Canadian-made COVID-19 vaccine to begin human clinical trials
A Canadian-made COVID-19 vaccine will begin human clinical trials on Tuesday.
Toronto-based Providence Therapeutics announced it has begun dosing the volunteers in human clinical trials of its COVID-19 vaccine.
The vaccine, PTX-COVID19-B, is a messenger RNA (mRNA) vaccine and is “the first fully made-in Canada COVID vaccine to reach this stage of development.”
Subjects will be monitored for 13 months from the beginning of the trial. The company says there will be enough data accumulated by April 2021 to move into Phase 2 of the process in May 2021 — pending regulatory approval.
The clinical study of this vaccine will be carried out in Toronto with 60 volunteers between the ages of 18-65, enrolled in the Phase 1 study and divided into three groups of 20. Three different dose levels of the vaccine will be administered together with a placebo in each group.
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The study will test the person’s immunity to the vaccine, as well as its safety for human use.
“We are thrilled to begin human clinical trials of PTX-COVID19-B. Having a made-in-Canada solution to address the global COVID-19 pandemic will augment the reliability of vaccine supply for Canadians, contribute to the global vaccine supply and position a Canadian company on the global stage as a contributor to the solution,” says Brad Sorenson, CEO of Providence Therapeutics in a statement.
“We would also like to extend our gratitude to the volunteers who have stepped forward to take part in this important clinical trial.”
Preclinical studies of the vaccine showed that there were “robust” antibody responses against the spike (S) protein of COVID-19 that were “highly effective at neutralizing the virus in multiple assays.”
Pending positive results, commercialization is estimated to begin at the end of 2021 or early 2022.
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