Next-generation, inhaled COVID-19 vaccine enters phase-2 clinical trial

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. So, we're looking to change that by providing robust protection directly at the site of infection."

 Fiona Smaill, Professor, Department of Pathology & Molecular Medicine, McMaster University

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

Smaill says that the study is a randomized placebo-controlled trial, noting that two-thirds of the study's participants will receive the vaccine, while the other third will receive a

placebo. Participants won't know which group they belong to, but the researchers argue that both groups are equally integral to the study.

"Clinical trials, like this one, are the only way to firmly establish the efficacy and safety of novel health products," Smaill says. "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."

"Every medicine or vaccine that we use and trust today has at one point gone through similar clinical trials processes," adds Matthew Miller, director of both the IIDR and Global Nexus at McMaster, and part of the trial study team. "This is a highly regulated process with extensive oversight that ensures the safety of participants and will generate critical data to inform the next steps in development."

Following the study, researchers will move the vaccine into phase-3 clinical trials which will test efficacy in a larger population group and ultimately position the vaccine for market approval.

More information, including how to enrol in the study, is available at aerovax.ca.