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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).
BACKGROUND: The mRNA-1345 vaccine demonstrated efficacy against RSV disease with acceptable safety in adults >/=60 years in the ConquerRSV trial. Here, humoral immunogenicity results from the trial are presented. METHODS: This phase 2/3 trial randomly assigned adults (>/=60 years) to mRNA-1345 50-microg encoding prefusion F (preF) glycoprotein (n = 17,793) vaccine or placebo (n = 17,748). RSV-A and RSV-B neutralizing antibody (nAb) and preF binding antibody (bAb) levels at baseline and day 29 post-vaccination were assessed in a per-protocol immunogenicity subset ([PPIS]; mRNA-1345, n = 1515; placebo, n = 333). RESULTS: Day 29 nAb geometric mean titers (GMTs) increased 8.4-fold against RSV-A and 5.1-fold against RSV-B from baseline. Seroresponses (4-fold rise from baseline) in the mRNA-1345 groups were 74.2% and 56.5% for RSV-A and RSV-B, respectively. Baseline GMTs were lower among participants who met the seroresponse criteria than those who did not. mRNA-1345 induced preF bAbs at day 29, with a pattern similar to nAbs. Day 29 antibody responses across demographic and risk subgroups were generally consistent with the overall PPIS. CONCLUSION: mRNA-1345 enhanced RSV-A and RSV-B nAbs and preF bAbs in adults (>/=60 years) across various subgroups, including those at risk for severe disease, consistent with its demonstrated efficacy in the prevention of RSV disease.
Author(s): Goswami J, Baqui AH, Doreski PA, Perez Marc G, Jimenez G, Ahmed S, Zaman K, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Lan L, Du J, Kapoor A, Mehta S, Tomassini JE, Huang W, Zhou H, Stoszek SK, Priddy F, Lin N, Le Cam N, Shaw CA, Slobod K, Wilson E, Miller JM, Das R
Publication type: Article
Publication status: Published
Journal: The Journal of Infectious Diseases
Year: 2024
Volume: 230
Issue: 5
Pages: e996–e1006
Print publication date: 15/11/2024
Online publication date: 18/06/2024
Acceptance date: 17/06/2024
Date deposited: 25/04/2025
ISSN (print): 0022-1899
ISSN (electronic): 1537-6613
Publisher: Oxford University Press
URL: https://doi.org/10.1093/infdis/jiae316
DOI: 10.1093/infdis/jiae316
Data Access Statement: As the trial is ongoing, access to patient-level data and supporting clinical documents with qualified external researchers will be made available upon request and subject to review the trial completion date. A materials transfer and/or data access agreement with the sponsor will be required for accessing shared data. Such requests can be made to the corresponding author.
PubMed id: 38889247
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