Trial reportThe Journal of infectious diseases2024
Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults.
Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04528719 (A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
Who cites it
43 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.
- A Systematic Review of Clinical Trials Using mRNA Vaccines for Infectious Diseases other than COVID-19.British journal of biomedical science · 2025Pooled it
- Safety and immunogenicity of an mRNA COVID-19 vaccine administered to adults: A phase 2, randomized, active-controlled trial.Human vaccines & immunotherapeutics · 2026Trial
- 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.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months.Human vaccines & immunotherapeutics · 2025Trial
- Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial.Nature communications · 2025Trial
- High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302).Annals of internal medicine · 2025Trial
- Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study.Frontiers in immunology · 2025Trial
- Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults.The Journal of infectious diseases · 2024Trial
- Towards mRNA therapeutics 2.0.Nature reviews. Drug discovery · 2026Review
- Review
- A comprehensive look at Respiratory Syncytial Virus (RSV): from pathogenesis to prevention.Tropical diseases, travel medicine and vaccines · 2026Review
- Anti-RSV drug screening and inhibition of RSV infection by lapatinib through the IL-17 pathway.Antimicrobial agents and chemotherapy · 2026Article
- Delineating RSV-A and RSV-B: Epidemiological Patterns, Diagnostics, Clinical Severity, and Preventive Approaches.Journal of medical virology · 2026Review
- Vaccinations in patients with interstitial lung diseases: a narrative review.European respiratory review : an official journal of the European Respiratory Society · 2026Review
- Article
- Adult RSV Vaccination: What Is the Role of RSV Subgroup in Disease Prevention?Infectious diseases and therapy · 2026Review
- Efficacy and Safety of Messenger RNA Vaccines.Health science reports · 2026Article
- Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.Medicinal research reviews · 2026Review
- Maternal RSV immunization: clinical efficacy, immunological mechanisms and public health implications for preventing infant lower respiratory tract infection.Journal of health, population, and nutrition · 2026Review
- Respiratory syncytial virus (RSV) antibody and small-molecule drugs: current status of clinical translation and challenges.Frontiers in microbiology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundAn mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults.
methodsBased on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 in adults aged 65 to 79 years. Participants were randomized to receive 1 dose of mRNA-1345 (12.5, 25, 50, 100, or 200 µg) or placebo and matched mRNA-1345 booster or placebo at 12 months.
resultsOverall, 298 participants received the first injection and 247 received the 12-month booster injection. mRNA-1345 was generally well tolerated after both injections, with the most frequently reported solicited adverse reactions being injection site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection but with severity, time to onset, and duration similar to the first injection. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers and prefusion F binding antibody (preF bAb) concentrations at 1 month (geometric mean fold rises: RSV-A, 10.2-16.5; RSV-B, 5.3-12.5; preF bAb, 7.2-12.1). RSV antibody levels remained above baseline through 12 months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B neutralizing antibody titers and preF bAb concentrations; titers after booster injection were numerically lower than those after the first dose, with overlapping 95% CIs.
conclusionsmRNA-1345 was well tolerated and immunogenic following a single injection and a 12-month booster. CLINICAL TRIALS REGISTRATION: NCT04528719 (ClinicalTrials.gov).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.