Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial

Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial

The COVE trial randomized participants to receive two doses of mRNA-1273 vaccine or placebo on Days 1 and 29 (D1, D29). Anti-SARS-CoV-2 Spike IgG binding antibodies (bAbs), anti-receptor binding domain IgG bAbs, 50% inhibitory dilution neutralizing antibody (nAb) titers, and 80% inhibitory dilution...

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Bibliographic Details
Main Authors: Ying Huang, Nima S. Hejazi, Bryan Blette, Lindsay N. Carpp, David Benkeser, David C. Montefiori, Adrian B. McDermott, Youyi Fong, Holly E. Janes, Weiping Deng, Honghong Zhou, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Britta Flach, Bob C. Lin, Sarah O’Connell, Charlene McDanal, Amanda Eaton, Marcella Sarzotti-Kelsoe, Yiwen Lu, Chenchen Yu, Avi Kenny, Marco Carone, Chuong Huynh, Jacqueline Miller, Hana M. El Sahly, Lindsey R. Baden, Lisa A. Jackson, Thomas B. Campbell, Jesse Clark, Michele P. Andrasik, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Rolando Pajon, Dean Follmann, Ruben O. Donis, Richard A. Koup, Peter B. Gilbert, on behalf of the Immune Assays, Moderna, Inc., Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE), United States Government (USG)/CoVPN Biostatistics Teams
Format: Article
Language:English
Published: MDPI AG 2023-09-01
Series:Viruses
Subjects:
binding antibody assay
immune correlates of protection
modified treatment policy
neutralizing antibody assay
principal stratification
principal surrogate
Online Access:https://www.mdpi.com/1999-4915/15/10/2029

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https://www.mdpi.com/1999-4915/15/10/2029

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