Artigo Acesso aberto Revisado por pares

Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

2022; American Association for the Advancement of Science; Volume: 375; Issue: 6576 Linguagem: Inglês

10.1126/science.abm3425

ISSN

1095-9203

Autores

Peter B. Gilbert, David C. Montefiori, Adrian B. McDermott, Youyi Fong, David Benkeser, Weiping Deng, Haiyu 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 W. P. van der Laan, Nima S. Hejazi, Chuong Huynh, Jacqueline M. Miller, Hana M. El Sahly, Lindsey R. Baden, Mira Baron, Luis de la Cruz‐Merino, Cynthia L. Gay, Spyros A. Kalams, Colleen F. Kelley, Michele P. Andrasik, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Lindsay N. Carpp, Rolando Pajón, Dean Follmann, Ruben O. Donis, Richard A. Koup,

Tópico(s)

Animal Virus Infections Studies

Resumo

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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