![]() Data points are from baseline-negative per-protocol vaccine recipients in the day 29 marker or day 57 marker case-cohort set. ( B) Pseudovirus neutralization ID50 titer. The last COVID-19 end point within the blinded phase occurred 100 days after day 57. Cases for day 57 marker correlates analyses (post–day 57 cases) are baseline SARS-CoV-2–negative per-protocol vaccine recipients with the symptomatic infection COVID-19 primary end point diagnosed starting 7 days after day 57 through the end of the blinded phase. *Cases for day 29 marker correlates analyses (intercurrent cases + post–day 57 cases) are baseline SARS-CoV-2–negative per-protocol vaccine recipients with the symptomatic infection COVID-19 primary end point diagnosed starting 7 days after day 29 through the end of the blinded phase. The N category under “COVID-19 cases” indicates either the number of vaccine breakthrough cases with day 1 and day 29 antibody marker data included (for day 29 marker analyses) or the number of vaccine breakthrough cases with day 1, day 29, and day 57 antibody data included (for day 57 marker analyses). ![]() The N category under “Noncases in immunogenicity subcohort” indicates the number of noncases in the immunogenicity subcohort and hence with day 1, day 29, and day 57 antibody marker data, included in both the day 29 and day 57 marker correlates analyses. Median (interquartile range) number of days from dose one to day 29 was 28 (28 to 30) and from day 29 to day 57 was 28 (28 to 30). Participant demographicsĪnalysis based on baseline-negative per-protocol vaccine recipients in the day 29 marker or day 57 marker case-cohort sets. Here, we assessed these same SARS-CoV-2 antibody markers as well as an 80% inhibitory dilution (ID 80) nAb titer as correlates of risk of COVID-19 and as correlates of mRNA-1273 vaccine protection against COVID-19 in the COVE trial. For the mRNA-1273 vaccine, multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody markers-including immunoglobulin G (IgG) bAbs to the spike protein, IgG bAbs to the spike receptor-binding domain (RBD), and 50% inhibitory dilution (ID 50) nAb titer-correlated with protection against SARS-CoV-2 replication after challenge in vaccinated rhesus macaques ( 24). The hypothesis that antibodies, whether elicited by infection or by spike protein–based vaccines, are a correlate of protection against COVID-19 is supported by diverse lines of evidence ( 13– 25). Neutralizing antibodies (nAbs) or binding antibodies (bAbs) have been established as a correlate of protection for vaccines against many viral diseases ( 11). The identification and validation of a correlate of protection would expedite the clinical evaluation and regulatory approval process for existing vaccines for new populations, for vaccine regimen modifications, and for new vaccines. Team, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team, and United States Government (USG)/CoVPN Biostatistics Team +41 authors +39 authors +34 authors fewer Authors Info & AffiliationsĬorrelates of protection, which are immunological markers that can be used to reliably predict the level of vaccine efficacy against a clinically relevant end point, such as COVID-19 ( 10– 12), are highly sought in vaccine research. Koup, Immune Assays Team, Moderna, Inc. Carpp, Rolando Pajon, Dean Follmann, Ruben O. Baden, Mira Baron, Luis De La Cruz, Cynthia Gay, Spyros Kalams, Colleen F. Hejazi, Chuong Huynh, Jacqueline Miller, Hana M. Lin, Sarah O’Connell, Charlene McDanal, Amanda Eaton, Marcella Sarzotti-Kelsoe, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. Houchens, Karen Martins, , Lakshmi Jayashankar, Flora Castellino, Britta Flach, Bob C. McDermott, Youyi Fong, , David Benkeser, Weiping Deng, Honghong Zhou, Christopher R. | series=Fairfax archive of glass plate negatives.Ĭitations are automatically generated and may require some modification to conform to exact standards.Peter B. | section=1 negative : glass, b&w 8.3 x 10.8 cm. | title= Edgar Berkeley Gifford, 4th Baron Gifford, shaking hands with dignitaries at the cutting of the ribbon of Sydney Harbour Bridge, Sydney, 19 March 1932 1932, Edgar Berkeley Gifford, 4th Baron Gifford, shaking hands with dignitaries at the cutting of the ribbon of Sydney Harbour Bridge, Sydney, 19 March 1932, viewed 26 March 2023 Wikipedia citation 26 March 2023 Harvard/Australian citationįairfax Corporation. ![]() Edgar Berkeley Gifford, 4th Baron Gifford, shaking hands with dignitaries at the cutting of the ribbon of Sydney Harbour Bridge, Sydney, 19 March 1932 :, 1932. Edgar Berkeley Gifford, 4th Baron Gifford, shaking hands with dignitaries at the cutting of the ribbon of Sydney Harbour Bridge, Sydney, 19 March 1932 Retrieved March 26, 2023, from MLA citationįairfax Corporation.
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