The Phase 1 study, which ran from 2022 to 2024 at McMaster University in Hamilton, measured the safety and immunogenicity of the new vaccine in a cohort of 36 healthy adults. The study results were published recently Nature Communications.
The research team reports that the Phase 1 human trials yielded promising early results for the vaccine, which is administered directly to the lungs as an inhaled mist, rather than intramuscularly via injection.
The inhaled vaccine provided study participants with three layers of mucosal defence in the respiratory tract, where there is typically very little protection against the virus, even after mRNA vaccination or COVID-19 infection.
“Even though they have significantly reduced incidence of death and hospitalization, the current COVID-19 vaccines have generally not provided protection against breakthrough infections,” says Fiona Smaill, professor emerita in the Department of Pathology and Molecular Medicine at McMaster. “Our studies suggest that this is in part due to their inability to provide strong mucosal immunity in the lower respiratory tract, something our inhaled vaccine does quite well. This trial has made a strong case for inhaled vaccines to become a key tool in the prevention of future outbreaks and pandemics.”
The new publication serves as independent, peer-reviewed validation of the research team’s discoveries, which have already led to the approval of now-underway Phase 2 trials.
The trial also helped the research team determine optimal dosage for the vaccine, which, along with safety and effectiveness, will continue to be evaluated during the ongoing Phase 2 human trials.
This inhaled vaccine platform, which was established at McMaster decades ago to fight tuberculosis, is now CP2H’s flagship translational research initiative, transforming the technology to protect against COVID-19.
CP2H brings together leading researchers and infrastructure from uOttawa, OHRI and McMaster. This has enabled rapid progress from discovery to clinical trials, leveraging the unique strengths of each institution in immunology, translational research and biomanufacturing.
Matthew Miller, CP2H scientific co-director alongsideJohn Bell from the Ottawa Hospital Research Institute, says that the success of the inhaled vaccine program exemplifies how interdisciplinary and intersectoral collaboration, coupled with sustained investment in research infrastructure, can catalyze the development of important new health solutions.
“From concept and study design to biomanufacturing and clinical trials, every aspect of this study has been conducted locally, and through CP2H, we intend to similarly advance new drugs and diagnostics to the point of clinical trials and beyond.”
Brian Lichty, director of McMaster’s Robert E. Fitzhenry Vector Laboratory, adds that these vaccine trials were powered by recent support for life sciences research and biomanufacturing in Canada.
“With the recent funding from both the federal and Ontario governments to build a new, enhanced biomanufacturing facility at McMaster, our ability to support future clinical trials of all sorts will dramatically expand in the near future.”
Article previously published by McMaster University