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

Peter B. Gilbert(University of Washington), David C. Montefiori(Duke Medical Center), Adrian B. McDermott(National Institutes of Health), Youyi Fong(Fred Hutch Cancer Center), David Benkeser(Emory University), Weiping Deng(Moderna Therapeutics (United States)), Honghong Zhou(Moderna Therapeutics (United States)), Christopher R. Houchens(Biomedical Advanced Research and Development Authority), Karen Martins(Biomedical Advanced Research and Development Authority), Lakshmi Jayashankar(Biomedical Advanced Research and Development Authority), Flora Castellino(Biomedical Advanced Research and Development Authority), Britta Flach(National Institutes of Health), Bob C. Lin(National Institutes of Health), Sarah O’Connell(National Institutes of Health), Charlene McDanal(Duke Medical Center), Amanda Eaton(Duke Medical Center), Marcella Sarzotti‐Kelsoe(Duke Medical Center), Yiwen Lu(Fred Hutch Cancer Center), Chenchen Yu(Fred Hutch Cancer Center), Bhavesh Borate(Fred Hutch Cancer Center), Lars W. P. van der Laan(Fred Hutch Cancer Center), Nima S. Hejazi(Fred Hutch Cancer Center), Chuong Huynh(Biomedical Advanced Research and Development Authority), Jacqueline M. Miller(Moderna Therapeutics (United States)), Hana M. El Sahly(Baylor College of Medicine), Lindsey R. Baden(Brigham and Women's Hospital), Mira Baron(Palm Beach Neurology), Luis de la Cruz‐Merino(Keystone College), Cynthia L. Gay(University of North Carolina at Chapel Hill), Spyros A. Kalams(Vanderbilt University Medical Center), Colleen F. Kelley(Grady Memorial Hospital), Michele P. Andrasik(Fred Hutch Cancer Center), James G. Kublin(Fred Hutch Cancer Center), Lawrence Corey(University of Washington), Kathleen M. Neuzil(University of Maryland, Baltimore), Lindsay N. Carpp(Fred Hutch Cancer Center), Rolando Pajón(Moderna Therapeutics (United States)), Dean Follmann(National Institutes of Health), Rubén O. Donis(Biomedical Advanced Research and Development Authority), Richard A. Koup(National Institutes of Health), Immune Assays Team§, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§, United States Government (USG)/CoVPN Biostatistics Team§
Science
January 6, 2022
10.1126/science.abm3425
Cited by 1,193Open Access
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Abstract

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.

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