The big day of testing in the human is finally arrived for the vaccine candidate of the quebec-based company Medicago. The first tests of this phase, the initial clinical began Monday.
The director of scientific affairs and medical of the company, Nathalie Charland, don’t hide it, the day was really good after all of these efforts.
“It’s a very, very beautiful day. It is a first achievement after several weeks of intensive work,” says the head of Medicago.
The work, however, is not complete, assure-t-on.
“This is only the first milestone, but all of these milestones are important because it is what gives us the energy to move to the next step,” says Ms. Charland, recalling that the company “has made in three or four months, which is normally done in five years”.
Thus, they are 180 volunteers who have undertaken yesterday, in Montreal and Quebec city, the phase 1 clinical trials in humans for the vaccine, Medicago’s against the COVID-19.
The objective of this first phase, driven by the company Syneos Health, aims to determine if the vaccine is safe for humans, while collecting preliminary results on the effectiveness of the immune response it produces.
The trial will allow Medicago to test different variants of its vaccine candidate to the following partnerships that have been announced in recent weeks.
The quebec company has agreed with the pharmaceutical GSK and Dynavax for the addition of an adjuvant to the vaccine, which would have the effect of boosting its effect and so help to reduce the necessary dosage.
“People are going to receive either a placebo or the vaccine candidate alone or the vaccine candidate with the one or the other adjuvants,” explains Nathalie Charland, emphasizing the importance of evaluating the range of possibilities.
Other work in parallel
The beginning of this first phase of the test does, however, not the end of the work for Medicago. Since the early beginning of work, on board in parallel to the other two phases of testing are needed before commercialization.
Phase three, in particular, requires a sample of between 10 000 and 20 000 people in a place where the virus is active, which can be a challenge.
“In fact, at this point, I can’t even tell where there will be a phase 3 because it will be in a place where the virus is circulating on a large scale. It takes a certain number of cases. […] And it takes some time to plan,” confirms Nathalie Charland.
“Test of solidarity”
The world Health Organization (WHO) board, however, on “a test of solidarity,” says the Company.
It is a form of phase 3 on a global scale for multiple vaccine candidates simultaneously, which would speed up the process.
“They’re trying to draw this global clinical trial to test several vaccines at the same time. Instead of having different phases 3, there would be a single big phase 3. And Medicago is part of the discussions for it. But nothing is decided for the moment,” explains the scientific director of the biopharmaceutical.
If all goes as planned, the company whose headquarters is located in Quebec city hopes to make its vaccine available in the first half of 2021.
The conduct of the phase 1
- 180 volunteers
- Subjects of 18 to 55 years old
- Doses of 3.75, 7.5 or 15 micrograms of the vaccine candidate
- Will receive over the next few days either a placebo, the vaccine candidate alone or the vaccine candidate with an adjuvant
- After three weeks, a dose of recall will be given
- After the doses, of the blood tests, biochemical tests and other examinations will be performed to analyze the safety of the vaccine and its results
- The phases 2 and 3 could be held from October
- At term, the Company plans to be able to produce 100 million doses by the end of 2021