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Lookup NU author(s): Dr Christopher DuncanORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Identifying an immunologic marker as a correlate of protection (CoP) for RSV vaccination is important. In an mRNA-1345 RSV vaccine phase 3 efficacy trial in older adults (NCT05127434), neutralizing antibodies (nAb) against RSV-A and -B subtypes, and IgG binding antibodies (bAb) to RSV fusion antigens, were studied as correlates of risk (CoR) and CoP against 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 demonstrated 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 were 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 demonstrated Day 29 RSV nAb and preF IgG are CoRs and supported as CoPs against RSV endpoints.
Author(s): Ma C, Du J, Lan L, Kapoor A, Gonzalo Perez M, Jimenez G, Duncan CJA, Le Cam N, Lin N, Priddy F, Garg S, Stoszek SK, Shaw CA, Goswami J, Wilson E, Das R, Zhou H, Zheng L
Publication type: Article
Publication status: Published
Journal: Nature Communications
Year: 2025
Volume: 16
Online publication date: 03/07/2025
Acceptance date: 13/06/2025
Date deposited: 18/06/2025
ISSN (electronic): 2041-1723
Publisher: Nature Publishing Group
URL: https://doi.org/10.1038/s41467-025-61153-x
DOI: 10.1038/s41467-025-61153-x
Data Access Statement: As the trial is ongoing, access to patient-level data presented in this article and supporting clinical documents by qualified external researchers who provide methodologically sound scientific proposals may be available upon reasonable request for products or indications that have been approved by regulators in the relevant markets, and subject to review from 24 months after study completion. Such requests can be made to Moderna Inc., 325 Binney Street, Cambridge, MA 02142 «data_sharing@modernatx.com». A materials transfer and/or data access agreement with the sponsor will be required for accessing shared data. All other relevant data are presented in or provided with the paper. The figshare link for source data is: https://doi.org/10.6084/m9.figshare.29119217. The protocol is available online: Wilson et al.15.
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