Human trials for 2 inhaled COVID-19 vaccines to start in Hamilton in 2022

Human trials are set to begin early next year at an Ontario universityfor two next-generation COVID-19 vaccines that can be inhaled.

Fiona Smaill isa professor of pathology and molecularmedicine at McMasterUniversity in Hamilton and lead researcher for the clinical trials. Shesaid on Tuesday thatboth vaccines, which would be the first inhaled vaccines, are "approved for study in Canada."They're designed to combat variants of concern and aredelivered by inhaled aerosol, targeting the lungs and upper airways, where respiratory infections begin.

"The novel part of our vaccine is that we're administering it by inhaled aerosol, and so the immune response that is generated in the lungs," Smaill told CBC Hamilton.

"Not only do we have the vector that is unique, but we also have the route of administration and the generation of what we call a mucosal immunity, which we believe is a very effective form of immunity against respiratory viruses like COVID."

Health Canada recently gave the go-ahead for the clinical trials to start, Smaill told CBC News.

WATCH |Prof.Fiona Smaill of McMaster University discussthe new vaccine trials:

McMaster University developing inhaled aerosol COVID-19 vaccines

3 years ago

Duration 7:54

Professor Fiona Smaill of McMaster University in Hamilton, Ont., is running trials for two new inhaled aerosol drugs intended as COVID-19 booster vaccines.

The vaccines, which express three different SARS-CoV-2 proteins, including the distinctive spike protein, are designed to also target other parts of the virus that do not change or mutate, Smaill said.

"We believe that by including the three proteins that we will more likely have a broader immune response that will address some of the challenges with the variants of concern."

The researcher said they expectto start enrolling participants within the next two weeks,and begin administering the vaccine in the new year.

"We're looking for healthy volunteers who have had two doses of an mRNA vaccine or the Pfizer or Moderna vaccine at least the second one three months ago," Smaill said.

Potential volunteers, who must be healthy, would be between ages18 and 65, with no underlying health problems orissues with lung function.

Study to include at least 30 healthy volunteers

The researchers said they will examine how the immune response develops in the lungs and blood after vaccination and monitor for possible side-effects.

According to a news release announcing the trials, researchers are comparing two strains of weakened adenovirus as platforms for the vaccines: one is made with a human adenovirus, the other is a chimpanzee adenovirus.

"In their natural form, adenoviruses cause respiratory infections such as the common cold, and in rare cases can cause a lung infection such as pneumonia. In their weakened form, they do not spread disease, but can be customized to serve as vehicles, or vectors, to trigger targeted immune responses," the news release said.

Smaill said the human adenovirus"has been well characterized as a viral vector," whilethe chimpanzee adenovirusis used by AstraZeneca and J&Jin their COVID-19 vaccines.

"We've got these two different adenovirus vectors that wethen inserted the genes for the three proteins the spike protein, as well as the polymerase protein and anuclear protein," she told CBC News.

At least 30 healthy volunteers will take part in the study, which is being funded by the Canadian Institutes for Health Research.

Smaill said if Phase 1 is successful, the team has manufactured sufficient vaccine doses to move forward with much larger clinical trials, which could potentially lead to broader use.

"Assuming that we see no safety signals and we are comfortable with the dose that's been chosen, we would then enrola large number of individuals in a Phase 2 study, managing the study design depending on how things evolve with the goal of getting support tobe able to roll this type of technology out to a wider population," Smaill told CBC News.

Matthew Miller, an associate professor with McMaster's Michael G. DeGroote Institute for Infectious Disease Research and co-principal investigator, said the university has along history studyingadenoviruses.

"This human trial builds on that pioneering work, and in addition to addressing an issue of tremendous public health importance, will also advance our fundamental understanding of how to use these viruses most effectively as vaccine vectors."