Title :

Immunogenicity and reactogenicity of heterologous and homologous mRNA-1273 and BNT162b2 vaccination: A multicenter non-inferiority randomized trial

Author(s) :

Janssen, Cécile [Auteur]
Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
Cachanado, Marine [Auteur]
CHU Saint-Antoine [AP-HP]
Ninove, Laetitia [Auteur]
Unité des Virus Emergents [UVE]
Lachatre, Marie [Auteur]
CIC Cochin Pasteur [CIC 1417]
Michon, Jocelyn [Auteur]
CHU Caen
Epaulard, Olivier [Auteur]
Centre d'Investigation Clinique [Grenoble] [CIC Grenoble]
Maakaroun-Vermesse, Zoha [Auteur]
Centre d’Investigation Clinique [Tours] CIC 1415 [CIC ]
Chidiac, Christian [Auteur]
Laviolle, Bruno [Auteur]
CHU Pontchaillou [Rennes]
Institut de recherche en santé, environnement et travail [Irset]
Centre d'Investigation Clinique [Rennes] [CIC]
Aumaitre, Hugues [Auteur]
Centre Hospitalier Saint Jean de Perpignan
Assaf, Ady [Auteur]
Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 [CIIL]
Lacombe, Karine [Auteur]
Institut Pierre Louis d'Epidémiologie et de Santé Publique [iPLESP]
Schmidt-Mutter, Catherine [Auteur]
CIC Strasbourg [Centre d’Investigation Clinique Plurithématique (CIC - P) ]
Botelho-Nevers, Elisabeth [Auteur]
Briere, Magali [Auteur]
Centre hospitalier Bretagne Atlantique (Morbihan) [CHBA]
Boisson, Thomas [Auteur]
Loubet, Paul [Auteur]
Virulence Bactérienne et Infections Chroniques [VBIC]
Bienvenu, Boris [Auteur]
Hôpital Saint-Joseph [Marseille]
Bouchaud, Olivier [Auteur]
Hôpital Avicenne [AP-HP]
Touati, Amel [Auteur]
CHU Saint-Antoine [AP-HP]
Pereira, Christine [Auteur]
CIC Cochin Pasteur [CIC 1417]
Rousseau, Alexandra [Auteur]
CHU Saint-Antoine [AP-HP]
Berard, Laurence [Auteur]
CHU Saint-Antoine [AP-HP]
Montil, Melissa [Auteur]
CHU Saint-Antoine [AP-HP]
de Lamballerie, Xavier [Auteur]
Unité des Virus Emergents [UVE]
Simon, Tabassome [Auteur]
CHU Saint-Antoine [AP-HP]
Launay, Odile [Auteur correspondant]
F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC)
CIC Cochin Pasteur [CIC 1417]

Journal title :

EClinicalMedicine

Pages :

101444

Publisher :

Elsevier

Publication date :

2022-06

ISSN :

2589-5370

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

BACKGROUND: Although effective mRNA vaccines for SARS-CoV-2 infection have been deployed worldwide, their interchangeability could facilitate the scale-up of vaccination programs. The objective of the trial was to assess ...
Show more >BACKGROUND: Although effective mRNA vaccines for SARS-CoV-2 infection have been deployed worldwide, their interchangeability could facilitate the scale-up of vaccination programs. The objective of the trial was to assess whether the immune response induced by a heterologous SARS-CoV-2 mRNA primo vaccination is non-inferior to that of a homologous mRNA vaccination. METHODS: We conducted a multicenter, randomized, open-label trial in adults 18 years of age and older who received a first dose of SARS-CoV-2 mRNA vaccine. Participants were randomly assigned in a 1:1 ratio to receive a second dose of BNT162b2 or mRNA-1273, 28 to 49 days after the first dose. Randomization was stratified on the vaccine received at the first vaccination. The primary endpoint was the anti-spike IgG antibodies titer measured 28 days after the second vaccine dose. This study is registered with ClinicalTrials.gov, Trial, NCT04900467. FINDINGS: Of the 414 randomized participants recruited from May 28 to July 2, 2021, 390 were included in the per protocol analysis: 94 participants in group 1 (BNT162b2/BNT162b2), 96 in group 2 (BNT162b2/mRNA-1273), 97 in group 3 (mRNA-1273/mRNA-1273), and 103 in group 4 (mRNA-1273/BNT162b2). The geometric mean titers ratios of anti-spike IgG antibodies for each heterologous regimen relative to the corresponding homologous regimen were 1·37 (two-sided 95% CI, 1·10 to 1·72) in the groups 1 and 2 and 0·67 (two-sided 95% CI, 0·55 to 0·82) in the groups 3 and 4. Levels of neutralizing antibodies to the main circulating SARS-Cov-2 viral strains were higher with the vaccine regimen containing mRNA-1273. Participants who received mRNA-1273 as a second dose experienced a higher rate of local adverse reactions and general symptoms than those who received BNT162b2 (p < 0·0001). INTERPRETATION: The two SARS-CoV-2 mRNA vaccines could be used with flexibility for the second dose of COVID-19 primo vaccination. Tolerance remains good regardless of vaccine sequence although mRNA-1273 was more reactogenic. FUNDING: French Ministries of Solidarity and Health and Research. BNT162b2 was provided by Pfizer/BioNTech. mRNA-1273 was provided by Moderna.Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Centre d'Infection et d'Immunité de Lille (CIIL) - U1019 - UMR 9017

Source :

Harvested from HAL