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

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Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
Science ( IF 56.9 ) Pub Date : 2021-11-23 , DOI: 10.1126/science.abm3425
Peter B. Gilbert _{1,

2,

3} , David C. Montefiori ₄ , Adrian B. McDermott ₅ , Youyi Fong _{1,

2} , David Benkeser ₆ , Weiping Deng ₇ , Honghong Zhou ₇ , Christopher R. Houchens ₈ , Karen Martins ₈ , Lakshmi Jayashankar ₈ , Flora Castellino ₈ , Britta Flach ₅ , Bob C. Lin ₅ , Sarah O’Connell ₅ , Charlene McDanal ₄ , Amanda Eaton ₄ , Marcella Sarzotti-Kelsoe ₄ , Yiwen Lu ₁ , Chenchen Yu ₁ , Bhavesh Borate ₁ , Lars W. P. van der Laan ₁ , Nima S. Hejazi _{1,

9} , Chuong Huynh ₈ , Jacqueline Miller ₇ , Hana M. El Sahly ₁₀ , Lindsey R. Baden ₁₁ , Mira Baron ₁₂ , Luis De La Cruz ₁₃ , Cynthia Gay ₁₄ , Spyros Kalams ₁₅ , Colleen F. Kelley ₁₆ , Michele P. Andrasik ₁ , James G. Kublin ₁ , Lawrence Corey _{1,

17} , Kathleen M. Neuzil ₁₈ , Lindsay N. Carpp ₁ , Rolando Pajon ₇ , Dean Follmann ₁₉ , Ruben O. Donis ₈ , Richard A. Koup ₅ , , , ,

Affiliation

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Department of Biostatistics, University of Washington, Seattle, WA, USA.
Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Moderna, Inc., Cambridge, MA, USA.
Biomedical Advanced Research and Development Authority, Washington, DC, USA.
Division of Biostatistics, School of Public Health, University of California Berkeley, Berkeley, CA, USA.
Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
Brigham and Women’s Hospital, Boston, MA, USA.
Palm Beach Research Center, West Palm Beach, FL, USA.
Keystone Vitalink Research, Greenville, SC, USA.
Department of Medicine, Division of Infectious Diseases, UNC HIV Cure Center, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine and the Grady Health System, Atlanta, GA, USA.
Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

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 second vaccination and 4 weeks later, with values reported in standardized WHO International Units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with post-vaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacy of 78% (95% confidence interval 54, 89%), 91% (87, 94%), and 96% (94, 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for mRNA COVID-19 vaccines and other COVID-19 vaccines.

中文翻译：

mRNA-1273 COVID-19疫苗功效临床试验的免疫相关性分析

在冠状病毒功效 (COVE) 3 期临床试验中，评估了疫苗接受者的中和抗体和结合抗体作为 COVID-19 疾病风险的相关因素和保护的相关因素。在第二次接种疫苗和 4 周后测量这些免疫标记物，并以标准化的 WHO 国际单位报告值。所有标志物都与 COVID-19 风险呈负相关，并与疫苗效力直接相关。接种后 50% 中和滴度为 10、100 和 1000 的疫苗接受者估计疫苗效力为 78%（95% 置信区间 54、89%）、91%（87、94%）和 96%（94、98 ％），分别。这些结果有助于定义与保护相关的免疫标记物，并可能指导 mRNA COVID-19 疫苗和其他 COVID-19 疫苗的批准决策。

更新日期：2021-11-24

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