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

• Published in: Science (American Association for the Advancement of Science) Vol. 375; no. 6576; pp. 43 - 50
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States The American Association for the Advancement of Science 07.01.2022; American Association for the Advancement of Science
• Subjects: 2019-nCoV Vaccine mRNA-1273 - immunology; Adolescent; Adult; Aged; Antibodies; Antibodies, Neutralizing - blood; Antibodies, Neutralizing - immunology; Antibodies, Viral - blood; Antibodies, Viral - immunology; Binding; Biomarkers; Clinical trials; Clinical Trials, Phase III as Topic; Comp/Math; Confidence intervals; Coronavirus; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 vaccines; Female; Health risks; Humans; Immunization; Immunization Programs; Immunogenicity, Vaccine; Immunology; Infections; Male; Middle Aged; mRNA; Neutralization; Neutralizing; Randomized Controlled Trials as Topic; Respiratory diseases; SARS-CoV-2 - immunology; Sensitivity and Specificity; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Spike Glycoprotein, Coronavirus - immunology; Spike protein; Vaccine Efficacy; Vaccines; Viral diseases; Young Adult
• ISSN: 0036-8075; 1095-9203; 1095-9203
• DOI: 10.1126/science.abm3425

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.