![]() The ENSEMBLE trial ( NCT04505722, ) was carried out in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States to test the efficacy of a single dose of the replication-incompetent human adenovirus type 26 (Ad26)-vectored vaccine vs placebo to prevent moderate to severe-critical COVID-19 1, 2. ![]() Comparison of the vaccine efficacy by ID 50 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 50 titre as a correlate of protection across trials and vaccine types. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID 50) neutralizing antibody titre as a correlate of risk and of protection. We also evaluated correlates of protection in the trial cohort. 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. Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. Nature Microbiology volume 7, pages 1996–2010 ( 2022) Cite this article and the United States Government (USG)/CoVPN Biostatistics Team.the Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team &. ![]() ![]() Immune correlates analysis of the ENSEMBLE single dose vaccine efficacy clinical trial ![]()
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