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Phase 1 Trials
Clinical trials of vaccines are CCfV has conducted 17 Phase I
conducted at CCfV according to clinical trials since 2000.
the prescribed phases, each of
which answers a separate research
question. At the end of 2014, CCfV had a unique
opportunity to test a Phase I Ebola vaccine
Phase I: testing a new vaccine in a small group (VSV-EBOV) originally developed by the
of people (e.g. 40) for the first time. This is National Microbiology Laboratory in Winnipeg.
primarily a safety test to determine a safe CCfV conducted this trial on behalf of the
dosage range and identify side effects. Canadian Immunization Research Network.
This was the only Phase I trial of this vaccine
Phase II: following a Phase I test, the vaccine is in Canada. The Ebola outbreak in West Africa
tested in a larger group of people (e.g. 100+) to was at its peak at the time, a rapid Phase I trial
see if it is effective as well as safe. was expedited by the Government of Canada,
jointly funded by the Canadian Institutes
Phase III: a vaccine which has already passed of Health Research and the Public Health
through Phases I and II is then tested in large Agency of Canada. Only 40 participants
groups of people (e.g. 1000+) to confirm its were eventually enrolled in the trial although
effectiveness, monitor side effects, and collect hundreds of people from the Halifax area
more information so it can be used safely and generously volunteered because they wanted
effectively in large populations. to help the people of West Africa. Media
interest was unprecedented for a clinical trial at
Phase IV: this final, ongoing testing gathers CCfV; investigators and volunteer participants
more information on the vaccine’s effect in were interviewed at almost every stage. The
various populations, and any side effects participants are now being monitored, and then
associated with long-term use. the data will be analyzed and reported.
6 Canadian Center for Vaccinology
Clinical trials of vaccines are CCfV has conducted 17 Phase I
conducted at CCfV according to clinical trials since 2000.
the prescribed phases, each of
which answers a separate research
question. At the end of 2014, CCfV had a unique
opportunity to test a Phase I Ebola vaccine
Phase I: testing a new vaccine in a small group (VSV-EBOV) originally developed by the
of people (e.g. 40) for the first time. This is National Microbiology Laboratory in Winnipeg.
primarily a safety test to determine a safe CCfV conducted this trial on behalf of the
dosage range and identify side effects. Canadian Immunization Research Network.
This was the only Phase I trial of this vaccine
Phase II: following a Phase I test, the vaccine is in Canada. The Ebola outbreak in West Africa
tested in a larger group of people (e.g. 100+) to was at its peak at the time, a rapid Phase I trial
see if it is effective as well as safe. was expedited by the Government of Canada,
jointly funded by the Canadian Institutes
Phase III: a vaccine which has already passed of Health Research and the Public Health
through Phases I and II is then tested in large Agency of Canada. Only 40 participants
groups of people (e.g. 1000+) to confirm its were eventually enrolled in the trial although
effectiveness, monitor side effects, and collect hundreds of people from the Halifax area
more information so it can be used safely and generously volunteered because they wanted
effectively in large populations. to help the people of West Africa. Media
interest was unprecedented for a clinical trial at
Phase IV: this final, ongoing testing gathers CCfV; investigators and volunteer participants
more information on the vaccine’s effect in were interviewed at almost every stage. The
various populations, and any side effects participants are now being monitored, and then
associated with long-term use. the data will be analyzed and reported.
6 Canadian Center for Vaccinology
