Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

PB Gilbert, DC Montefiori, AB McDermott, Y Fong… - Science, 2022 - science.org
Science, 2022science.org
In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed
for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as
correlates of protection. These immune markers were measured at the time of second
vaccination and 4 weeks later, with values reported in standardized World Health
Organization international units. All markers were inversely associated with COVID-19 risk
and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50 …
In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines.
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