Scholars@Duke publication: Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.

Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.

Publication , Journal Article

Gilbert, PB; Montefiori, DC; McDermott, AB; Fong, Y; Benkeser, D; Deng, W; Zhou, H; Houchens, CR; Martins, K; Jayashankar, L; Castellino, F ...

Published in: Science

January 7, 2022

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In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines.

Duke Scholars

Author David Charles Montefiori Surgery, Surgical Sciences

Author Marcella Sarzotti-Kelsoe Integrative Immunobiology

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Published In

Science

DOI

10.1126/science.abm3425

EISSN

1095-9203

Publication Date

January 7, 2022

Volume

375

Issue

6576

Start / End Page

43 / 50

Location

United States

Related Subject Headings

Young Adult
Vaccine Efficacy
Spike Glycoprotein, Coronavirus
Sensitivity and Specificity
SARS-CoV-2
Randomized Controlled Trials as Topic
Middle Aged
Male
Immunogenicity, Vaccine
Humans

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Gilbert, P. B., Montefiori, D. C., McDermott, A. B., Fong, Y., Benkeser, D., Deng, W., … United States Government (USG)/CoVPN Biostatistics Team§, . (2022). Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial. Science, 375(6576), 43–50. https://doi.org/10.1126/science.abm3425

Gilbert, Peter B., David C. Montefiori, Adrian B. McDermott, Youyi Fong, David Benkeser, Weiping Deng, Honghong Zhou, et al. “Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.” Science 375, no. 6576 (January 7, 2022): 43–50. https://doi.org/10.1126/science.abm3425.

Gilbert PB, Montefiori DC, McDermott AB, Fong Y, Benkeser D, Deng W, et al. Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial. Science. 2022 Jan 7;375(6576):43–50.

Gilbert, Peter B., et al. “Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.” Science, vol. 375, no. 6576, Jan. 2022, pp. 43–50. Pubmed, doi:10.1126/science.abm3425.

Gilbert PB, Montefiori DC, McDermott AB, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O’Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA, Immune Assays Team§, Moderna, Inc. Team§, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§, United States Government (USG)/CoVPN Biostatistics Team§. Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial. Science. 2022 Jan 7;375(6576):43–50.

Published In

Science

DOI

10.1126/science.abm3425

EISSN

1095-9203

Publication Date

January 7, 2022

Volume

375

Issue

6576

Start / End Page

43 / 50

Location

United States

Related Subject Headings

Young Adult
Vaccine Efficacy
Spike Glycoprotein, Coronavirus
Sensitivity and Specificity
SARS-CoV-2
Randomized Controlled Trials as Topic
Middle Aged
Male
Immunogenicity, Vaccine
Humans