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

Science. 2022 Jan 7;375(6576):43-50. doi: 10.1126/science.abm3425. Epub 2021 Nov 23.

Abstract

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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • 2019-nCoV Vaccine mRNA-1273 / immunology*
  • Adolescent
  • Adult
  • Aged
  • Antibodies, Neutralizing / blood*
  • Antibodies, Neutralizing / immunology
  • Antibodies, Viral / blood*
  • Antibodies, Viral / immunology
  • COVID-19 / prevention & control*
  • Clinical Trials, Phase III as Topic
  • Female
  • Humans
  • Immunogenicity, Vaccine
  • Male
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • Spike Glycoprotein, Coronavirus / immunology
  • Vaccine Efficacy*
  • Young Adult

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Spike Glycoprotein, Coronavirus
  • spike protein, SARS-CoV-2
  • 2019-nCoV Vaccine mRNA-1273