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

Chong Ma, Jiejun Du, Lan Lan, Archana Kapoor, Gonzalo Perez Marc, Gilberto Jimenez, Christopher J. A. Duncan, Nancy Cam, Nina Lin, Frances Priddy, Sanjay Garg, Sonia K. Stoszek, Christine A. Shaw, Jaya Goswami, Eleanor Wilson, Rituparna Das, Honghong Zhou and Lingyi Zheng ()
Additional contact information
Chong Ma: Moderna Inc
Jiejun Du: Moderna Inc
Lan Lan: Moderna Inc
Archana Kapoor: Moderna Inc
Gonzalo Perez Marc: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Gilberto Jimenez: Spotlight Research Center LLC
Christopher J. A. Duncan: Newcastle University
Nancy Cam: Moderna Inc
Nina Lin: Moderna Inc
Frances Priddy: Moderna Inc
Sanjay Garg: Moderna Inc
Sonia K. Stoszek: Moderna Inc
Christine A. Shaw: Moderna Inc
Jaya Goswami: Moderna Inc
Eleanor Wilson: Moderna Inc
Rituparna Das: Moderna Inc
Honghong Zhou: Moderna Inc
Lingyi Zheng: Moderna Inc

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-61153-x

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