A Nova Scotia laboratory working on a vaccine for COVID-19 has been given the green light from Health Canada to proceed with its plan for human trials.
"The clinical team is putting together the final documents for Health Canada final approval, to move that into the clinic," says Marianne Stanford, the vice-president of research and development of IMV Inc. "We're putting all the pieces together to get this done."
IMV is a biopharmaceutical company with labs in Dartmouth, N.S. The company started working on a vaccine for the novel coronavirus as soon as the World Health Organization declared the pandemic.
IMV researchers have spent the past several months working on an accelerated timeline, modifying the company's existing immunotherapy technology to deliver a COVID-19 vaccine into the human body.
On May 21, the company selected a candidate vaccine out of a series of formulations tested on animals.
Health Canada has now approved IMV's design for its Phase 1 clinical study, which will test the vaccine in 84 healthy adults.
Phase 1 will test the safety of the vaccine itself. The study is unique in that it will test the vaccine on two age groups -- adults between 18 and 55 years old and adults 56 years of age and older. Two doses of the vaccine will be tested on both groups.
"We're one of the first to focus in that [older] age group for initial clinical trial," says Stanford, "and I think that's really based on the fact that we have previous data with that age group."
Batches of IMV's vaccine have already been made at a manufacturing facility in the United States. The plan is to start testing it on people through the Canadian Center for Vaccinology (CCV) in Halifax this summer, with results expected this fall. The CCV will recruit subjects, administer the vaccine, and monitor the results.
IMV says, if the trials are successful, it hopes to move to Phase 2 trials later this year. That phase would look at the ability of the vaccine to trigger the desired immune response.
The IMV vaccine is one of about half a dozen being developed in Canada that are moving quickly on to human testing, but IMV's vaccine is unique in several ways.
While many are made in eggs -- or in a case in Quebec -- in plants, IMV's is entirely synthetic, which the company says makes the vaccine easier to make.
It also requires much smaller doses, meaning a little can go a long way.
For infectious disease expert Dr. Lisa Barrett of Dalhousie University and the Nova Scotia Health Authority, it is all encouraging news.
"We want to get there as fast as we can, with safety, and with a really fantastic vaccine, those are the two things we want to get, so if we go too fast sometimes, we miss on either one, and we don't want to do that," says Dr. Barrett.
Dr. Barrett says, while it is good news that several Canadian companies are heading into Phase 1 human trials, vaccines must pass three phases of testing in order to be administered to the general population.
"So to have multiple candidates for a vaccine, even in the early stage, Phase 1, at this point, within only months of having discovered this virus, is good," she says. "But basically that means small numbers of people are going to get the vaccine, to make sure it's safe to be in humans, and then it has to go through two other phases before it gets to go into the general population."
Stanford is optimistic.
"I think it's one of those things where I've never seen a field move so quickly and collaboratively," she says. "So I'm very hopeful by what I'm seeing."
A previous version of this article erroneously stated that Phase 2 trials would test the vaccine on patients who have tested positive for COVID-19. In fact, Phase 2 trials will look look at the ability of the vaccine to trigger an immune response.