TY - JOUR
T1 - Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
AU - Immune Assays Team
AU - Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team
AU - United States Government (USG)/CoVPN Biostatistics Team
AU - Fong, Youyi
AU - Huang, Yunda
AU - Benkeser, David
AU - Carpp, Lindsay N.
AU - Áñez, Germán
AU - Woo, Wayne
AU - McGarry, Alice
AU - Dunkle, Lisa M.
AU - Cho, Iksung
AU - Houchens, Christopher R.
AU - Martins, Karen
AU - Jayashankar, Lakshmi
AU - Castellino, Flora
AU - Petropoulos, Christos J.
AU - Leith, Andrew
AU - Haugaard, Deanne
AU - Webb, Bill
AU - Lu, Yiwen
AU - Yu, Chenchen
AU - Borate, Bhavesh
AU - van der Laan, Lars W.P.
AU - Hejazi, Nima S.
AU - Randhawa, April K.
AU - Andrasik, Michele P.
AU - Kublin, James G.
AU - Hutter, Julia
AU - Keshtkar-Jahromi, Maryam
AU - Beresnev, Tatiana H.
AU - Corey, Lawrence
AU - Neuzil, Kathleen M.
AU - Follmann, Dean
AU - Ake, Julie A.
AU - Gay, Cynthia L.
AU - Kotloff, Karen L.
AU - Koup, Richard A.
AU - Donis, Ruben O.
AU - Gilbert, Peter B.
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85146615733&partnerID=8YFLogxK
U2 - 10.1038/s41467-022-35768-3
DO - 10.1038/s41467-022-35768-3
M3 - Article
C2 - 36658109
AN - SCOPUS:85146615733
SN - 2041-1723
VL - 14
JO - Nature Communications
JF - Nature Communications
IS - 1
M1 - 331
ER -