“Altruistic” Montreal residents are wanted for a examine with the COVID-19 vaccine developed by Medicago in Quebec
MONTREAL – The finish line is finally in sight for the Montreal researchers conducting clinical trials of Medicago’s COVID-19 vaccine candidate, with final testing scheduled to begin next week at a center on the West Island.
Now all it takes the Montreal team to move on to Phase 3 is 50 people who volunteer to get a stab. Recruiting participants will not be an easy task.
How do you appeal to someone to sign up for a blind study, which means people don’t know if the syringe contains the Medicago candidate vaccine or a placebo?
This dilemma is compounded by the fact that the volunteer in question may soon be eligible for an approved vaccine as the Quebec adoption gains momentum.
The answer is they “call for a level of altruism,” said the director of the MUHC vaccine study center.
“In this case, we say that while no one is going to force you to do anything, we are asking people to think about it and be ready to possibly get vaccinated a little later than they otherwise might not have been in the study,” said Dr. Michael Libman.
The person’s ability to exercise free will “is an essential thing and one of the reasons we don’t pay people,” said Libman, “because we don’t want coercion here.”
You won’t be too moody who answers, said Libman with a smile. “We are looking for everyone who is not vaccinated!”
The caveat is that there are certain health restrictions. For example, some people with underlying medical conditions might not be eligible.
Anyone interested in participating in the development of a new Medicago vaccine is invited to call the coordinators at 514-624-7855. Or send an email to Giuliana Alfonso at [email protected]
“We will answer all of your questions. We are very excited to speak to you … and you can make your own decision, ”said Libman.
CONTINUING YOUR FATHER’S PUBLIC HEALTH LEGACY
While the Montreal branch of the Medicago trial begins next week, some in Quebec City received their first syringe on Monday.
Resident Mireille Duval didn’t think twice about her decision to raise her hand.
“For me it’s a family thing. My parents both worked in public health … so I’ve been enrolled in college since fourth grade! “
Her desire to make a contribution persisted even after her father passed away in 2008 in order to carry on his legacy. A vaccine study is particularly effective.
Dr. In addition to being a public health specialist, Bernard Duval was among the first to sit on the Quebec Immunization Committee and later served on the National Advisory Committee on Immunization (NACI).
When his daughter received one of the many mailings she receives regularly about medical studies in her area, she said, “It seemed like an opportunity to maybe get the vaccine sooner and also to help with research.”
Like all participants, the 33-year-old volunteer does not know whether she was injected with the vaccine candidate or a placebo, but said she was “very susceptible to the placebo effect and I feel kind of lightheaded”.
Duval will be back for her second “dose” in 21 days, though she said she may be eligible for an approved vaccine by then or a few weeks later.
She said the risk is worth it because she works from home and is generally wary of COVID-19.
“I saw firsthand that it can be difficult to attract participants” and to keep her when she participated in a ten-year study that had many dropouts.
Those who persevered and gave their time were valued, she said. “It feels like I’m not trying too hard” to contribute to science.
MEET THE NEED FOR VACCINE
Several of Medicago’s Phase 3 trials began in Ontario before they began in Quebec, with some participants already receiving the two doses of their assigned product.
Joseph Puopolo of Cambridge, Ontario told CTV in an interview that he signed up before being eligible for a vaccine in his province and stated that the Medicago trial “had a 50-50 shot” . [of getting the vaccine product] but a 100 percent chance that I won’t get anything if I don’t register. “
While his wife works on the front lines as an anesthetist, Puopolo says he is well aware of the ravages of COVID-19 and said one reason he chose to attend is because “it helps to advance science , but there will also be such a need beyond that ”. the globally approved vaccines. “
The 42-year-old marathon runner received his second dose in mid-April two days before his birthday, which was a “wonderful gift,” and believes he got the vaccine rather than the placebo because his weeks of fatigue curled up on his running schedule.
Puopolo has set up a Facebook group, the Medicago Phase 3 Study Group, so that participants can share stories.
Nancy Kreiner of Barrie, Ontario also believes she got the right thing because “after both shots, my arm was swollen and sore for 2 days,” she told CTV in an email, along with the mild fever and pain in the limbs she had after the second injection.
The 46-year-old has never participated in a clinical trial, but Kreiner says she is “proud to be a volunteer for this trial. I believe it is my way of helping society get out of this pandemic, ”and she credits the study design for helping her decide to participate.
WILL I FINALLY GET AN APPROVED VACCINE?
There is a system in place to ensure that volunteers do not indefinitely go without an approved vaccine.
“It would probably be possible to start the so-called crossover phase within a few months,” said Dr. Libman.
This means that anyone who participated in the study will be asked to return to the vaccine center for more vaccinations.
“If you get the vaccine on the first visit, you get a placebo on the second visit. If they got the placebo on the first visit, they would get the vaccine on the second visit, but they wouldn’t know which one to get and when, ”explained Libman.
This offer will only be made if the Medicago vaccine is granted emergency approval in either Canada or any of the countries where it is being tested, including the United States.
The Medicago vaccine developed in Quebec uses a unique plant-based platform with technology that transfers a genetic code to a plant that is part of the tobacco family.
The company says Coronavirus Virus-Like Particles (CoVLP) mimick the virus to boost an immune response without introducing any form of the actual virus into the human body.
The plant then produces the antigen that stimulates the immune response as if it were its own.
Medicago’s approval process was recently accelerated by Health Canada. This means that the agency will review the data as it is submitted, just as it did with the other vaccines that are now approved.
Phase 2 results are expected to be released in May, the company told CTV News, describing the interim results as “positive” in an earlier statement.
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