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

Youyi Fong, Yunda Huang, David Benkeser, Lindsay N. Carpp, Germán Áñez, Wayne Woo, Alice McGarry, Lisa M. Dunkle, Iksung Cho, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Julia Hutter, Maryam Keshtkar-Jahromi, Tatiana H. Beresnev, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Julie A. Ake, Cynthia L. Gay, Karen L. Kotloff, Richard A. Koup, Ruben O. Donis and Peter B. Gilbert ()
Additional contact information
Youyi Fong: Fred Hutchinson Cancer Center
Yunda Huang: Fred Hutchinson Cancer Center
David Benkeser: Emory University
Lindsay N. Carpp: Fred Hutchinson Cancer Center
Germán Áñez: Novavax, Inc.
Wayne Woo: Novavax, Inc.
Alice McGarry: Novavax, Inc.
Lisa M. Dunkle: Novavax, Inc.
Iksung Cho: Novavax, Inc.
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
Christos J. Petropoulos: LabCorp-Monogram Biosciences
Andrew Leith: Nexelis
Deanne Haugaard: Nexelis
Bill Webb: Nexelis
Yiwen Lu: Fred Hutchinson Cancer Center
Chenchen Yu: Fred Hutchinson Cancer Center
Bhavesh Borate: Fred Hutchinson Cancer Center
Lars W. P. van der Laan: Fred Hutchinson Cancer Center
Nima S. Hejazi: Fred Hutchinson Cancer Center
April K. Randhawa: Fred Hutchinson Cancer Center
Michele P. Andrasik: Fred Hutchinson Cancer Center
James G. Kublin: Fred Hutchinson Cancer Center
Julia Hutter: National Institute of Allergy and Infectious Diseases, NIH
Maryam Keshtkar-Jahromi: National Institute of Allergy and Infectious Diseases, NIH
Tatiana H. Beresnev: National Institute of Allergy and Infectious Diseases, NIH
Lawrence Corey: Fred Hutchinson Cancer Center
Kathleen M. Neuzil: University of Maryland School of Medicine
Dean Follmann: National Institutes of Health
Julie A. Ake: Walter Reed Army Institute of Research
Cynthia L. Gay: University of North Carolina School of Medicine
Karen L. Kotloff: University of Maryland School of Medicine
Richard A. Koup: National Institutes of Health
Ruben O. Donis: Biomedical Advanced Research and Development Authority
Peter B. Gilbert: Fred Hutchinson Cancer Center

Nature Communications, 2023, vol. 14, issue 1, 1-15

Abstract: Abstract In the PREVENT-19 phase 3 trial of the NVX-CoV2373 vaccine (NCT04611802), anti-spike binding IgG concentration (spike IgG), anti-RBD binding IgG concentration (RBD IgG), and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured two weeks post-dose two are assessed as correlates of risk and as correlates of protection against COVID-19. Analyses are conducted in the U.S. cohort of baseline SARS-CoV-2 negative per-protocol participants using a case-cohort design that measures the markers from all 12 vaccine recipient breakthrough COVID-19 cases starting 7 days post antibody measurement and from 639 vaccine recipient non-cases. All markers are inversely associated with COVID-19 risk and directly associated with vaccine efficacy. In vaccine recipients with nAb ID50 titers of 50, 100, and 7230 international units (IU50)/ml, vaccine efficacy estimates are 75.7% (49.8%, 93.2%), 81.7% (66.3%, 93.2%), and 96.8% (88.3%, 99.3%). The results support potential cross-vaccine platform applications of these markers for guiding decisions about vaccine approval and use.

Date: 2023
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DOI: 10.1038/s41467-022-35768-3

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