Injecting a vaccine with a pre-filled syringe. © Inserm/Depardieu, Michel
The Phase 3 clinical trial of a COVID-19 vaccine is to be launched via Covireivac, a platform set up under the auspices of Inserm and the university hospitals to centralize COVID-19 vaccine trials in France. Janssen, the pharmaceutical division of the Johnson & Johnson group, has obtained the authorizations needed for ENSEMBLE 2, a trial evaluating the efficacy and safety of vaccine candidate Ad26.COV2.S in the prevention of COVID-19 in adults. In France, 1175 volunteers out of those registered on Covireivac will enroll in this clinical trial that will be conducted in 30,000 people across the world.
To conduct the French component of the trial, eight centers have been selected to enroll the 1175 volunteers, representing around 147 per center. The frequency of the disease will be compared between those having received the vaccine and those having received placebo. The aim is to determine whether the administration of two doses of the study vaccine is effective against COVID-19 and whether the vaccine protects against SARS-CoV-2 infection and disease.
The candidate developed by Janssen is based on an attenuated version of a virus that causes rhinopharyngitis in humans (adenovirus) in order to:
This “non-replicating viral vector” vaccine is based on technology used in one of the Ebola vaccines, a product approved by the European Medicines Agency. It will be administered in the form of two intramuscular injections, with the second to be given 57 days (8 weeks) after the first. Details of the trial protocol are published on ClinicalTrials, a database of clinical studies conducted around the world.
The volunteers registered on Covireivac who have been selected to participate in this trial have already been contacted or will be shortly. To be eligible, the volunteers must, for example:
Ineligible for the trial are, for example, volunteers:
“Once a vaccine becomes available in France, it is legitimate that volunteers ask themselves whether they wish to participate in a trial in which some of them will receive placebo. For obvious ethical reasons, for those who will soon be able to access the national vaccination campaign, the answer is that these eventualities will be taken into account in the upcoming protocol amendments and that the option will be there to get vaccinated as part of that campaign should they so wish, even if they have already been enrolled in the trial.” declares Odile Launay, Scientific Manager of Covireivac, whose coordination team is based at Hôtel-Dieu Hospital – AP-HP.
At the request of MSS and MESRI, Inserm has, in coordination with the hospitals and general practitioners, been tasked with setting up infrastructure to conduct clinical trials on COVID-19 vaccines in France. Driven by Inserm, this platform, named Covireivac, federates 24 clinical investigation centers (CICs) located in university hospitals across France, in close collaboration with the College of teachers in general practice. The clinical operational aspects of the various university hospitals are coordinated by the Paris hospital group AP-HP.
Covireivac is based on I-REIVAC, the existing national network for clinical investigation in vaccinology, which has been reinforced and extended for the occasion. This network has been labeled a network of excellence by F-Crin (France’s national clinical research infrastructure). The platform’s infrastructure is funded by MSS and MESRI.
 From France’s drugs regulator (ANSM) and the Île-de-France institutional review board (CPP)
 2 centers in the Île-de-France region (Cochin Hospital AP-HP and Saint Antoine Hospital AP-HP); 3 in Occitanie, 1 in Nouvelle Aquitaine, 1 in Auvergne Rhône Alpes and 1 in Grand Est.
Teams of researchers published on October 4, 2021 in the journal Molecular Psychiatry (Nature Publishing Group) a summary of the results of the international literature on the central role....