Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 Coronavirus Efficacy (COVE) Trial.
COVE trial
COVID-19
SARS-CoV-2
immunogenicity
mRNA-1273
pseudovirus neutralizing antibody assay
spike-binding antibody assay
Journal
The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675
Informations de publication
Date de publication:
11 11 2022
11 11 2022
Historique:
received:
07
03
2022
accepted:
06
05
2022
pubmed:
11
5
2022
medline:
15
11
2022
entrez:
10
5
2022
Statut:
ppublish
Résumé
Messenger RNA (mRNA)-1273 vaccine demonstrated 93.2% efficacy against coronavirus disease 2019 (COVID-19) in the Coronavirus Efficacy (COVE) trial. The humoral immunogenicity results are now reported. Participants received 2 mRNA-1273 (100 µg) or placebo injections, 28 days apart. Immune responses were evaluated in a prespecified, randomly selected per-protocol immunogenicity population (n = 272 placebo; n = 1185 mRNA-1273). Serum binding antibodies (bAbs) and neutralizing antibodies (nAbs) to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-spike protein were assessed at days 1, 29, and 57 by baseline SARS-CoV-2-negative (n = 1197) and SARS-CoV-2-positive (n = 260) status, age, and sex. SARS-CoV-2-negative vaccinees had bAb geometric mean AU/mL levels of 35 753 at day 29 that increased to 316 448 at day 57 and nAb inhibitory dilution 50% titers of 55 at day 29 that rose to 1081 at day 57. In SARS-CoV-2-positive vacinees, the first mRNA-1273 injection elicited bAb and nAb levels that were 11-fold (410 049) and 27-fold (1479) higher than in SARS-CoV-2-negative vaccinees, respectively, and were comparable to levels after 2 injections in uninfected participants. Findings were generally consistent by age and sex. mRNA-1273 elicited robust serologic immune responses across age, sex, and SARS-CoV-2 status, consistent with its high COVID-19 efficacy. Higher immune responses in those previously infected support a booster-type effect. Clinical Trials Registration. NCT04470427.
Sections du résumé
BACKGROUND
Messenger RNA (mRNA)-1273 vaccine demonstrated 93.2% efficacy against coronavirus disease 2019 (COVID-19) in the Coronavirus Efficacy (COVE) trial. The humoral immunogenicity results are now reported.
METHODS
Participants received 2 mRNA-1273 (100 µg) or placebo injections, 28 days apart. Immune responses were evaluated in a prespecified, randomly selected per-protocol immunogenicity population (n = 272 placebo; n = 1185 mRNA-1273). Serum binding antibodies (bAbs) and neutralizing antibodies (nAbs) to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-spike protein were assessed at days 1, 29, and 57 by baseline SARS-CoV-2-negative (n = 1197) and SARS-CoV-2-positive (n = 260) status, age, and sex.
RESULTS
SARS-CoV-2-negative vaccinees had bAb geometric mean AU/mL levels of 35 753 at day 29 that increased to 316 448 at day 57 and nAb inhibitory dilution 50% titers of 55 at day 29 that rose to 1081 at day 57. In SARS-CoV-2-positive vacinees, the first mRNA-1273 injection elicited bAb and nAb levels that were 11-fold (410 049) and 27-fold (1479) higher than in SARS-CoV-2-negative vaccinees, respectively, and were comparable to levels after 2 injections in uninfected participants. Findings were generally consistent by age and sex.
CONCLUSIONS
mRNA-1273 elicited robust serologic immune responses across age, sex, and SARS-CoV-2 status, consistent with its high COVID-19 efficacy. Higher immune responses in those previously infected support a booster-type effect. Clinical Trials Registration. NCT04470427.
Identifiants
pubmed: 35535503
pii: 6583011
doi: 10.1093/infdis/jiac188
pmc: PMC9213865
doi:
Substances chimiques
2019-nCoV Vaccine mRNA-1273
EPK39PL4R4
Antibodies, Neutralizing
0
Antibodies, Viral
0
COVID-19 Vaccines
0
RNA, Messenger
0
Spike Glycoprotein, Coronavirus
0
spike protein, SARS-CoV-2
0
Banques de données
ClinicalTrials.gov
['NCT04470427']
Types de publication
Clinical Trial, Phase III
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
1731-1742Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI148575
Pays : United States
Organisme : NIH HHS
ID : UM1 AI 68636
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069412
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068614
Pays : United States
Organisme : NIH HHS
ID : UM1 AI 68619
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI148684
Pays : United States
Organisme : NIH HHS
ID : UM1 AI 68635
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068635
Pays : United States
Organisme : NIH HHS
ID : UM1 AI 68614HVTN
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068617
Pays : United States
Organisme : NIH HHS
ID : UM1 AI148684-03
Pays : United States
Organisme : NIH HHS
ID : UM1 AI 68618
Pays : United States
Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Déclaration de conflit d'intérêts
Potential conflicts of interest. L. R. B., H. M. E., R. R., and S. S. report grants from NIH and/or NIAID during the conduct of the study. D. M. and A. M. disclose research funding from Moderna. R. P., Y. D. P., B. G., A. A., W. D., H. Z., and B. L. report being employees of Moderna, Inc. and may hold stock/stock options in the company. J. E. T. is a Moderna consultant. All other authors report no potential conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.