COVID-19 Vaccine Human Clinical Trials Set to Begin

Farmscape for January 7, 2021

The Vaccine and Infectious Disease Organization is scheduled to begin human clinical trials of its new COVID-19 vaccine within the next week.
Just before Christmas VIDO-InterVac, the Vaccine and Infectious Disease Organization at the University of Saskatchewan, received approval from Health Canada to begin human clinical trials of its protein subunit vaccine to protect against COVID-19.
Dr. Volker Gerdts, the Director and CEO of VIDO-InterVac, says this will be a combined phase-1, phase-2 clinical trial that will begin with phase one in Halifax before moving to multiple sites across Canada for phase-2.

Clip-Dr. Volker Gerdts-VIDO-InterVac:
Phase-1 typically just looks at the safety of the vaccine.
It looks at any unwanted reactions to the vaccine if there is any.
What we're doing is we have three age groups, three arms if you want involved with this, starting with a middle ag, so 18 to 54.
Then there's two age groups that are above that, so from 55 to 65 and then above 70.
Those are suggestions that were made by Health Canada, to add an older group to it.
That phase-1 involves 108 individuals that will be enrolled in the phase-1.
Then we go into a phase-2 which then is also looking at, how well does the vaccine induce an immune response?
Are we getting the immune response that we're looking for?
For that we continue with the same age groups but we have various doses of the vaccine to see which one works best in humans and so now we're enrolling hundreds of volunteers.
The absolute number is not identified yet, as that will change as the data becomes available but it is in the range of several hundreds of individuals.

Dr. Gerdts notes all animal studies required to demonstrate the safety and efficacy of the vaccine prior to human trials have been completed and there have been no concerns what so ever regarding the safety of the vaccine.
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Bruce Cochrane.

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