Covid-19 vaccine injection © AdobeStock
In order to facilitate the organization of the vaccination campaign, it may be proposed to use one or the other of the two mRNA vaccines for the 2nd dose (Pfizer-BioNTech or Moderna) of vaccination . The aim of the AP-HP – ARNCombi trial is to compare the immunological efficacy of the standard vaccine regimen with two doses of the same mRNA vaccine against Covid-19 with a regimen combining two different mRNA vaccines (one dose of Moderna vaccine after one dose of Pfizer vaccine or a dose of Pfizer vaccine after a dose of Moderna vaccine). It is promoted by Assistance Publique – Hôpitaux de Paris and made possible thanks to the COVIREIVAC platform coordinated by Inserm.
400 participants are expected for this randomized trial. Participants must be over 18 years of age, have already received one of two doses of messenger RNA vaccine with a second scheduled injection within 4-6 weeks of the first injection.
A blood sample to test for the presence of specific antibodies directed against the SARS Cov-2 virus (Covid-19 virus) will be taken before the 2nd dose and then four weeks later.
The first inclusions took place on May 28, 2021. The trial is being carried out in 17 centers in France: three AP-HP hospitals and 14 other centers throughout France. Some of these centers are part of the COVIREIVAC platform.
Launched in October 2020, the COVIREIVAC platform coordinated by Inserm and F CRIN in conjunction with 32 university hospitals and a network of 11 immunology laboratories aims to conduct and promote excellent clinical vaccine research in France. Since October 1, 2020, 50,000 volunteers have registered to participate in research efforts and improve knowledge about these new vaccines. This is an unprecedented initiative in our country. The platform is managed by Inserm, and the clinical operational component is coordinated by the Assistance Publique-Hôpitaux de Paris of the various CHUs. New research projects are regularly launched within the framework of COVIREIVAC.
