A Bivalent Omicron-Containing Booster Vaccine against Covid-19.

2019-nCoV Vaccine mRNA-1273 / immunology Adult Antibodies, Neutralizing / immunology Antibodies, Viral / immunology COVID-19 / immunology COVID-19 Vaccines / immunology Humans Immunization, Secondary Immunogenicity, Vaccine / immunology SARS-CoV-2 Vaccines, Combined / immunology mRNA Vaccines / immunology

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
06 10 2022
Historique:
pubmed: 17 9 2022
medline: 12 10 2022
entrez: 16 9 2022
Statut: ppublish

Résumé

The safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known. In this ongoing, phase 2-3 study, we compared the 50-μg bivalent vaccine mRNA-1273.214 (25 μg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-μg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-μg) primary series and first booster (50-μg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose. Interim results are presented. Sequential groups of participants received 50 μg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-μg mRNA-1273.214 and 50-μg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster. The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).

Sections du résumé

BACKGROUND
The safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known.
METHODS
In this ongoing, phase 2-3 study, we compared the 50-μg bivalent vaccine mRNA-1273.214 (25 μg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-μg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-μg) primary series and first booster (50-μg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose.
RESULTS
Interim results are presented. Sequential groups of participants received 50 μg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-μg mRNA-1273.214 and 50-μg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster.
CONCLUSIONS
The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).

Identifiants

DOI: 10.1056/NEJMoa2208343 PMID: 36112399 PMC: PMC9511634
pubmed: 36112399
doi: 10.1056/NEJMoa2208343
pmc: PMC9511634
doi:

Substances chimiques

Antibodies, Neutralizing 0
Antibodies, Viral 0
COVID-19 Vaccines 0
Vaccines, Combined 0
mRNA Vaccines 0
mRNA-1273.214 COVID-19 vaccine 0
2019-nCoV Vaccine mRNA-1273 EPK39PL4R4

Banques de données

ClinicalTrials.gov
['NCT04927065']

Types de publication

Clinical Trial, Phase II Clinical Trial, Phase III Comparative Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1279-1291

Informations de copyright

Copyright © 2022 Massachusetts Medical Society.

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Auteurs

Spyros Chalkias (S)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Charles Harper (C)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Keith Vrbicky (K)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Stephen R Walsh (SR)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Brandon Essink (B)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Adam Brosz (A)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Nichole McGhee (N)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Joanne E Tomassini (JE)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Xing Chen (X)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
ORCID: 0000-0002-6740-9535

Ying Chang (Y)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Andrea Sutherland (A)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

David C Montefiori (DC)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Bethany Girard (B)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Darin K Edwards (DK)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Jing Feng (J)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Honghong Zhou (H)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Lindsey R Baden (LR)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Jacqueline M Miller (JM)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

Rituparna Das (R)

From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).

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Classifications MeSH

questionsmedicales.fr › Facteurs biologiques › Antigènes › Vaccins synthétiques › Vaccins à base d'acide nucléique › Vaccins à ARNm › Vaccin ARNm-1273 contre la COVID-19 › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps neutralisants › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps antiviraux › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antiviraux › Vaccins contre la COVID-19 › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Techniques d'investigation › Techniques immunologiques › Rappel de vaccin › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Phénomènes du système immunitaire › Immunogénicité des vaccins › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Virus › Virus à ARN › Virus à ARN à brin positif › Nidovirales › Coronaviridae › Coronavirus › Betacoronavirus › Virus du SRAS › SARS-CoV-2 › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins combinés › A Bivalent Omicron-Containing Booster Vaccine...
questionsmedicales.fr › Facteurs biologiques › Antigènes › Vaccins synthétiques › Vaccins à base d'acide nucléique › Vaccins à ARNm › A Bivalent Omicron-Containing Booster Vaccine...