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Covid-19 booster doses: start of inclusions in the COVIBOOST trial

Press release | 08 Dec 2021 - 15h00 | By INSERM PRESS OFFICE
Covid-19

Vaccin Anti Covid

French health authorities recommend that all adults over 18 years of age perform a booster injection with a MRNA to ensure maximum and prolonged vaccine protection.© AdobeStock

 

In a context of winter circulation of the virus, a constant increase in the number of confirmed cases and the appearance of new variants, the French health authorities recommend that all adults over 18 years of age perform a booster injection with a MRNA to ensure maximum and prolonged vaccine protection.

Administration of a 3 rd dose of a different vaccine could nevertheless have advantages in terms of efficacy and safety, but also in terms of cost and acceptability.

The COVIBOOST trial is designed to study the immune response of the two candidates based recombinant protein vaccine associated with an adjuvant developed by Sanofi Pasteur and GSK and that of a 3 rd dose of the Pfizer-Biontech vaccine.

This randomized double-blind trial, promoted by Assistance Publique – Hôpitaux de Paris, will be carried out in 11 hospitals in the COVIREIVAC network coordinated by Inserm. It starts on December 8.

300 participants who had previously received two doses of the Pfizer-BioNTech vaccine ( 2nd dose received within 5 to 7 months) and without a history of Covid-19 will be included, half of them aged 65 and over.

They will randomly receive a booster dose:

– the mRNA vaccine from Pfizer-BioNTech (Comirnaty®)

– the adjuvanted recombinant protein vaccine from Sanofi-Pasteur / GSK based on the original strain of the virus (Wuhan strain)

– the adjuvanted recombinant protein vaccine from Sanofi-Pasteur / GSK based on the beta variant (South African variant)

The data from the trial will make it possible to measure the immune response induced by the three vaccines studied as a booster, and its effectiveness on the different variants but also its persistence at 3 and 12 months, depending on age.

This is the eighth study launched by COVIREIVAC.

The booster vaccination as part of the trial will validate the health pass for the 3rd dose according to national requirements.

Today the booster dose with an mRNA vaccine has become essential. But we hope to broaden the range of possibilities with other vaccine technologies. » Explains Marie Lachâtre, infectious disease doctor (Hôpital Cochin and Hôtel Dieu / APHP) and member of COVIREIVAC. “The Sanofi-Pasteur / GSK vaccine candidates have for several months been the subject of phase 3 clinical trials as a primary vaccination or as a booster. Today we want to assess the immune response they induce by booster compared to that of the Pfizer-BioNTech vaccine ”.

This clinical study has been labeled a “national research priority” on Covid-19 by the Ministry of Health and Solidarity.

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.

Even if several vaccines against Covid-19 are available, it is imperative to continue research in order to deepen scientific knowledge, in particular the duration of protection and the quality of the immune response.

The objective of the clinical studies coordinated by COVIREIVAC is to provide answers to these research questions.  

TO CITE THIS POST :
Press release – Inserm press room Covid-19 booster doses: start of inclusions in the COVIBOOST trial Link : https://presse.inserm.fr/en/covid-19-booster-doses-start-of-inclusions-in-the-coviboost-trial/44358/
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