Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial
By P. Gilbert, D. Montefiori, A. McDermott, Y. Fong, D. Benkeser, Wei-zhi Deng, Honghong Zhou, Christopher R. Houchens, Karen Martins, L. Jayashankar and 30 more. Science, 2021
977 citations recorded by the source corpus.
Description Antibody levels predict vaccine efficacy Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a molecular biomarker to measure how much immunity is needed to fight infection and is key for successful global immunization programs. Gilbert et al. determined that antibodies are the correlate of protection in vaccinated individuals enrolled in the Moderna COVE phase 3 clinical trial (see the Perspective by Openshaw). By measuring binding and neutralizing antibodies against the viral spike protein, the authors found that the levels of both antibodies correlated with the degree of vaccine efficacy. The higher the antibody level, the greater the protection afforded by the messenger RNA (mRNA) vaccine. Antibody levels that predict mRNA vaccine efficacy can therefore be used to guide vaccine regimen modifications and support regulatory approvals for a broader spectrum of the population. —PNK SARS-CoV-2 binding and neutralizing antibodies correlate with the degree of vaccine efficacy and protection for the Moderna mRNA COVID-19 vaccine. 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.
Subfields: Animal Science and Zoology, Immunology, Infectious Diseases
View Paper: https://www.semanticscholar.org/paper/5defb8687d19c0cfec0c8b9eb12a85fe625327d8
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Citations in the corpus
- The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic (2021, positive): “Neutralizing antibody responses are also believed to be critical for protection against COVID-19 by BNT vaccination (Corbett et al., 2021; Feng et al., 2021; Gilbert et al., 2021).”