Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12–59 months
Year: 2025
Type: article
Abstract: Respiratory syncytial virus (RSV) is a common respiratory pathogen in children. After demonstrating safety and immunogenicity in adults, mRNA-1345 encoding the RSV prefusion (preF) stabilized F glycoprotein was investigated in children. This phase 1, randomized, observer-blind study assessed the safety and immunogenicity of mRNA-1345 (NCT04528719) in RSV-seropositive children (per microneutralization assay) aged 12–59 months and is part of a larger study in multiple populations. Participants received three doses of mRNA-1345 (15 μg or 30 μg) or placebo 56 days apart, with 12-month safety follow-up. Forty-six participants were randomized to receive mRNA-1345 15 μg (n = 15), mRNA-1345 30 μg (n = 16), or placebo (n = 15). mRNA-1345 was well tolerated at both dose levels. The most frequently reported solicited local adverse reaction (AR) was injection site tenderness (15 μg, 27.3%–50.0%; 30 μg, 53.3%–71.4%; placebo, 26.7%–33.3%). Most solicited systemic ARs were grade 1/2, with irritability/crying, loss of appetite, and sleepiness most frequently reported; reactogenicity did not increase with additional doses. Throughout the 12-month follow-up, no serious adverse events (AEs), deaths, AEs of special interest, or AEs leading to study discontinuation were reported. Three medically attended RSV infections were reported among placebo recipients. A single injection increased RSV-A and RSV-B neutralizing antibody titers (geometric mean fold rise [GMFR] over baseline: 15 μg, RSV-A = 18.9, RSV-B = 7.2; 30 μg, RSV-A = 34.9, RSV-B = 14.3) and RSV preF and postF binding antibody concentrations (GMFR: 15 μg, preF = 13.9, postF = 9.3; 30 μg, preF = 26.5, postF = 16.0); binding antibody responses were preF-biased. Subsequent doses did not further increase antibody levels. In conclusion, mRNA-1345 was well tolerated and boosted antibody levels in seropositive children aged 12–59 months. ClinicalTrials.gov, NCT04528719
Source: Figshare
Authors: Sabine Schnyder Ghamloush, Sue Fanning, Brandon Essink, Frank Eder, Matthew D. Snape, Sonia K. Stoszek, Ruiting Guo, Rakesh Dhar, Vinicius Righi, Louie Morsy, Archana Kapoor, Laila El Asmar, Christine A. Shaw
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7084050560
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