作者
Peter B Gilbert, David C Montefiori, Adrian B McDermott, Youyi Fong, David Benkeser, Weiping Deng, Honghong Zhou, Christopher R Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Britta Flach, Bob C Lin, Sarah O’Connell, Charlene McDanal, Amanda Eaton, Marcella Sarzotti-Kelsoe, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars WP van der Laan, Nima S Hejazi, Chuong Huynh, Jacqueline Miller, Hana M El Sahly, Lindsey R Baden, Mira Baron, Luis De La Cruz, Cynthia Gay, Spyros Kalams, Colleen F Kelley, Michele P Andrasik, James G Kublin, Lawrence Corey, Kathleen M Neuzil, Lindsay N Carpp, Rolando Pajon, Dean Follmann, Ruben O Donis, Richard A Koup, Immune Assays Team §, Moderna, Inc. Team §, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team §, United States Government (USG)/CoVPN Biostatistics Team §
发表日期
2022/1/7
期刊
Science
卷号
375
期号
6576
页码范围
43-50
出版商
American Association for the Advancement of Science
简介
In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines.
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PB Gilbert, DC Montefiori, AB McDermott, Y Fong… - Science, 2022