Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial

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 bi...

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Published in:Nature communications Vol. 16; no. 1; pp. 6118 - 12
Main Authors: Ma, Chong, Du, Jiejun, Lan, Lan, Kapoor, Archana, Marc, Gonzalo Perez, Jimenez, Gilberto, Duncan, Christopher J. A., Le Cam, Nancy, Lin, Nina, Priddy, Frances, Garg, Sanjay, Stoszek, Sonia K., Shaw, Christine A., Goswami, Jaya, Wilson, Eleanor, Das, Rituparna, Zhou, Honghong, Zheng, Lingyi
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 03.07.2025
Nature Publishing Group
Nature Portfolio
Subjects:
13/1
631/250/255/2514
631/250/590/2293
Adult
Aged
Antibodies
Antibodies, Neutralizing - blood
Antibodies, Neutralizing - immunology
Antibodies, Viral - blood
Antibodies, Viral - immunology
Binding
Biomarkers
Correlation
Effectiveness
Female
Humanities and Social Sciences
Humans
Immunoglobulin G
Immunoglobulin G - blood
Immunoglobulin G - immunology
Male
Middle Aged
mRNA
mRNA Vaccines
multidisciplinary
Neutralizing
Older people
Respiratory diseases
Respiratory syncytial virus
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
Respiratory tract
Respiratory tract diseases
Science
Science (multidisciplinary)
Vaccine Efficacy
Vaccines
ISSN:2041-1723, 2041-1723
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Summary: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.
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ISSN:2041-1723
2041-1723
DOI:10.1038/s41467-025-61153-x