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Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.
- 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;
- Little, Susan;
- 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
- et al.
Published Web Location
https://doi.org/10.1038/s41564-022-01262-1Abstract
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 89% (78%, 96%) at ID50 = 96.3 IU50 ml-1. Comparison of the vaccine efficacy by ID50 titre curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine and the COV002-UK trial of the AZD1222 vaccine supported the ID50 titre as a correlate of protection across trials and vaccine types.
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