'Altruistic' Montrealers needed for trial on Medicago’s Quebec-developed COVID-19 vaccine
MONTREAL -- The finish line is finally in sight for the Montreal researchers running the clinical trials on Medicago’s COVID-19 vaccine candidate, with the last phase of testing set to begin at a centre in the West Island next week.
All the Montreal team needs now to proceed with Phase 3 are 50 people to volunteer to get a jab. Recruiting participants will be no small task.
How do you appeal to someone to sign up for a blinded study, which means people won’t know if the syringe will contain the Medicago vaccine candidate or a placebo?
That dilemma is compounded by the fact that the volunteer in question may soon become eligible for an approved vaccine, as Quebec’s rollout picks up steam.
The answer is, they “are asking for a degree of altruism,” said the director of the MUHC Vaccine Study Centre.
“In this case, we are saying that although no one is going to force you to do anything at any time, we are asking people to think about it, and be ready to possibly be vaccinated a little later than they might otherwise be if they weren't in the study,” said Dr. Michael Libman.
The person’s ability to exercise free will “is an essential thing and one of the reasons why we don’t pay people,” said Libman, “because we don’t want there to be any element of coercion here.”
They won’t be too fickle about who comes forward, Libman said with a smile. “We’re looking for anybody who hasn’t been vaccinated!”
The caveat is there are certain health restrictions. Some individuals with underlying illnesses, for example, could be ineligible.
Anyone interested in participating in the development of a new Medicago vaccine is invited to call coordinators at, 514-624-7855. Or, email Giuliana Alfonso at email@example.com
“We’ll answer all of your questions. We’re very eager to speak with you...and you can make your own decision,” said Libman.
CONTINUING HER FATHER’S PUBLIC HEALTH LEGACY
While the Montreal arm of the Medicago trial gets underway next week, some in Quebec City got their first shot on Monday.
Resident Mireille Duval didn’t think twice about her decision to put up her hand.
“It’s a family thing for me. Both my parents were working in public health... so I’ve been enrolled in studies since fourth grade!”
Her desire to contribute continued even after her father died in 2008, a way to carry on his legacy. A vaccine trial, in particular, hits home.
Not only was Dr. Bernard Duval a public health specialist, but he was also among the first to sit on Quebec’s Immunization Committee and later, was a member of the National Advisory Committee on Immunization (NACI).
So when his daughter received one of many mailings she gets regularly about medical studies in her area, she said “it seemed like an opportunity to get the vaccine maybe earlier and also help with research.”
Like all participants, the 33-year-old volunteer doesn’t know if she was injected with the vaccine candidate or a placebo but said she’s “very susceptible to the placebo effect and so I feel kind of woozy.”
Duval will go back for her second ‘dose’ in 21 days, even though she said she might be eligible for an approved vaccine by then or a few weeks later.
She said the gamble is worthwhile because she works from home and is generally careful about exposure to COVID-19.
“I’ve seen first-hand that it can be difficult to recruit participants,” and also to retain them, back when she participated in a ten-year study that had plenty of drop-outs.
The ones who stuck it out and dedicated their time were appreciated, she said. “It feels like not much effort on my part, for the rewards,” of being able to contribute to science.
FEEDING THE NEED FOR VACCINES
Several of Medicago’s Phase 3 trials began in Ontario, before they began in Quebec, with some participants having already received the two doses of whichever product they were assigned to receive.
Joseph Puopolo in Cambridge, Ontario told CTV in an interview, that he signed up before he was eligible for a vaccine in his province, explaining that with the Medicago trial “there was a 50-50 shot [of getting the vaccine product] but a 100 per cent chance I’d get nothing if I didn’t sign up.”
With his wife working on the front lines as an anesthesiologist, Puopolo says he’s very aware of the ravages of COVID-19 and said one reason he decided to participate was because “it’s helpful to advance science but also there’s going to be such a need beyond the approved vaccines across the world.”
The 42 year old marathon runner received his second dose in mid-April two days before his birthday which was a "wonderful gift," and is convinced he got the vaccine not the placebo because of the crimp his week-long fatigue put in his running schedule.
Puopolo has started a Facebook group, 'Medicago- Phase 3 Study Group' so that participants can swap stories.
Nancy Kreiner from Barrie, Ontario is also convinced she got the real deal, because “after both shots my arm was swollen and sore for 2 days afterwards,” she told CTV in an email, as well as the mild fever and body aches she experienced after the second injection.
The 46 year-old has never participated in a clinical trial before but Kreiner says she feels “proud to be a volunteer for this trial. I feel it is my way of helping society dig out of this pandemic,” and she credits the trial design with helping her decide to participate.
WILL I GET AN APPROVED VACCINE EVENTUALLY?
There is a system in place to ensure that volunteers won’t go without an approved vaccine indefinitely.
“Probably within a couple of months there would be the ability to start what we call the crossover phase,” said Dr. Libman.
What that means is that everyone who was part of the study will be asked to return to the vaccine centre to get more shots.
“If they got the vaccine on the first visit then they would 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 they got when,” explained Libman.
This offer will only be made if and when the Medicago vaccine gets emergency approval, either in Canada or in any of the countries where it’s being tested, including in the United States.
The Medicago vaccine, developed in Quebec, uses a unique plant-based platform involving technology that transfers a genetic code to a plant that's a member of the tobacco family.
The company says "Coronavirus Virus-Like Particles" (CoVLP) mimic the virus to encourage an immune response without introducing any form of the actual virus to the human body.
The plant will then produce the antigen that spurs on the immune response as if it was its own.
Medicago’s approval process was recently accelerated by Health Canada. That means the agency will scrutinize the data as it is submitted, as it’s done for the other now approved vaccines.
The results of Phase 2 are expected to be released in May, the company told CTV News, and described interim results as “positive” in an earlier statement.