Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial

Bo Zhang, Youyi Fong, Jonathan Fintzi, Eric Chu, Holly E. Janes, Avi Kenny, Marco Carone, David Benkeser, Lars W. P. Laan, Weiping Deng, Honghong Zhou, Xiaowei Wang, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Haiyan Chen, Isabel Reeder, Lindsay N. Carpp, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Chuong Huynh, Carl J. Fichtenbaum, Spyros Kalams, Cynthia L. Gay, Michele P. Andrasik, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Frances Priddy, Rituparna Das, Bethany Girard, Hana M. El Sahly, Lindsey R. Baden, Thomas Jones, Ruben O. Donis, Richard A. Koup, Peter B. Gilbert and Dean Follmann ()
Additional contact information
Bo Zhang: Fred Hutchinson Cancer Center
Youyi Fong: Fred Hutchinson Cancer Center
Jonathan Fintzi: National Institute of Allergy and Infectious Diseases, National Institutes of Health
Eric Chu: Frederick National Laboratory for Cancer Research
Holly E. Janes: Fred Hutchinson Cancer Center
Avi Kenny: University of Washington
Marco Carone: University of Washington
David Benkeser: Emory University
Lars W. P. Laan: University of Washington
Weiping Deng: Moderna, Inc
Honghong Zhou: Moderna, Inc
Xiaowei Wang: Moderna, Inc
Yiwen Lu: Fred Hutchinson Cancer Center
Chenchen Yu: Fred Hutchinson Cancer Center
Bhavesh Borate: Fred Hutchinson Cancer Center
Haiyan Chen: Biomedical Advanced Research and Development Authority
Isabel Reeder: Biomedical Advanced Research and Development Authority
Lindsay N. Carpp: Fred Hutchinson Cancer Center
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
Chuong Huynh: Biomedical Advanced Research and Development Authority
Carl J. Fichtenbaum: University of Cincinnati
Spyros Kalams: Vanderbilt University Medical Center
Cynthia L. Gay: University of North Carolina at Chapel Hill School of Medicine
Michele P. Andrasik: Fred Hutchinson Cancer Center
James G. Kublin: Fred Hutchinson Cancer Center
Lawrence Corey: Fred Hutchinson Cancer Center
Kathleen M. Neuzil: University of Maryland School of Medicine
Frances Priddy: Moderna, Inc
Rituparna Das: Moderna, Inc
Bethany Girard: Moderna, Inc
Hana M. El Sahly: Baylor College of Medicine
Lindsey R. Baden: Brigham and Women’s Hospital
Thomas Jones: Biomedical Advanced Research and Development Authority
Ruben O. Donis: Biomedical Advanced Research and Development Authority
Richard A. Koup: National Institute of Allergy and Infectious Diseases, National Institutes of Health
Peter B. Gilbert: Fred Hutchinson Cancer Center
Dean Follmann: National Institute of Allergy and Infectious Diseases, National Institutes of Health

Nature Communications, 2024, vol. 15, issue 1, 1-13

Abstract: Abstract In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-CoV-2 naive participants. In the SARS-CoV-2 Omicron era, Omicron subvariants with varying degrees of immune escape now dominate, seropositivity rates are high, and booster doses are administered, raising questions on whether and how these developments affect the bAb and nAb correlates. To address these questions, we assess post-boost BA.1 Spike-specific bAbs and nAbs as CoRs and as correlates of booster efficacy in COVE. For naive individuals, bAbs and nAbs inversely correlate with Omicron COVID-19: hazard ratios (HR) per 10-fold marker increase (95% confidence interval) are 0.16 (0.03, 0.79) and 0.31 (0.10, 0.96), respectively. In non-naive individuals the analogous results are similar: 0.15 (0.04, 0.63) and 0.28 (0.07, 1.08). For naive individuals, three vs two-dose booster efficacy correlates with predicted nAb titer at exposure, with estimates -8% (-126%, 48%), 50% (25%, 67%), and 74% (49%, 87%), at 56, 251, and 891 Arbitrary Units/ml. These results support the continued use of antibody as a surrogate endpoint.

Date: 2024
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DOI: 10.1038/s41467-024-52348-9

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