Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
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.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Jan 19, 2023
- Source ID
- 10.1038/s41467-022-35768-3
Entities
People
- Alice Mcgarry
- Andrew Leith
- April K Randhawa
- Bhavesh Borate
- Bill Webb
- Chenchen Yu
- Christopher R. Houchens
- Christos J. Petropoulos
- Coronavirus Vaccine Prevention Network (covpn)/2019ncov-301 Principal Investigators And Study Team
- Cynthia L Gay
- David Benkeser
- Dean Follmann
- Deanne Haugaard
- Flora Castellino
- Germán Añez
- Iksung Cho
- Immune Assays Team
- James G. Kublin
- Julia Hutter
- Julie A. Ake
- Karen A Martins
- Karen L. Kotloff
- Kathleen Neuzil
- Lakshmi Jayashankar
- Lars W. P. Van Der Laan
- Lawrence Corey
- Lindsay N Carpp
- Lisa M. Dunkle
- Maryam Keshtkar-Jahromi
- Michele P. Andrasik
- Nima S Hejazi
- Peter B Gilbert
- Richard A. Koup
- Ruben O. Donis
- Tatiana H. Beresnev
- United States Government (usg)/covpn Biostatistics Team
- Wayne Woo
- Yiwen Lu
- Youyi Fong
- Yunda Huang
Organizations
- National Institute of Allergy and Infectious Diseases
- United States Department of Health and Human Services