The vaccine candidate developed by Janssen, a pharmaceutical division of the American group Johnson & Johnson, will soon be the subject of a phase 3 clinical trial in France.
“Set 2”
In its press release, Inserm announces the imminent launch of a vaccine clinical trial via its Covireivac platform. The Janssen laboratory has in fact received authorization for this project called “Ensemble 2”. The aim is to assess the efficacy and safety of the Ad26.COV2.S vaccine in eight French centers. The study will include 1,175 participants, for a distribution of 150 volunteers per center. Globally, 30,000 people will be involved in this study. The results will determine the safety of the vaccine if it is administered in two doses and its protective effect on Covid-19. The vaccine manufactured by Janssen (Belgium) is based on a technology which has already proved its worth against Ebola: it is ” an attenuated version of a virus that causes nasopharyngitis in humans “. The adenovirus will then reveal part of the Sars-Cov-2 virus, and particularly the Spike or S protein, which will be recognized by the immune system. Thus, the body will be able to create antibodies against the new coronavirus and prevent it from replicating in cells. Two injections will be necessary, the second of which should be administered 57 days, or 8 weeks, after the first.
Janssen vaccine, how effective?
According to the Johnson & Johnson laboratory, the vaccine is 66% effective against Covid-19. In addition, Inserm declares in its press briefing that “ the first available results show that the vaccine candidate is well tolerated and induces the production of neutralizing antibodies against SARS-CoV-2 in more than 90% of participants 29 days after vaccination and in nearly 100% of them after 57 days “. Also, two doses strengthen immunity, thanks to the multiplication by 2 to 3 of the quantity of antibodies. To participate in the study, volunteers registered on the Covireivac platform were chosen according to the eligibility conditions: being of legal age, in good health and being affiliated to a social security system. Free and informed consent is also required. Pregnant women cannot participate in the clinical trial. It is essential to ” continue the trials in order to deepen scientific knowledge, in particular on the duration of protection and the quality of the immune response », Concludes Inserm.
