Safety and Immunogenicity of an mRNA Respiratory Syncytial Virus Vaccine, mRNA-1345, in Healthy and High-Risk Pediatric Populations Aged 2 to 17 Years

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ID: 332665
2026
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Abstract
Abstract Background Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTI) in infants and children. No active RSV vaccine is currently available for children. mRNA-1345 is an investigational mRNA-based RSV vaccine encoding the prefusion F (preF) glycoprotein. Methods This phase 2, randomized, observer-blind study evaluated a single dose of mRNA-1345 in children aged 2 to <18 years who were healthy (2 to <5 years only) or had stable chronic conditions associated with increased RSV risk. Children aged 2 to <5 years received 7.5-, 15-, or 30-µg mRNA-1345 or placebo, whereas children aged 5 to <18 years received 15-, 30-, or 50-µg mRNA-1345. The primary objective was safety and reactogenicity (Part A); the secondary objective was immunogenicity. RSV surveillance was conducted from 6 to 12 months post-immunization in a subset of re-enrolled participants from the 2 to <5-year-old cohort (Part B). Results Overall, 346 participants received study vaccination. Across dose levels and age cohorts, mRNA-1345 was well tolerated, with no vaccine-related serious adverse events or discontinuations. mRNA-1345 elicited robust increases in RSV-A and RSV-B neutralizing antibody titers and preF-biased responses by Day 29. During Part B surveillance, RSV infections were infrequent, with no severe/hospitalized RSV-LRTIs. Conclusions mRNA-1345 demonstrated a favorable safety profile and was immunogenic in a predominantly RSV-seropositive pediatric population. These results support potential further clinical development of this vaccine in children aged >2 years at increased RSV risk, with further evaluation required to characterize the benefit-risk profile in RSV-naïve children.
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Authors Jennifer Moore, Hui Qian, Sonia Stoszek, Richard Bennett, Shelly David Senders, Scott P. Striplin, Jennifer Lynn Nayak, Matthew D. Snape
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Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag679
URL
https://doi.org/10.1093/ofid/ofag679
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