Quebec-based company starts Phase 3 vaccine trial at Red Deer research clinic
EDMONTON -- A Canada-based company has selected a Red Deer research clinic to participate in its late-stage COVID-19 vaccine study.
Medicago, a biopharmaceutical company based in Quebec City, focuses on developing novel vaccines using plant-based technology. The company’s vaccine candidate is currently in Phase 3 clinical trials.
“They introduce the genetic material into a plant and then the plant is basically a little factory and grows and then the virus-like particles get harvested from the leaves,” said the study’s investigator and general practitioner, Dr. Morné Odendaal.
The virus-like particles mimic the target virus – in this case the coronavirus – so they are easily recognized by the immune system. However, the virus-like particles contain no genetic material, so they are “non-infectious and unable to replicate.”
“Your immune system will respond to that and build antibodies, but it’s super safe simply because it’s not actual virus genetic material that’s introduced into the body,” Odendaal said.
So far, Medicago is the only Canadian-based company undergoing a Phase 3 COVID-19 vaccine study. Odendaal said getting this far into a study is a rigorous process.
“You have to show in your Phase 1 and Phase 2 trial that you have safety data,” Odendaal said.
“Medicago, with their vaccine, has done very well with that.”
The Phase 3 study is being conducted across 10 countries and went through an expedited review by the Health Research Ethics Board of Alberta’s Clinical Trials Committee who approved for the study to be conducted in Alberta. The CARe Clinic in Red Deer is the first site in Western Canada to be selected to participate largely in part due to Red Deer’s central location.
“Patients from Calgary, patients from Edmonton, patients from central zone, all have equal access to be able to participate in a trial right here in Alberta,” Odendaal said.
Red Deer resident Jason Ragan volunteered to be a part of the late-stage study. He said he heard about it from a friend in Calgary and felt it was his duty to sign up.
“I’ve always believed in the importance of science and doing things the proper way through the scientific method,” Ragan said.
“It’s something that is important to me so, I wanted to be a part of the study.”
Recently, Health Canada accepted an application from Medicago for a real-time review of its vaccine. It will allow Medicago to submit clinical safety and efficacy information as it becomes available, to Health Canada, who will review the data immediately to accelerate the overall review process. However, Health Canada will not authorize any vaccine until is has received the complete evidence on the safety, efficacy and quality of the COVID-19 vaccine candidate.
“As a physician, we want every person in Canada to have access, right now, to a vaccine, and I think this will just give us such a better opportunity to achieve that,” Odendaal said.
If approved, Medicago expects to produce 80 million doses of the vaccine in 2021, and more than one billion doses per year, once it completes construction of its large-scale factory in Quebec. The study is looking for healthy adults, aged between 18 and 65. To sign up or to learn more, visit www.careclinicrd.ca or call 587-815-0803.