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

Author

Listed:
  • 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
    The Newcastle upon Tyne Hospitals NHS Foundation Trust)

  • 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)

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.

Suggested Citation

  • 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 , 2025. "Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial," Nature Communications, Nature, vol. 16(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-61153-x
    DOI: 10.1038/s41467-025-61153-x
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