medRxiv : the preprint server for health sciences · 2022

Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial.

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Fong Youyi, McDermott Adrian B, Benkeser David, Roels Sanne, Stieh Daniel J, Vandebosch An, Gars Mathieu Le, 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, de Sousa Leonardo Paiva, 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, Janssen Team, Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team, United States Government (USG)/CoVPN Biostatistics Team

Аннотация

Anti-spike IgG binding antibody, anti-receptor binding domain IgG antibody, and pseudovirus neutralizing antibody measurements four weeks post-vaccination were assessed as correlates of risk of moderate to severe-critical COVID-19 outcomes through 83 days post-vaccination and as correlates of protection following a single dose of Ad26.COV2.S COVID-19 vaccine in the placebo-controlled phase of ENSEMBLE, an international, randomized efficacy trial. Each marker had evidence as a correlate of risk and of protection, with strongest evidence for 50% inhibitory dilution (ID50) neutralizing antibody titer. 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 nonquantifiable ID50 (< 2.7 IU50/ml) and rose to 89% (78, 96%) at ID50 = 96.3 IU50/ml. Comparison of the vaccine efficacy by ID50 titer curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine, and the COV002-UK trial of the AZD1222 vaccine supported consistency of the ID50 titer correlate of protection across trials and vaccine types.

Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial.

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