Currently, two vaccines are already on the market in Europe to fight COVID-19 : the Pfizer / BioNtech vaccine (Comirnaty) and the vaccine from the Moderna laboratory (COVID-19 Vaccine Moderna). But there are many other laboratories hoping to get the green light from health agencies, as was recently the case for the AstraZeneca vaccine approved on January 29 by the European Medicines Agency. Another vaccine could soon come to the rescue of the vaccine campaign in France, that of Janssen, pharmaceutical division of the Johnson & Johnson group, which has just received the necessary authorizations to start a clinical trial, part of which will be conducted in France.
Called “ENSEMBLE 2”, it will assess the effectiveness and safety of this vaccine candidate called “Ad26.COV2.S” for the prevention of Covid-19 in adults. Specifically, this is a phase 3 trial conducted in several countries including France, Germany, Spain and Belgium that is studying the safety and efficacy of a two-dose regimen versus to a placebo with 30,000 participants. “The study will assess the efficacy of the experimental vaccine after the first and second dose to assess the protection against the virus and the potential additional benefits for the duration of protection with a second dose. ”, explains the Johnson & Johnson Group in a recent press release.
In France, the clinical trial will be conducted by Inserm ins the framework of its COVIREIVAC platform and 1175 volunteers will be included. Eight centers were selected (two centers in Île de France, three in Occitanie, one in New Aquitaine, one in Auvergne Rhône Alpes and one in the Grand Est), ie around 150 participants per center. This vaccine candidate is based on an attenuated version of a virus responsible for nasopharyngitis in humans (adenovirus). It works by producing only part of the COVID-19 virus, the spike protein “S”, which will be recognized by the immune system and thus induce an immune response, and by blocking the multiplication of SARS-CoV-2 in the body.
As explained by Inserm, which publishes the details of the protocol on the ClinicalTrials platform, “This vaccine says to “non-replicating viral vector” is based on technology that was used for one of the Ebola vaccines approved by the European Medicines Agency. It is administered intramuscularly to volunteers in two injections, the second being given eight weeks (57 days) after the first. The first results available show that the vaccine candidate is well tolerated and induced production of neutralizing antibodies against SARS-CoV-2 in more than 90% of participants 29 days after vaccination and in almost 100% of them after 57 days after vaccination.
Become a volunteer to test COVID vaccines
Preliminary data have also shown that “the vaccination schedule in two doses (vs a single injection) multiplies by 2 to 3 the quantity antibodies produced against SARS-CoV-2. », Adds Inserm. The volunteers registered on Covireivac who were selected to participate in this study have been contacted or will be contacted shortly. They must be at least 18 years old, in good health or with pre-existing medical conditions in which the condition is stable. Conversely, volunteers with unstable medical conditions, having already been vaccinated against COVID-19 or having received another type of vaccine in the 14 days preceding the vaccination visit cannot be included.
“From the moment a vaccine is available in France, volunteers can legitimately ask themselves if they wish to participate in a trial in which a portion of them would receive a placebo. », Declares Odile Launay, scientific manager of the platform. “For obvious ethical reasons, for those who will soon have access to the vaccination campaign, the answer is that these eventualities will be taken into account in the next amendments to the protocol and that it will be possible for a participant to get vaccinated as part of the national immunization campaign if he wishes even if he was included in the trial. She adds.
Set up on October 1, the COVIREIVAC platform has included 40,000 volunteers since its launch, in particular to conduct studies on Covid-19 vaccines in France. Registrations are always open to people who wish, just pre-register on the covireivac.fr website and complete a health questionnaire. Be careful, however, participation in clinical trials does not guarantee priority access to vaccines placed on the market. It was last December that Inserm announced the start of three vaccine clinical trials in France via COVIREIVAC, subject to the agreement of the regulatory authorities, with manufacturers Astra Zeneca, Janssen and Moderna.
To find out more about the coronavirus, the editorial staff invites you to discover its more complete and regularly updated articles:
- an article on Covid-19 disease and the evolution of the epidemic
- an article on the different screening tests
- an article on vaccines under development.