학술논문
Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.
Document Type
article
Author
Fong, Youyi; McDermott, Adrian; Benkeser, David; Roels, Sanne; Stieh, Daniel; Vandebosch, An; Le Gars, Mathieu; Van Roey, Griet; Houchens, Christopher; Martins, Karen; Jayashankar, Lakshmi; Castellino, Flora; Amoa-Awua, Obrimpong; Basappa, Manjula; Flach, Britta; Lin, Bob; Moore, Christopher; Naisan, Mursal; Naqvi, Muhammed; Narpala, Sandeep; OConnell, Sarah; Mueller, Allen; Serebryannyy, Leo; Castro, Mike; Wang, Jennifer; Petropoulos, Christos; Luedtke, Alex; Hyrien, Ollivier; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; van der Laan, Lars; Hejazi, Nima; Kenny, Avi; Carone, Marco; Wolfe, Daniel; Sadoff, Jerald; Gray, Glenda; Grinsztejn, Beatriz; Goepfert, Paul; Paiva de Sousa, Leonardo; Maboa, Rebone; Randhawa, April; Andrasik, Michele; Hendriks, Jenny; Truyers, Carla; Struyf, Frank; Schuitemaker, Hanneke; Douoguih, Macaya; Kublin, James; Corey, Lawrence; Neuzil, Kathleen; Carpp, Lindsay; Follmann, Dean; Gilbert, Peter; Koup, Richard; Donis, Ruben; Little, Susan
Source
Nature Microbiology. 7(12)
Subject
Language
Abstract
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 (