A new, Canadian-made, inhalable COVID-19 vaccine is set to enter Phase 2 human trials.
The vaccine is being developed at McMaster University in Hamilton, Ontario.
“There is an urgent need to develop new, more effective next-generation vaccine strategies,” said McMaster’s vice president for research, Dr. Karen Mossman, in a media release. “As international leaders in respiratory mucosal immunity and vaccines, our researchers pivoted quickly with the arrival of the COVID-19 pandemic, building on an already strong inhaled vaccine research program focused on tuberculosis.”
Preclinical trials have already shown that the inhaled aerosol vaccine may be more effective at generating an immune response than injected vaccines, in part because it targets the upper respiratory tract and lungs, where respiratory viruses such as COVID-19 enter the body, according to the release.
During phase 1 human trials, researchers evaluated dosage and safety in 30 healthy volunteers who had already received at least two injections of an mRNA vaccine, such as those made by Pfizer and Moderna.
In Phase 2, which should begin in the coming months, researchers will monitor the safety and immune responses of up to 500 participants, including those with other health problems, who received at least three doses of the mRNA vaccine. Phase 2 will be conducted with the help of $8.2 million in new federal funding from the Canadian Institutes of Health Research.
Dr. Fiona Smile is a professor in McMaster’s Department of Pathology and Molecular Medicine and one of the leaders of the clinical trials, which also include collaborators from Dalhousie University in Nova Scotia and the University of Ottawa.
“If we can show that the new inhaled vaccine is as safe and effective as we expect, the impact will be significant for human health, medical costs and improved quality of life,” Smail said.
The vaccine is designed to target parts of the coronavirus that don’t change or mutate, potentially making it more effective against new variants.
“The current vaccination strategy against COVID-19 has us constantly chasing the virus, and it’s clear that we just can’t keep up,” explained Matthew Miller, scientific director of the McMaster Infectious Disease Research Institute and one of the trial’s leaders. “Our team has developed a vaccine strategy aimed at circumventing this cycle and the need to constantly update these vaccines by targeting parts of the virus that are resistant to mutation and inducing strong immunity at the site where infection actually occurs.”
Amid pandemic fatigue and a dwindling number of boosters, researchers hope the inhaled vaccine will be more convenient and attractive than needles, and they expect their work will help advance inhaled vaccines for other respiratory infections such as tuberculosis and influenza .
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