Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial
Fong, Y.; McDermott, A. B.; Benkeser, D.; Roels, S.; Stieh, D. J.; Vandebosch, A.; Le Gars, M.; Van Roey, G. A.; Houchens, C. R.; Martins, K.; Jayashankar, L.; Castellino, F.; Amoa-Awua, O.; Basappa, M.; Flach, B.; Lin, B. C.; Moore, C.; Naisan, M.; Naqvi, M.; Narpala, S.; O'Connell, S.; Mueller, A.; Serebryannyy, L.; Castro, M.; Wang, J.; Petropoulos, C. J.; Luedtke, A.; Hyrien, O.; Lu, Y.; Yu, C.; Borate, B.; van der Laan, L. W. P.; Hejazi, N. S.; Kenny, A.; Carone, M.; Wolfe, D. N.; Sadoff, J.; Gray, G. E.; Grinsztejn, B.; Goepfert, P. A.; Little, S. J.; Paiva de Sousa, L.; Maboa, R.; Randh
Show abstract
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.
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