MONTREAL -- Quebec City-based pharmaceutical developer Medicago has announced it’s ready to move forward with a phase three clinical trial of its COVID-19 vaccine candidate, after seeing “positive” interim results from phase two, the company said on Tuesday.
An adjuvant or ‘booster’ produced by GlaxoSmithKline and administered along with the vaccine will also be studied.
Both the U.S. Food and Drug Administration and Health Canada have approved the enrollment of up to 30,000 healthy adults worldwide, some of them in Montreal.
“It’s exciting on multiple levels,” said Dr. Michael Libman, director of the MUHC Vaccine Study Centre in the West-island, where a phase two trial took place and where they’re preparing for the next leg.
“We always have to look at the silver lining of some of these things. Yes, it’s a pandemic and it’s pretty bad all around,” but among the few good things to come out of it, “is it’s given an enormous kick in the pants to vaccine development,” Libman, an infectious diseases specialist, said in an interview.
Libman explained that many different vaccine technologies have sat on the shelf at research labs around the world for years because scientists couldn’t justify the need for new types of vaccines.
But now with the stakes so high, Libman says “We suddenly have a justification to say let's try and make this work and try six different things at the same time.”
The result is a “fantastic situation,” where several companies can each follow different scientific paths to arrive at the same destination: a safe and effective COVID-19 vaccine.
Libman said he suspects that when the dust settles, they're going to find that these technologies are actually "better than all the technologies we’ve been using until now,” and might even result in vaccines for other illnesses.
MONTREAL RECRUITMENT FOR PHASE THREE
The team at the MUHC Vaccine Study Centre in Pierrefonds is eager to get started on the final stage of the clinical trial but is still waiting to get the green light to begin recruitment.
Libman said recruitment this time around won’t be easy, describing it as a “real conundrum,” because so much is out of their control.
“One of the problems, of course, is that vaccines have become available, and so we’re looking for people who haven’t yet been vaccinated,” something that will soon start becoming more difficult.
Case in point, the investigators want to include some seniors in phase three to establish that the vaccine “works across all age groups.”
But everyday, more and more seniors in the Montreal area are getting their shots. That’s fortunate for the seniors, but creates a challenge for vaccine testers.
The next issue is that the companies need to test their vaccine in countries where the disease is active.
“Nobody’s doing these studies in Australia because nobody has COVID in Australia," said Libman. "You could vaccinate 30,000 people in Australia, it wouldn’t prove anything. Nobody would get sick in either group!”
While many health officials are predicting a third wave, case counts are steady or are dropping ever so slightly in Quebec now - a positive sign for the province overall, but strike two for vaccine testing.
Researchers always depend on volunteers with a certain degree of altruism and that will be especially true in this case, but the design of the phase three trial has also been altered to take today’s vaccine-rollout environment into account.
This time around participants will be told in advance that should they wind up in the placebo group, they will be offered the Medicago vaccine at an appropriate time.
Those interested in volunteering to roll up their sleeve for the Medicago clinical trial eventually, can get more information about the study on the centre’s website.
MEDICAGO VACCINE TECHNOLOGY
Medicago said its vaccine candidate uses "coronavirus virus-like particles" (CoVLP), which mimic the virus to encourage an immune response without introducing any form of the actual virus to the human body.
In order to make its vaccine, Medicago uses technology that transfers a genetic code to a plant that's a member of the tobacco family.
The plant will then produce the antigen that spurs on the immune response as if it was its own.
Two doses of the vaccine candidate, along with the adjuvant, are administered three weeks apart, and the product can be stored in a regular pharmacy-grade refrigerator.
The adjuvant, given in tandem with the vaccine to boost its effect, “is like giving the immune system six cups of coffee, and saying, wake up, this thing you’re seeing (the vaccine) is important,” said Libman.
Results from the phase two part of the clinical trial are expected to be made public in April, according to a company statement.
If successful, a Medicago COVID-19 vaccine would finally give Canada some vaccine independence.
Although the company is no longer majority-Canadian owned, it is headquartered in Quebec City, and received $173 million from Canada’s Strategic Innovation Fund to help with the construction of a manufacturing facility there.
“At least it’s a company with a presence here, with some manufacturing capability here and we would not have to beg other jurisdictions to please let us have some vaccine,” said Libman.
