Researchers at McMaster University have started a phase-2 clinical trial on a next-generation, inhaled COVID-19 vaccine.
The AeroVax 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.
Led by Fiona Smaill and Zhou Xing, members of the Michael G. DeGroote Institute for Infectious Disease Research (IIDR) at McMaster, the multi-centre trial will evaluate the new vaccine in a broad study group, while also confirming safety.
Findings from pre-clinical studies and the soon-to-be-published data from the phase-1 trial indicate that McMaster’s inhaled vaccine is more effective at inducing immune responses than traditional injected vaccines are, because it directly targets the lungs and upper airways — where the virus first enters the body.
“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,” says Smaill, a professor in the Department of Pathology & Molecular Medicine. “So, we’re looking to change that by providing robust protection directly at the site of infection.”
The new vaccine is entirely Canadian, from design and biomanufacturing at McMaster’s Robert E. Fitzhenry Vector Laboratory to pre-clinical and clinical testing conducted by a team of Canadian experts, with Canadian participants, at Canadian research sites.
For the new trial, researchers hope to include 350 participants from across Canada at clinical trial sites in Hamilton, Ottawa, and Halifax. Those eligible for participation must:
- Have at least three doses of an mRNA COVID-19 vaccine
- Have never received the AstraZeneca COVID-19 vaccine
- Have not had a COVID-19 infection or COVID-19 vaccination within three months prior to enrollment
- Have no diagnosis of lung disease
- Be available to attend trial visits in-person
- Be age 18-65