作者
Youyi Fong, Adrian B McDermott, David Benkeser, Sanne Roels, Daniel J Stieh, An Vandebosch, Mathieu Le Gars, Griet A Van Roey, Christopher R Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Obrimpong Amoa-Awua, Manjula Basappa, Britta Flach, Bob C Lin, Christopher Moore, Mursal Naisan, Muhammed Naqvi, Sandeep Narpala, Sarah O’Connell, Allen Mueller, Leo Serebryannyy, Mike Castro, Jennifer Wang, Christos J Petropoulos, Alex Luedtke, Ollivier Hyrien, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars WP van Der Laan, Nima S Hejazi, Avi Kenny, Marco Carone, Daniel N Wolfe, Jerald Sadoff, Glenda E Gray, Beatriz Grinsztejn, Paul A Goepfert, Susan J Little, Leonardo Paiva de Sousa, Rebone Maboa, April K Randhawa, Michele P Andrasik, Jenny Hendriks, Carla Truyers, Frank Struyf, Hanneke Schuitemaker, Macaya Douoguih, James G Kublin, Lawrence Corey, Kathleen M Neuzil, Lindsay N Carpp, Dean Follmann, Peter B Gilbert, Richard A Koup, Ruben O Donis, Immune Assays Team, Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team, United States Government (USG)/CoVPN Biostatistics Team
发表日期
2022/12
期刊
Nature microbiology
卷号
7
期号
12
页码范围
1996-2010
出版商
Nature Publishing Group UK
简介
Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of moderate to severe-critical COVID-19 through 83 d post vaccination in the phase 3, double-blind placebo-controlled phase of ENSEMBLE, an international randomized efficacy trial of a single dose of Ad26.COV2.S. We also evaluated correlates of protection in the trial cohort. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID50) neutralizing antibody titre as a correlate of risk and of protection. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; P = 0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43%, 72%) at non-quantifiable ID50 (<2.7 IU50 ml−1) and increased to …
学术搜索中的文章
Immune correlates analysis of the ENSEMBLE single Ad26. COV2. S dose vaccine efficacy clinical trial
Y Fong, AB McDermott, D Benkeser, S Roels, DJ Stieh… - Nature microbiology, 2022