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DOI 10.1126/science.abm3425

Медицинская библиотека · Science (New York, N.Y.) · 2021

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

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, Immune Assays Team§, Moderna, Inc. Team§, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§, United States Government (USG)/CoVPN Biostatistics Team§

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Аннотация

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.

Для цитирования: 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, Immune Assays Team§, Moderna, Inc. Team§, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§, United States Government (USG)/CoVPN Biostatistics Team§. Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.. Science (New York, N.Y.). 2021. DOI: 10.1126/science.abm3425.

Предметные рубрики MeSH

2019-nCoV Vaccine mRNA-1273AdolescentAdultAgedAntibodies, NeutralizingAntibodies, ViralCOVID-19Clinical Trials, Phase III as TopicFemaleHumansImmunogenicity, VaccineMaleMiddle AgedRandomized Controlled Trials as TopicSARS-CoV-2Sensitivity and SpecificitySpike Glycoprotein, CoronavirusVaccine EfficacyYoung Adult
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