network (CIRN)

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Fact Sheet – CIHR Clinical Trial on Canada's Ebola vaccine (VSVG-EBOV)

Fact Sheet – Canada's experimental vaccine for Ebola

Associated Links

Canada's Public Health Response to Ebola

Clinical Trials and Drug Safety

Canadian Immunization Research Network

The Canadian Institutes of Health Research (CIHR) is the Government of Canada's health research investment agency. CIHR's mission is to create new scientific knowledge and to enable its translation into improved health, more effective health services and products, and a strengthened health care system for Canadians. Composed of 13 Institutes, CIHR provides leadership and support to more than 13,200 health researchers and trainees across Canada. www.cihr-irsc.gc.ca

Fact Sheet – CIHR Clinical Trial on Canada's Ebola vaccine (VSV-EBOV)

Through the Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC), $300,000 has been provided for a clinical trial on Canada's Ebola vaccine. The vaccine, developed at PHAC's National Microbiology Laboratory in Winnipeg, Manitoba, will be tested by the Canadian Immunization Research Network (CIRN) on a small number of volunteers in Halifax, Nova Scotia.

In this trial, the experimental vaccine will be tested on a small group of people to assess its safety, determine the appropriate dosage, and identify any side effects. It will include 40 healthy participants between the ages of 18 and 65. Each participant will be meticulously monitored during the trial period. The VSV-EBOV vaccine does not contain a live Ebola virus. The vaccine only contains a portion of the protein covering the virus that would help the immune system produce antibodies. There is no risk that volunteers could contract the Ebola virus through participation in the trials.

This vaccine trial is taking place concurrently with the trials in the United States in an effort to move onto further clinical trials in larger populations as quickly as possible. In prior testing, the vaccine showed promising results in multiple animal models. The Canadian trial will generate information about the results of the vaccine in older adults, as different age groups may have different outcomes to Ebola virus. The Canadian trial will also test lower doses of the vaccine, both to try and achieve maximal protection while reducing side effects, and to stretch the number of people that can be vaccinated with existing supplies of the vaccine. Trial results are expected in early 2015.

Information from the trials will be shared with the international community as part of the global response to the Ebola crisis.

Several Government of Canada departments and agencies, along with global partners, have also begun planning for further clinical trials in larger populations of healthy adults.

About CIRN
The Canadian Immunization Research Network (CIRN) was created in 2014 following a funding call by CIHR and PHAC for a research network examining a wide range of vaccine-preventable diseases. CIRN received $6.6 million in funding over 3 years from CIHR and PHAC. CIRN builds on the strengths of the PHAC/CIHR Influenza Research Network (PCIRN) established in 2009 to consolidate the existing expertise in vaccine evaluation; increase the capacity to rapidly test candidate vaccines; create and strengthen links and facilitate knowledge exchange amongst vaccine researchers and decision makers, and train the next generation of pandemic preparedness and influenza researchers.

About the Canadian Ebola Vaccine (VSV-EBOV)
VSV-EBOV is currently one of three experimental Ebola vaccines sufficiently developed at this point to be tested in humans. The vaccine has undergone very promising and extensive testing in multiple animal models. It was developed by researchers at the Public Health Agency of Canada's National Microbiology Laboratory (NML).

Vaccines have a proven track record to protect humans against deadly infectious diseases. Vaccination leads to the generation of antibodies and the development of immune cellular responses. The antibodies and immune responses attack the infectious agent leading to the neutralization and elimination of the infectious agent such as Ebola, when exposed. Current data indicates that when VSV-EBOV is administered, it induces an immune response that protects against infection by the Ebola virus.

For more information on the clinical trial: http://www.centerforvaccinology.ca/study/ebola-vaccine-study/

SOURCE: Canadian Institutes of Health Research

Contacts: Michael Bolkenius, Office of the Honourable Rona Ambrose, Federal Minister of Health, [phone]; David Coulombe, Media Relations, Canadian Institutes of Health Research, [phone]; Media Relations, Public Health Agency of Canada, [phone]