Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345, an mRNA Vaccine Against Respiratory Syncytial Virus, Administered 12 Months Following a Primary Dose in Adults Aged ≥50 Years.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05330975 (A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age
Who cites it
6 citing papers in PubMed.
- Transgene sequence codon optimization and composition determines replication competence of self-amplifying RNA.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Epitope-Based Nipah Virus G and F Head-to-Head Dimer mRNA Vaccines Exhibit Distinct Immunogenicity and Immune Profiles.Vaccines · 2026Article
- Adult RSV Vaccination: What Is the Role of RSV Subgroup in Disease Prevention?Infectious diseases and therapy · 2026Review
- RNA Therapeutics in Viral Infections and Cancer: Mechanisms, Challenges, and Prospects: A Review.Pharmaceutics · 2026Review
- Review
- mRNA vaccine platforms and novel delivery systems: From mechanistic principles to clinical translation.Human vaccines & immunotherapeutics · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
backgroundmRNA-1345 is a respiratory syncytial virus (RSV) vaccine approved for prevention of RSV-associated lower respiratory tract disease in individuals ≥ 60 years. Durability of efficacy is being evaluated in clinical trials. Data on revaccination in adults are needed.
methodsThis open-label, phase 3 trial evaluated revaccination with 50 µg mRNA-1345 administered 12 months after primary vaccination in participants aged ≥50 years. The primary objectives were the immunogenicity (RSV-A and RSV-B neutralizing antibody [nAb] responses), tolerability, and safety of revaccination.
resultsOverall, 543 participants were revaccinated. Most adverse reactions were mild/moderate (median duration, 2 days), with no new safety concerns identified. Coprimary immunogenicity endpoints met prespecified noninferiority criteria based on Day 29 geometric mean titer ratios (GMRs; revaccination vs primary vaccination). At Day 29, nAb GMRs (95% confidence interval [CI]) were 1.08 (1.0-1.17) for RSV-A and 0.91 (.84-.98) for RSV-B. Seroresponse rates (≥4-fold rise from baseline; 95% CI) at Day 29 were 77.5% (73.7-81.0) for RSV-A and 47.5% (43.2-51.9) for RSV-B, with a ≥2-fold rise in titers observed in 91.6% (88.9-93.8) and 69.8% (65.7-73.8) of participants, respectively. Following primary vaccination, RSV nAb titers increased by Day 29 and gradually declined over 12 months, yet remained above baseline levels. Revaccination at 12 months increased nAb titers, similar to the response observed after the primary dose.
conclusionsRevaccination of adults ≥ 50 years with mRNA-1345 was well tolerated, with a safety profile consistent with the primary dose. Respiratory syncytial virus nAb at Day 29 was noninferior to those after a primary mRNA-1345 dose, with antibody response persisting for 12 months. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT05330975.
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