Human trials to begin on made-in-Canada COVID-19 vaccine you inhale, not inject
TORONTO -- Researchers at McMaster University in Hamilton, Ont., have been approved to begin human trials on two Canadian-made COVID-19 vaccines that are delivered by inhaled aerosol to target the lungs and upper airways.
In a release Tuesday, McMaster said researchers would test the safety and immune potency of the inhaled vaccines during Phase 1 of clinical trials they recently received Health Canada approval to begin. Both inhaled vaccines are intended to act as boosters to be administered to participants who have previously received two doses of a COVID-19 mRNA vaccine such as Pfizer or Moderna’s.
The McMaster vaccines utilize three different SARS-CoV proteins, including the spike protein, and are made to also target parts of the coronavirus that do not change or mutate.
“Activating the immune system against three different proteins, rather than one, should provide better protection against variants of concern,” the release states.
The inhaled vaccine draws on 20 years of research and development by McMaster’s Zhou Xing, who is a co-principal investigator and professor in the department of medicine and the Immunology Research Centre.
“Besides its multi-antigenic vaccine design, our vaccine strategy differs from all of the current first-generation COVID-19 vaccines in the route of delivery. Ours gets delivered into the lung via inhaled aerosol to induce respiratory mucosal immunity, known to provide best protection against respiratory pathogens,” Xing said in the release.
The vaccines were produced at McMaster’s Robert E. Fitzhenry Vector Laboratory, which is one of the few Canadian facilities that has the capacity to develop and produce viral vector vaccines for clinical trials.
At least 30 healthy volunteers will take part in the study which is funded by the Canadian Institutes for Health Research. The researchers will examine how the immune response develops in the lungs and blood of study participants after vaccination and monitor for possible side effects.
Professor of Pathology and Molecular Medicine at McMaster University and Co-Director of the Special Immunology Services and HIV Clinic Dr. Fiona Smaill said in an interview with CTV News Monday the new vaccines are an opportunity to diversify the tools Canada has at its disposal to deal with the COVID-19 pandemic.
“The original vaccines that have been developed have really got us out of a tricky situation 12 months ago, but now I think it’s very important to take time to refine our approaches and to look at some of these new strategies where the [inhaled] vaccinations may be more effective against variants as they evolve and perhaps overall more effective at protecting against infection,” Smaill said.
Smaill said she has done many important clinical trials throughout her career, but the latest vaccine trials have been “the most important ones in terms of moving the research agenda forward.”
Smaill said the trial hopes to begin recruiting participants next week. “My hope and my expectation is that [this trial] will demonstrate this vaccine given as a booster is safe, and… that we can generate immune responses that we believe will be protective against COVID-19,” she said.
Co-principal investigator and Associate Professor at McMaster’s Michael G. DeGroote Institute for Infectious Disease Research Matthew Miller told CTV News in an interview Monday that the inhaled vaccines are an opportunity to “get in front of” the COVID-19 virus.
“I think we want to get ourselves out of that cycle with COVID-19 by designing vaccines that allow us to finally get one step ahead of the virus and protect against variants that may not have even emerged yet,” he said.
Miller said that by stimulating immunity in the lungs through an inhaled vaccine, researchers are able to “leverage some really unique and highly protective qualities of our lungs,” that allows for a much more potent reaction.
“One of the benefits of being able to vaccinate directly in the lungs is that we're able to use a lot less material in order to generate an immune response that's actually much stronger than what we're able to achieve by vaccinating in the arm and…the expectation would be that by lowering the dose of vaccine, we should also be able to avoid some of those adverse effects,” he said.
Smaill said the announcement of human trials “symbolizes that there are Canadian researchers who are really on the cutting edge of vaccine research, particularly vaccine research against COVID-19.”
Professor of Virology and Immunology at Memorial University in Newfoundland, and Vice President of the Canadian Society for Virology Rod Russell told CTV News in an interview Monday that an inhaled vaccine has some perks compared to the ones currently in circulation.
“Directing or administering the vaccine right into the lungs means that the immune response that you make against the vaccine is right there in the lungs. It's not going into the muscle, and then antibodies are made and have to make their way to the lungs…You'd have that sort of immediate immune response right where you need it,” he said.
Echoing Miller, Russell said there was potential for a better immune response in the mucosal areas if a recipient takes an inhaled vaccine.
“We inhale the virus into our nose or into our mouth, and then the infection takes place in the upper respiratory tract… in some people, it moves to lower risk for respiratory tract,” he explained. So again, having a vaccine that that has the response initiated at the site, you know, may actually provide a better response in the long run to or in the short term to the to the virus once you're exposed to it.”
Russell also pointed out the nature of an inhaled vaccine may cut down on the hesitancy of needle-phobic Canadians or children.
“The idea that it’s inhaled, so it’s not as intrusive or it doesn’t feel as intrusive to the body…but more importantly in my opinion is the idea that you’re delivering the vaccine right to where you need it,” he said.