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McMaster University Launches Phase-2 Trial of Novel Inhaled COVID-19 Vaccine

• Canadian researchers at McMaster University have begun phase-2 clinical trials for AeroVax, an innovative inhaled COVID-19 vaccine that directly targets the lungs and upper airways where infection begins.

• The $8M CIHR-funded study aims to recruit 350 participants across Hamilton, Ottawa, and Halifax, testing a needle-free alternative that preliminary data suggests induces stronger immune responses than traditional injected vaccines.

• This entirely Canadian-developed vaccine could potentially reduce recurrent infections by providing robust protection at the infection site, with plans to advance to phase-3 efficacy trials following successful completion.

McMaster University researchers have initiated a phase-2 clinical trial for a next-generation inhaled COVID-19 vaccine designed to provide enhanced protection against SARS-CoV-2 by targeting the respiratory system directly.
The AeroVax study, backed by $8 million in funding from the Canadian Institutes of Health Research (CIHR), represents a significant advancement in vaccine delivery technology. Led by Drs. Fiona Smaill and Zhou Xing from the Michael G. DeGroote Institute for Infectious Disease Research (IIDR), this multi-center trial will evaluate both safety and immunogenicity in a broader study population.

Targeting the Respiratory System for Enhanced Protection

Preliminary data from pre-clinical studies and soon-to-be-published phase-1 trial results indicate that the inhaled vaccine may offer superior immune response compared to traditional injectable vaccines. This advantage stems from its direct delivery to the lungs and upper airways—the primary entry points for the SARS-CoV-2 virus.
"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," explains Dr. 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."

Made-in-Canada Vaccine Development

The AeroVax vaccine represents a fully Canadian initiative, from its initial design and biomanufacturing at McMaster's Robert E. Fitzhenry Vector Laboratory to the pre-clinical and clinical testing phases. The entire development process involves Canadian experts, participants, and research facilities.
This domestic approach to vaccine development strengthens Canada's biomanufacturing capabilities and reduces dependency on international supply chains for critical medical countermeasures.

Trial Design and Participant Recruitment

The research team aims to enroll 350 participants across clinical sites in Hamilton, Ottawa, and Halifax. The randomized, placebo-controlled trial will assign two-thirds of participants to receive the vaccine and one-third to receive a placebo.
Eligibility criteria for potential participants include:
  • Prior receipt of at least three doses of an mRNA COVID-19 vaccine
  • No previous administration of the AstraZeneca COVID-19 vaccine
  • No COVID-19 infection or vaccination within three months of enrollment
  • Absence of diagnosed lung disease
  • Availability for in-person trial visits
  • Age between 18 and 65 years
Dr. Smaill emphasizes the importance of the trial's design: "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."

Scientific Rigor and Safety Oversight

The trial adheres to strict regulatory standards with comprehensive safety monitoring. Dr. Matthew Miller, director of both the IIDR and Global Nexus at McMaster and a member of the trial study team, notes, "Every medicine or vaccine that we use and trust today has at one point gone through similar clinical trials processes. 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."

Future Development Pathway

Following successful completion of the phase-2 trial, researchers plan to advance the vaccine to phase-3 clinical trials, which will assess efficacy in a larger population. This progression is essential for eventual market approval and widespread distribution.
The inhaled vaccine platform could potentially address several limitations of current COVID-19 vaccines, particularly in preventing breakthrough infections and reducing transmission. By generating robust mucosal immunity at the primary site of viral entry, the technology may offer more comprehensive protection against respiratory pathogens.
Individuals interested in participating in the AeroVax study can find additional information and enrollment details at aerovax.ca.
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