Evidence map›Paper›PMID 35582124›Full record

ArticleEClinicalMedicine2022

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

Cécile Janssen, Marine Cachanado, Laetitia Ninove, Marie Lachatre, Jocelyn Michon, Olivier Epaulard, Zoha Maakaroun-Vermesse, Christian Chidiac, Bruno Laviolle, Hugues Aumaitre and 18 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04900467 (Multicenter, Randomized, Open-label Trial Comparing the Immunological Efficacy of a Vaccine Regimen Combining Two Covid19 mRNA Vaccines), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04900467 naunknown statusnot on this map

Multicenter, Randomized, Open-label Trial Comparing the Immunological Efficacy of a Vaccine Regimen Combining Two Covid19 mRNA Vaccines (Pfizer-BioNTech and Moderna) With That of a Homologous Vaccination of Each Covid19 mRNA Vaccine: Non-inferiority Trial

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2021 to 2022Enrolled418ConditionsAdult Who Received a First Dose of an mRNA Vaccine (Pfizer-BioNTech or Moderna) and Need to Receive a Second DoseArmsPfizer, Moderna
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Heterologous prime boost COVID 19 vaccination.Infectious diseases now · 2022
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 8 institutions in 1 country.

Cécile JanssenService de Maladies Infectieuses, Centre Hospitalier Annecy Genevois, Annecy 74370, France.
Marine CachanadoAssistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (Unité de Recherche Clinique (URCEST), Centre de Recherche Clinique (CRCEST), Centre de Ressources Biologiques (CRB.APHP-SU), Paris, France.
Laetitia NinoveUnité des Virus Emergents, UVE: Aix Marseille Univ, IRD 190, INSERM 1207, Marseille 13005, France.
Marie LachatreCentre d'Investigations Cliniques (CIC 1417) Cochin Pasteur, AP-HP, Hôpital Cochin, Paris, France.
Jocelyn MichonInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Olivier EpaulardInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Zoha Maakaroun-VermesseInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Christian ChidiacInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Bruno LaviolleInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Hugues AumaitreSMIT Perpignan - Infectious and Tropical Disease Unit, Perpignan Hospital Center, Perpignan, France.
Ady AssafInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Karine LacombeInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Catherine Schmidt-MutterInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Elisabeth Botelho-NeversInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Magali BriereMaison de la Médecine Préventive, Service de Médecine interne, Maladies Infectieuses, hématologie, Centre Hospitalier Bretagne Atlantique, 20, boulevard Maurice Guillaudot, Vannes 56000, France.
Thomas BoissonService de Médecine Interne, Centre Hospitalier Alpes Léman, Contamine Sur Arve, France.
Paul LoubetInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Boris BienvenuInserm, F-CRIN, I REIVAC/COVIREIVAC, France.
Olivier BouchaudAP-HP, Service des Maladies Infectieuses et Tropicales, Hôpital Avicenne, Université Paris-13, Bobigny, France.
Amel TouatiAssistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (Unité de Recherche Clinique (URCEST), Centre de Recherche Clinique (CRCEST), Centre de Ressources Biologiques (CRB.APHP-SU), Paris, France.
Christine PereiraCentre d'Investigations Cliniques (CIC 1417) Cochin Pasteur, AP-HP, Hôpital Cochin, Paris, France.
Alexandra RousseauAssistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (Unité de Recherche Clinique (URCEST), Centre de Recherche Clinique (CRCEST), Centre de Ressources Biologiques (CRB.APHP-SU), Paris, France.
Laurence BerardAssistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (Unité de Recherche Clinique (URCEST), Centre de Recherche Clinique (CRCEST), Centre de Ressources Biologiques (CRB.APHP-SU), Paris, France.
Melissa MontilAssistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (Unité de Recherche Clinique (URCEST), Centre de Recherche Clinique (CRCEST), Centre de Ressources Biologiques (CRB.APHP-SU), Paris, France.
Xavier de LamballerieUnité des Virus Emergents, UVE: Aix Marseille Univ, IRD 190, INSERM 1207, Marseille 13005, France.
Tabassome SimonAssistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (Unité de Recherche Clinique (URCEST), Centre de Recherche Clinique (CRCEST), Centre de Ressources Biologiques (CRB.APHP-SU), Paris, France.
Odile LaunayCentre d'Investigations Cliniques (CIC 1417) Cochin Pasteur, AP-HP, Hôpital Cochin, Paris, France.
ARNCOMBI Study Group
Inserm · FRSorbonne Université · FRUniversité Claude Bernard Lyon 1 · FRCentre hospitalier Bretagne Atlantique · FRCentre Hospitalier de Perpignan · FRCentre Hospitalier René-Dubos · FRCentre National de la Recherche Scientifique · FRUniversité Sorbonne Paris Nord · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 ( 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.

Identifiers

PMID35582124
PMCPMC9098199
OpenAlexW4280524065

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.