Next-generation inhaled COVID-19 vaccine enters Phase 2 clinical trial

Next-generation inhaled COVID-19 vaccine enters Phase 2 clinical trial

Researchers at McMaster University have launched a Phase 2 clinical trial of a next-generation inhaled COVID-19 vaccine.

The Aerovax trial, supported by $8 million in funding from the Canadian Institutes of Health Research (CIHR), will test needle-free vaccines designed to provide protection against 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 multicenter study will evaluate the new vaccine in a broad study group while confirming safety.

Results from preclinical studies and soon-to-be-released Phase 1 trial data show that McMaster's inhaled vaccine is more effective at inducing immune responses than traditional vaccines because it directly targets the lungs and upper respiratory tract - where the virus enters the body first.

While current needle-based Covid-19 vaccines have prevented a tremendous amount of death and hospitalization, they have not changed many of the experiences of people with recurrent infections. So we want to change this by providing robust protection directly at the site of infection. “

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

The new vaccine is entirely Canadian, from design and biomanufacture in McMaster's Robert E. Fitzhenry Vector laboratory to preclinical and clinical testing conducted by a team of Canadian experts with Canadian participants at Canadian research states.

For the new study, researchers hope to enroll 350 participants from across Canada at clinical trial sites in Hamilton, Ottawa and Halifax. Those eligible to participate must:

• Mindestens drei Dosen eines mRNA-Covid-19-Impfstoffs haben
• Habe nie den AstraZeneca Covid-19-Impfstoff erhalten
• Habe innerhalb von drei Monaten vor der Einschreibung keine Covid-19-Infektion oder eine Covid-199-Impfung gehabt
• Keine Diagnose einer Lungenerkrankung haben
• Seien Sie zur Verfügung, um persönliche Testbesuche zu besuchen
• 18-65 Jahre alt sein

According to Smaill, the study is a randomized, placebo-controlled trial, he notes

Placebo. Participants will not know which group they belong to, but the researchers argue that both groups are equally integral to the study.

“Clinical studies like this are the only way to firmly establish the effectiveness and safety of novel health products,” says Smaill. “Randomization allows an objective comparison between those who received the vaccine and those who did not, which can tell us a lot about the level of protection of the vaccine and their side effects.”

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

After the study, researchers will move the vaccine into Phase 3 clinical trials, which will test effectiveness in a larger population and ultimately position the vaccine for market allocation.

For more information, including how to enroll in the trial, visit aerovax.ca.

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