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

2023; Nature Portfolio; Volume: 14; Issue: 1 Linguagem: Inglês

10.1038/s41467-022-35768-3

2041-1723

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 Randhawa, Michele P. Andrasik, James G. Kublin, Julia Hütter, Maryam Keshtkar‐Jahromi, Tatiana Beresnev, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Julie A. Ake, Cynthia L. Gay, Karen L. Kotloff, Richard A. Koup, Rubén O. Donis, Peter B. Gilbert,

COVID-19 Clinical Research Studies

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.