The Quebec-based company Medicago has launched Monday its “clinical trials phase 1” in the laboratories of the rue Einstein Syneos Health.
13 July 2020
Updated on July 14, 2020 at 8h17
Vaccine candidate Medicago against the COVID-19: trials on humans started in Quebec city
Its candidate vaccine against the COVID-19 has been carried out in Quebec, and it is also here that he began to be tested on humans : the Quebec-based company Medicago has launched Monday its “clinical trials phase 1” in the laboratories of the rue Einstein Syneos Health, a company that specializes in clinical trials. But what does that mean, exactly? What good is it? That will receive the participants? The Sun spoke with the director of scientific affairs and medical Médicago, Nathalie Charland, in order to see more clearly.
The Sun: The phase 1 trials are used in general and especially to verify the safety of a drug or a vaccine, even if there may be data on effectiveness that are collected at the same time. This is the case even here?
Nathalie Charland: Yes, it is, except that this is not the effectiveness of the vaccine itself that we are going to look at, but rather the immunogenicity : they will determine, for example, the level of antibodies that the body produces after receiving the vaccine. We can not say, however, that such a high level of antibodies is equivalent to be immunized, even if the production of the antibody will be seen as a step in the right direction.
We are also going to test different vaccine formulations, that is to say, different combinations of dose and adjuvants (substances that stimulate the immune response and generally increase the effectiveness of vaccines).
LS: Specifically, how it’s going to happen to the participants? They will receive how many doses of vaccine? Will they be followed for several weeks?
NC: We will start by taking a blood test, in order to have a “starting point” that will allow to measure the effect of the vaccine. Each participant will then receive either a placebo or one of the formulations of the vaccine, and it will happen in two doses : a first dose at from Monday, and then a second at the end of 21 days.
And all the time, we measure the safety of the vaccine candidate. When you inject something, it is sure that there may be local reactions such as redness or a small bump. Some participants may make a little bit of fever also, these are mild side effects are expected. The track will then extend up to 6 months, which is a normal tracking for a candidate vaccine to see if there would be side effects time.
LS: You are aiming for 180 volunteers in this clinical trial. Have you had the misery to recruit?
NC: No, we had no difficulty. In fact, I can tell you that from the 12th of march, when we announced that we had a vaccine candidate, we received calls from people who wanted to test it, then we do not expect to have problems of recruitment.
LS: Medicago expects to be able to produce 100 million doses of vaccine by the end of 2021. Is this a “best case scenario” or a forecast on the conservative?
NC: In fact, it wants to begin the production of the vaccine during the clinical trials phase 2 and 3, which are used to measure the effectiveness, that are predicted this fall. We would launch the production in the hope that the results will prove its effectiveness and allow for a market in the first half of 2021. Because to produce 100 million doses, it takes time.
Already, there has been a lot to accelerate the process for arriving at it. Last march, we were talking about finishing the phase 3 trials by the end of 2021, and we’re talking about the end of 2020. It has been done in three or four months, which usually takes five to six years.