tetano
Editor, Senior Moderator
Nat Commun
. 2023 Jan 19;14(1):331.
doi: 10.1038/s41467-022-35768-3.
Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
Youyi Fong[SUP] 1 2 [/SUP], Yunda Huang[SUP] 1 3 [/SUP], David Benkeser[SUP] 4 [/SUP], Lindsay N Carpp[SUP] 1 [/SUP], Germán Áñez[SUP] 5 [/SUP], Wayne Woo[SUP] 5 [/SUP], Alice McGarry[SUP] 5 [/SUP], Lisa M Dunkle[SUP] 5 [/SUP], Iksung Cho[SUP] 5 [/SUP], Christopher R Houchens[SUP] 6 [/SUP], Karen Martins[SUP] 6 [/SUP], Lakshmi Jayashankar[SUP] 6 [/SUP], Flora Castellino[SUP] 6 [/SUP], Christos J Petropoulos[SUP] 7 [/SUP], Andrew Leith[SUP] 8 [/SUP], Deanne Haugaard[SUP] 8 [/SUP], Bill Webb[SUP] 8 [/SUP], Yiwen Lu[SUP] 1 [/SUP], Chenchen Yu[SUP] 1 [/SUP], Bhavesh Borate[SUP] 1 [/SUP], Lars W P van der Laan[SUP] 1 9 [/SUP], Nima S Hejazi[SUP] 1 10 [/SUP], April K Randhawa[SUP] 1 [/SUP], Michele P Andrasik[SUP] 1 [/SUP], James G Kublin[SUP] 1 [/SUP], Julia Hutter[SUP] 11 [/SUP], Maryam Keshtkar-Jahromi[SUP] 11 [/SUP], Tatiana H Beresnev[SUP] 11 [/SUP], Lawrence Corey[SUP] 1 12 [/SUP], Kathleen M Neuzil[SUP] 13 [/SUP], Dean Follmann[SUP] 14 [/SUP], Julie A Ake[SUP] 15 [/SUP], Cynthia L Gay[SUP] 16 [/SUP], Karen L Kotloff[SUP] 13 [/SUP], Richard A Koup[SUP] #[/SUP][SUP] 17 [/SUP], Ruben O Donis[SUP] #[/SUP][SUP] 6 [/SUP], Peter B Gilbert[SUP] #[/SUP][SUP] 18 19 20 [/SUP]; Immune Assays Team; Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team; United States Government (USG)/CoVPN Biostatistics Team
Affiliations
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.
. 2023 Jan 19;14(1):331.
doi: 10.1038/s41467-022-35768-3.
Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
Youyi Fong[SUP] 1 2 [/SUP], Yunda Huang[SUP] 1 3 [/SUP], David Benkeser[SUP] 4 [/SUP], Lindsay N Carpp[SUP] 1 [/SUP], Germán Áñez[SUP] 5 [/SUP], Wayne Woo[SUP] 5 [/SUP], Alice McGarry[SUP] 5 [/SUP], Lisa M Dunkle[SUP] 5 [/SUP], Iksung Cho[SUP] 5 [/SUP], Christopher R Houchens[SUP] 6 [/SUP], Karen Martins[SUP] 6 [/SUP], Lakshmi Jayashankar[SUP] 6 [/SUP], Flora Castellino[SUP] 6 [/SUP], Christos J Petropoulos[SUP] 7 [/SUP], Andrew Leith[SUP] 8 [/SUP], Deanne Haugaard[SUP] 8 [/SUP], Bill Webb[SUP] 8 [/SUP], Yiwen Lu[SUP] 1 [/SUP], Chenchen Yu[SUP] 1 [/SUP], Bhavesh Borate[SUP] 1 [/SUP], Lars W P van der Laan[SUP] 1 9 [/SUP], Nima S Hejazi[SUP] 1 10 [/SUP], April K Randhawa[SUP] 1 [/SUP], Michele P Andrasik[SUP] 1 [/SUP], James G Kublin[SUP] 1 [/SUP], Julia Hutter[SUP] 11 [/SUP], Maryam Keshtkar-Jahromi[SUP] 11 [/SUP], Tatiana H Beresnev[SUP] 11 [/SUP], Lawrence Corey[SUP] 1 12 [/SUP], Kathleen M Neuzil[SUP] 13 [/SUP], Dean Follmann[SUP] 14 [/SUP], Julie A Ake[SUP] 15 [/SUP], Cynthia L Gay[SUP] 16 [/SUP], Karen L Kotloff[SUP] 13 [/SUP], Richard A Koup[SUP] #[/SUP][SUP] 17 [/SUP], Ruben O Donis[SUP] #[/SUP][SUP] 6 [/SUP], Peter B Gilbert[SUP] #[/SUP][SUP] 18 19 20 [/SUP]; Immune Assays Team; Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team; United States Government (USG)/CoVPN Biostatistics Team
Affiliations
- PMID: 36658109
- DOI: 10.1038/s41467-022-35768-3
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.