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

Authors :
Fong Y
McDermott AB
Benkeser D
Roels S
Stieh DJ
Vandebosch A
Gars ML
Van Roey GA
Houchens CR
Martins K
Jayashankar L
Castellino F
Amoa-Awua O
Basappa M
Flach B
Lin BC
Moore C
Naisan M
Naqvi M
Narpala S
O'Connell S
Mueller A
Serebryannyy L
Castro M
Wang J
Petropoulos CJ
Luedtke A
Hyrien O
Lu Y
Yu C
Borate B
van der Laan LWP
Hejazi NS
Kenny A
Carone M
Wolfe DN
Sadoff J
Gray GE
Grinsztejn B
Goepfert PA
Little SJ
de Sousa LP
Maboa R
Randhawa AK
Andrasik MP
Hendriks J
Truyers C
Struyf F
Schuitemaker H
Douoguih M
Kublin JG
Corey L
Neuzil KM
Carpp LN
Follmann D
Gilbert PB
Koup RA
Donis RO
Source :
MedRxiv : the preprint server for health sciences [medRxiv] 2022 Apr 12. Date of Electronic Publication: 2022 Apr 12.
Publication Year :
2022

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.

Details

Language :
English
Database :
MEDLINE
Journal :
MedRxiv : the preprint server for health sciences
Publication Type :
Academic Journal
Accession number :
35441174
Full Text :
https://doi.org/10.1101/2022.04.06.22272763