Clinical trials are a vital part of vaccine research. They examine how well a vaccine protects against disease and what side effects, if any, it might have. Without regulated clinical trials, vaccines cannot be approved for use in Canada.
CCfV – and CCfV volunteers – make significant contributions to clinical trials in Canada, helping progress infectious disease prevention and advance immunization for a healthier world.
An essential part of vaccine research
A vaccine is first tested in the lab and studied in animals, which provides initial information about how well it works and possible side effects. Only clinical trials allow researchers to evaluate how safe and effective a vaccine is in humans.
Every vaccine in Canada must go through a series of clinical trials studying safety and effectiveness of the vaccine in volunteers. Conducting these trials in stages allows researchers to carefully manage the risks of negative reactions to the vaccine. They evaluate how a small group of healthy adults respond first. Then, if the first stage is successful, the study can slowly introduce the vaccine to more people.
Phase 1 clinical trials evaluate the vaccine in a small number of healthy adult volunteers to assess safety, immune response, and/or what the best dose of the vaccine is.
Phase 2 clinical trials evaluate the vaccine in a larger number of volunteers after phase 1 has been completed. These trials continue to evaluate safety and the immune response to the vaccine. This phase may also assess the vaccine in people from the group the vaccine is meant for, such as children or people with underlying health conditions.
Phase 3 clinical trials evaluate how well the vaccine prevents the targeted infection in a larger and more varied or diverse group of people. They can involve thousands of volunteers at multiple study sites.
Health Canada examines the results of these studies to decide whether a vaccine should be rolled out to the public. Once a vaccine is approved for use, it continues to be monitored for safety and effectiveness. This may be called Phase 4.
CCfV’s contributions to clinical trials in Canada
Since the 1990s, the Canadian Center for Vaccinology has made significant contributions to vaccine clinical trials in Canada.
CCfV specializes in first-in-human studies, with nearly 30 industry sponsored Phase I studies conducted or in progress. These trials have included numerous candidate vaccines developed in response to outbreaks. The Center led a Phase I clinical trial for an Ebola vaccine in response to the 2014 West African Ebola virus epidemic, conducted a clinical trial of an H1N1 vaccine in 2009, and was involved in over 30 COVID-19 studies, including Phase 1 clinical trials for five domestic vaccine candidates.
In the last decade, CCfV trials have evaluated vaccine candidates targeting H5N1, RSV, influenza, pneumococcus, CMV, Lyme disease, varicella-zoster virus, pertussis, and more. This work represents just a small portion of our impact on infectious disease prevention in Canada.
Volunteer with impact
Clinical trials wouldn’t be possible without the contributions of the people who choose to take part in research. In the last decade, more than 1000 volunteers have participated in clinical trials at CCfV alone. Additional participants took part in many of these trials at other sites across Canada.
As we look ahead to the next decade of clinical trials at CCfV, we know that volunteers will continue to play a crucial role in contributing to a healthier world.
Want to make an impact with us? You can find a recruiting clinical trial here or learn more about participating in research.