The first Canadian clinical trials for a possible COVID-19 vaccine will be conducted by a Halifax research team that also participated in trials that ultimately led to an Ebola vaccine.
Health Canada has approved trials for the Canadian Center for Vaccinology at Dalhousie University.
Center director Dr. Scott Halperin said the lab was one of many in Canada and the United States whose work starting in 2014 finally saw an “emergency release” of a vaccine against Ebola used in West Africa before a third phase of clinical trials. had been completed.
Halperin said each lab has done slightly different studies to get the right kind of information before quickly moving on to the second phase and then the third.
“The phase 1 studies were carried out and within six months, the data were available and the phase three studies were launched in West Africa, which then made it possible to stop the epidemic,” he said. he declared during an interview.
Halperin stated that the same emergency release could occur in Canada with a potential COVID-19 vaccine if it were found to be potential and found to be safe, which accelerated a process that usually took several years – five at seven under normal circumstances. .
“It would be something that Health Canada and the Canadian government would have to decide if they wanted to do it. But that is certainly one of the options in the toolkit on what they can do to speed up the process if this or any other vaccine looks promising. “
Halperin pointed out that despite its early use in testing, the Ebola vaccine was not actually licensed as a marketed vaccine until the end of last year.
However, he warns that there is a lot of work to be done before a COVID-19 vaccine can be approved for use.
The Halifax researchers will follow the work of Chinese manufacturer CanSino Biologics, which is already conducting human clinical trials for the vaccine.
Halperin said the first phase of the trial should be underway within the next three weeks after final approval is given by the center’s research ethics board.
Phase 1 will involve fewer than 100 healthy volunteers between the ages of 18 and 55 who will be followed over the next six months.
“We want to make sure the vaccine is safe first for young people before going to people who may be at higher risk,” said Halperin.
Participants receive a dose of vaccine and are followed clinically by a series of blood tests. They are also asked to record their symptoms in a journal so that researchers can get even more information.
“We collect any type of symptom they may experience, whether they think it is related to the vaccine or not,” said Halperin.
Each participant will make between nine and 13 visits to the center during the first phase of the study.
If the initial test group shows a safe immune response to the vaccine, Halperin said the researchers will quickly switch to an expanded second phase study even before the first phase is completed.
It would involve hundreds of people of all ages, including those aged 65 to 85, and would be administered by several other research centers across the country that are part of the Canadian Immunization Research Network.
Halperin said the network was set up by the federal government in 2009 as part of the response to the H1N1 pandemic. He said the intention was to create the infrastructure to respond quickly to an emergency and to conduct early phase clinical trials to make the vaccines available in Canada.
“This is a good test of this (network),” said Halperin of the clinical trials which will be the first of “many more to come.”
Keith Doucette, The Canadian Press
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