A team of French researchers is on the verge of launching the first clinical trials on their vaccine. This work should give quite a boost to the fight against the sars coronavirus. Christophe d Enfert, scientific director of the Pasteur Institute, the origin of this project, returns to The Point about this tremendous breakthrough.
The Point : Where is the project of vaccine MV-Sars-CoV-2, to develop your teams ?
Christophe d Enfert is the scientific director of the Pasteur Institute. © François Gardy Christophe d Enfert : The tests on the animals that we have made throughout the spring we have an opportunity to select a candidate vaccine for which we know that it allows the production of neutralizing antibodies able to block the Sars-CoV-2 in vitro. We are preparing for the test, course of July, about 90 volunteers in France and Belgium. This first clinical phase will allow time to evaluate its safety on the human being and its ability to induce an immune response.
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is it the project of vaccine that we were talking about in your latest interview to the Point ?
Yes. We use an attenuated strain of measles virus, which is normally used for the vaccination against measles, and in which the genetic material has been modified so that it produces the Spike protein that allows the coronavirus to enter our cells.
An ancient technique ?
Not so old as that, since it dates back to the early 2000s. But a promising technique, because it allowed us to develop several vaccines, the last of which, against the chikungunya virus, is currently in phase 3 (the last step before commercialization). It is also through the use of this recombinant virus that we have been able to develop vaccines against other diseases such as Zika, Sars or Lassa fever...
It is not, therefore, of the traditional technique, which is to use a version that is inactivated pathogen...
No. The method that you mention is a method that has notably helped develop the first polio vaccines. Other methods have been developed since that time : that of the recombinant viruses, which I come to speak to you, and another that uses the injection of nucleic acids (DNA, RNA) and allows to transmit to the cells at the site of injection, and instructions to fabricate, for example, the Spike protein resulting in the immune response against the coronavirus.
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To return to your project of a vaccine MV-Sars-CoV-2 if it is in phase 1 during the course of July, when will he be marketed ?
At this point, I prefer to stay cautious. Let's say the first half of 2021.
It is earlier than what was expected, no ?
Indeed. We went faster than we had hoped on the first steps. All the procedures have been expedited, but there is still a long way to go. And the road is strewn with obstacles. Our vaccine candidate meets all the criteria for a clinical batch can be tested on humans. This phase-1 will examine if its formula is well-tolerated, if it does not cause side effects. It will also help us to determine what doses are most adapted to produce antibodies and immune cells targeting the Sars-CoV-2. Based on the results obtained, we will then phases 2 and 3.
what is it ?
phase 2 will check to see if the formula of this vaccine induces a protective immune response. And phase 3 if it protects well against infection. These two phases can be combined to save time. They will be under the responsibility of our partners, Themis, and MSD, and could begin in October. The first results of phase 3 could be obtained by march 2021. But we may be exposed, at that time, to a problem.
Which one ?
The decrease in the number of people affected by the virus. If we want to be able to compare the relative effect of the vaccine in the face of the pathogen, the pool of people exposed to the virus must be relatively important.
This is the reason for some laboratories to test their vaccine in Brazil, where the epidemic continues to soar ?
Yes. Others, such as the Jenner Institute at Oxford university and the biopharmaceutical group AstraZeneca, turn, for their part, to South Africa.
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what support do you receive ?
Since the company Themis Bioscience, with whom we have signed a partnership agreement in 2012 on the platform of the measles vaccine, has been acquired by the group and MSD in may of last year, this project of vaccine has the support of the 4th largest pharmaceutical group worldwide. It is he who will take in charge the organization of the phases 2 and 3 in connection with the university of Pittsburgh, in the United States. This partnership is fundamental. We are a research foundation non-profit. Our job is not commercialization of health products. The group MSD has, moreover, given the assurance that the price of the vaccine would ensure access to all. We are very attached to this idea that access to the vaccine is equitable and not reserved only for developed countries.
Your institute also has a grant from the Coalition for innovations in the field of epidemic preparedness (CEPI), created in 2017, in particular by the Bill Gates foundation .
The CEPI has paid 4.5 million euros to finance the first phases of development of the vaccine.
Why don't you have to be associated to the Sanofi group that maintains close links with your home ?
Our links are close on other projects, but not on this one.
Are you in the process of catch up on projects, chinese, american, and british ?
We move at our own pace. There will probably not be a single vaccine against the Sars-CoV-2. We know. The idea is not to be the 30th to arrive on the market, but in the first five. The path that we follow is clear. And the processes that we use are reliable. Others have taken the lead in embarking on the adventure of a vaccine-RNA,as the american group Moderna. It's a way to bold, but we don't know if it will be successful, or how its industrial deployment on a large scale can be done.
do you Have other projects of a vaccine against the Covid-19 ?
of course. We are exploring a number of parallel technologies. One of them uses a lentiviral vector-type HIV. The first results are very encouraging. We are developing this project with the start-up Theravectis, a result of the Institute. We speculate on the possibility of launching clinical trials.
This could be arranged during the summer.
other teams are they working on vaccines against the Sars-CoV-2 ?
Yes. We are testing a project of DNA immunization to production of the Spike protein by the cells at the injection site resulting in the immune response. Here, too, the first results are very satisfactory. We have the same thinking as for the vaccine lentiviral vector. Four other projects will explore ways to optimize vaccine antigens or the use of other vectors. One of our goals is to allow a cellular response cytotoxic (or killer cells attack the pathogen).
in The United States comes now the question of the challenges to be infectious (or Human Challenge Trial), which consists, after having them immunized, to infect voluntarily of patients with a virus. The Institut Pasteur is ready to embark on this type of experimentation ?
At this point, the answer is clearly no. At least in respect of the Sars-CoV-2. The Covid-19 is too dangerous for that we were exhibiting volunteers, even if they are young and in good health. We know that associations encourage this type of testing and that the world health Organization (WHO) thinks of it. But given the lack of effective treatment for the coronavirus, we do not want to take that risk. This is not a position of principle, because this method can, indeed, be very interesting in other contexts. For some conditions, we have done it. We will soon be starting a "challenge" infectious " against shigellosis : a bacterial dysentery potentially fatal for children. We will do this in partnership with the university of Maryland in the United States in a very medicalised. We do not present to that of adults by the bacillus shigella. And we will because we know that this disease is not fatal for adults and can be treated by antibiotic. So the risk is minimal. This is not the case with the Covid-19.
Updated Date: 26 June 2020, 08:33