Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial
| Autor: | Michele P. Andrasik, Weiping Deng, Yiwen Lu, Bob C. Lin, Ruben O. Donis, Youyi Fong, Mira Baron, Lindsay N. Carpp, Lars W. P. van der Laan, Immune Assays Team, Adrian B. McDermott, Karen Martins, Lindsey R. Baden, Flora Castellino, James G. Kublin, Luis De La Cruz, Honghong Zhou, Chuong Huynh, Rolando Pajon, Amanda Eaton, David Benkeser, Mark Kutner, Dean Follmann, Marcella Sarzotti-Kelsoe, CoVPN Biostatistics Team, Hana M. El Sahly, Charlene McDanal, Jacqueline Miller, Christopher R. Houchens, Nima S. Hejazi, Kathleen M. Neuzil, Spyros A. Kalams, Bhavesh Borate, Coronavirus Efficacy (Cove) Team, David C. Montefiori, Lakshmi Jayashankar, Colleen F. Kelley, Richard A. Koup, Britta Flach, Peter B. Gilbert, Lawrence Corey, Chenchen Yu |
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| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | medRxiv article-version (status) pre article-version (number) 4 |
| ISSN: | 0447-0427 |
| Popis: | BackgroundIn the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection.MethodsThrough case-cohort sampling, participants were selected for measurement of four serum antibody markers at Day 1 (first dose), Day 29 (second dose), and Day 57: IgG binding antibodies (bAbs) to Spike, bAbs to Spike receptor-binding domain (RBD), and 50% and 80% inhibitory dilution pseudovirus neutralizing antibody titers calibrated to the WHO International Standard (cID50 and cID80). Participants with no evidence of previous SARS-CoV-2 infection were included. Cox regression assessed in vaccine recipients the association of each Day 29 or 57 serologic marker with COVID-19 through 126 or 100 days of follow-up, respectively, adjusting for risk factors.ResultsDay 57 Spike IgG, RBD IgG, cID50, and cID80 neutralization levels were each inversely correlated with risk of COVID-19: hazard ratios 0.66 (95% CI 0.50, 0.88; p=0.005); 0.57 (0.40, 0.82; p=0.002); 0.42 (0.27, 0.65; pConclusionsBinding and neutralizing antibodies correlated with COVID-19 risk and vaccine efficacy and likely have utility in predicting mRNA-1273 vaccine efficacy against COVID-19.Trial registration numberCOVEClinicalTrials.govnumber,NCT04470427 |
| Databáze: | OpenAIRE |
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