Researchers at McMaster University in Canada are testing a next-generation Covid-19 vaccine and have started a phase-2 clinical trial.
According to a press release on 10 March, the study supported by $8M in funding from the Canadian Institutes of Health Research (CIHR) will test needle-free vaccines developed to provide protection from SARS-CoV-2.
The trial is aimed at evaluating the new vaccine in a broad study group, while also confirming safety.
Excellent outcomes
The results from the pre-clinical studies and phase-1 trial indicate that the inhaled vaccine is more effective at inducing immune responses than traditional injected vaccines, because it directly targets the lungs and upper airways where the virus first enters the body.
Commenting, leader of the study group, Fiona Smaill, a professor in the Department of Pathology & Molecular Medicine said:
“While the current, needle-based COVID-19 vaccines have prevented a tremendous amount of death and hospitalization, they haven’t really changed a lot of people’s experience with getting recurrent infections. So, we’re looking to change that by providing robust protection directly at the site of infection.”
The researchers hope to include 350 participants from across Canada at clinical trial sites in Hamilton, Ottawa, and Halifax.
According to Smaill, the study is a randomized placebo-controlled trial, with only two-thirds of the study’s participants receiving the vaccine, while the other third will receive a placebo. Smaill further stated that:
“Clinical trials, like this one, are the only way to firmly establish the efficacy and safety of novel health products. Randomization allows for objective comparison between those who received the vaccine and those who didn’t, which can tell us a lot about the level of protection the vaccine could provide and its side effects.”
After this phase is concluded, the researchers intend to proceed to phase-3 clinical trials which will test efficacy in a larger population group, which will get the vaccine ready for market approval.
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