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Gilbert, Peter B; Montefiori, David C; McDermott, Adrian B; Fong, Youyi; Benkeser, David; Deng, Weiping; Zhou, Honghong; Houchens, Christopher R; Martins, Karen; Jayashankar, Lakshmi; Castellino, Flora; Flach, Britta; Lin, Bob C; O'Connell, Sarah; McDanal, Charlene; Eaton, Amanda; Sarzotti-Kelsoe, Marcella; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; van der Laan, Lars W P; Hejazi, Nima S; Huynh, Chuong; Miller, Jacqueline; El Sahly, Hana M; Baden, Lindsey R; Baron, Mira; De La Cruz, Luis; Gay, Cynthia; Kalams, Spyros; Kelley, Colleen F; Andrasik, Michele P; Kublin, James G; Corey, Lawrence; Neuzil, Kathleen M; Carpp, Lindsay N; Pajon, Rolando; Follmann, Dean; Donis, Ruben O; Koup, Richard A
Science (American Association for the Advancement of Science), 01/2022, Letnik: 375, Številka: 6576Journal Article
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.
