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Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial
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Journal Article
Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial
2025
Overview
Identifying an immunologic marker as a correlate of protection (CoP) for RSV vaccination is important. In the pivotal phase 3 trial, the mRNA-1345 vaccine demonstrated efficacy against RSV in older adults (NCT05127434). Here, we evaluate neutralizing antibodies (nAb) against RSV-A and -B, and IgG binding antibodies (bAb) to RSV fusion antigens as correlates of risk (CoR) and CoP against the pivotal trial’s efficacy endpoints of RSV lower respiratory tract disease with ≥2 or ≥3 signs/symptoms (RSV-LRTD-2+ and −3 + ) and acute respiratory disease (RSV-ARD). Day 29 RSV nAb and prefusion (preF) IgG demonstrate consistent inverse correlates with RSV endpoint occurrence. Day 29 point estimates (95% CIs) of the hazard ratio of each endpoint (RSV-LRTD-2 + , RSV-LRTD-3 + , RSV-ARD) per 10-fold increase in RSV-A nAb are 0.44 (0.30-0.65), 0.41 (0.20-0.84), and 0.45 (0.28-0.71), respectively, similar to RSV-B nAb and preF IgG. These results demonstrate Day 29 RSV nAb and preF IgG are CoRs and support their role as CoPs against RSV endpoints.
Identifying an immunologic marker as a correlate of protection (CoP) for RSV vaccination is important. Here, the authors demonstrate RSV neutralizing antibodies and RSV prefusion IgG binding antibodies as CoP for mRNA vaccination against RSV disease.
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ Adult
/ Aged
/ Antibodies, Neutralizing - blood
/ Antibodies, Neutralizing - immunology
/ Antibodies, Viral - immunology
/ Binding
/ Female
/ Humanities and Social Sciences
/ Humans
/ Immunoglobulin G - immunology
/ Male
/ mRNA
/ Respiratory Syncytial Virus Infections - immunology
/ Respiratory Syncytial Virus Infections - prevention & control
/ Respiratory Syncytial Virus Infections - virology
/ Respiratory Syncytial Virus Vaccines - administration & dosage
/ Respiratory Syncytial Virus Vaccines - immunology
/ Respiratory Syncytial Virus, Human - immunology
/ Science
/ Vaccines
