Researchers at McMaster University have initiated a phase-2 clinical trial for a next-generation, inhaled COVID-19 vaccine called AeroVax. This study, backed by $8 million from the Canadian Institutes of Health Research (CIHR), aims to evaluate needle-free vaccines designed to offer protection against SARS-CoV-2.
Led by Fiona Smaill and Zhou Xing from the Michael G. DeGroote Institute for Infectious Disease Research (IIDR), the multi-center trial will assess the vaccine’s safety and efficacy in a diverse group of participants. Preliminary findings from earlier studies suggest that the inhaled vaccine may generate stronger immune responses than traditional injected vaccines by directly targeting the lungs and upper airways, the initial points of viral entry.
“While current needle-based COVID-19 vaccines have significantly reduced death and hospitalization rates, they haven’t fully addressed the challenge of recurrent infections,” said Smaill, a professor in the Department of Pathology & Molecular Medicine. “Our goal is to enhance protection right at the site of infection.”
The development of this vaccine is entirely Canadian, with design and biomanufacturing occurring at McMaster’s Robert E. Fitzhenry Vector Laboratory, alongside comprehensive pre-clinical and clinical testing conducted by Canadian experts on Canadian participants at local research sites.
For this trial, the researchers aim to recruit 350 participants from clinical trial locations in Hamilton, Ottawa, and Halifax. Eligibility criteria include:
Completion of at least three doses of an mRNA COVID-19 vaccine
No prior administration of the AstraZeneca vaccine
Absence of COVID-19 infection or vaccination within the three months preceding enrollment
No diagnosed lung disease
Availability for in-person trial visits
Age range of 18 to 65 years
This study will follow a randomised, placebo-controlled design, with two-thirds of participants receiving the vaccine and the remaining third receiving a placebo. Participants will remain unaware of their group assignment, underscoring the importance of both groups in evaluating the vaccine’s effectiveness.
“Clinical trials are essential for confirming the safety and efficacy of new health products,” Smaill explained. “Randomization enables objective comparisons between vaccinated and unvaccinated individuals, providing valuable insights into the vaccine’s protective benefits and potential side effects.”
Matthew Miller, director of both the IIDR and Global Nexus at McMaster, emphasised the rigor of the trial process: “Every trusted medicine or vaccine has undergone similar trials. This highly regulated process ensures participant safety and will generate critical data for future development.”
This study will follow a randomized, placebo-controlled design, with two-thirds of participants receiving the vaccine and the remaining third receiving a placebo. Participants will remain unaware of their group assignment, underscoring the importance of both groups in evaluating the vaccine’s effectiveness.
