Details

Autor(en) / Beteiligte

• Fong, Youyi
• McDermott, Adrian B
• Benkeser, David
• Roels, Sanne
• Stieh, Daniel J
• Vandebosch, An
• Le Gars, Mathieu
• Van Roey, Griet A
• Houchens, Christopher R
• Martins, Karen
• Jayashankar, Lakshmi
• Castellino, Flora
• Amoa-Awua, Obrimpong
• Basappa, Manjula
• Flach, Britta
• Lin, Bob C
• Moore, Christopher
• Naisan, Mursal
• Naqvi, Muhammed
• Narpala, Sandeep
• O'Connell, Sarah
• Mueller, Allen
• Serebryannyy, Leo
• Castro, Mike
• Wang, Jennifer
• Petropoulos, Christos J
• Luedtke, Alex
• Hyrien, Ollivier
• Lu, Yiwen
• Yu, Chenchen
• Borate, Bhavesh
• van der Laan, Lars W P
• Hejazi, Nima S
• Kenny, Avi
• Carone, Marco
• Wolfe, Daniel N
• Sadoff, Jerald
• Gray, Glenda E
• Grinsztejn, Beatriz
• Goepfert, Paul A
• Little, Susan J
• Paiva de Sousa, Leonardo
• Maboa, Rebone
• Randhawa, April K
• Andrasik, Michele P
• Hendriks, Jenny
• Truyers, Carla
• Struyf, Frank
• Schuitemaker, Hanneke
• Douoguih, Macaya
• Kublin, James G
• Corey, Lawrence
• Neuzil, Kathleen M
• Carpp, Lindsay N
• Follmann, Dean
• Gilbert, Peter B
• Koup, Richard A
• Donis, Ruben O

Titel

Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial

Ist Teil von

• Nature microbiology, 2022-12, Vol.7 (12), p.1996

Ort / Verlag

England

Erscheinungsjahr

2022

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 (ID ) 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 ID ; vaccine efficacy was 60% (43%, 72%) at non-quantifiable ID (<2.7 IU  ml ) and increased to 89% (78%, 96%) at ID  = 96.3 IU  ml . Comparison of the vaccine efficacy by ID titre curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine and the COV002-UK trial of the AZD1222 vaccine supported the ID titre as a correlate of protection across trials and vaccine types.