Trial reportThe Journal of infectious diseases2024
Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial.
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 21 papers, 2 of them syntheses 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
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A Systematic Review of Clinical Trials Using mRNA Vaccines for Infectious Diseases other than COVID-19.British journal of biomedical science · 2025Pooled it
- Recent advances on coxsackievirus A6 vaccine research.Frontiers in immunology · 2025Pooled it
- 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
- Anti-RSV drug screening and inhibition of RSV infection by lapatinib through the IL-17 pathway.Antimicrobial agents and chemotherapy · 2026Article
- Structural Advances in Respiratory Syncytial Virus: Implications for Vaccine and Antiviral Development.Microorganisms · 2026Review
- Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.Medicinal research reviews · 2026Review
- From bench to bedside: Unveiling the background and benefits of nanovaccines tested in clinics.Asian journal of pharmaceutical sciences · 2026Review
- RSV vaccine development: advances and fusion protein-focused strategies.Frontiers in immunology · 2026Review
- Establishing long-lasting vaccine immunity: insights from mRNA and adjuvanted protein platforms.NPJ vaccines · 2025Review
- Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Vaccine Development for Human Pneumoviruses.Vaccines · 2025Review
- Preventing RSV Infection in Children: Current Passive Immunizations and Vaccine Development.Pathogens (Basel, Switzerland) · 2025Review
- Article
- Respiratory syncytial virus: health burden, disease prevention, and treatment-recent progress and lessons learned.microLife · 2025Review
- Technological breakthroughs and advancements in the application of mRNA vaccines: a comprehensive exploration and future prospects.Frontiers in immunology · 2025Review
- Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.MedComm · 2024Review
- Progress and prospects of mRNA-based drugs in pre-clinical and clinical applications.Signal transduction and targeted therapy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundRespiratory syncytial virus (RSV) presents a global health concern. A lipid nanoparticle-encapsulated mRNA-based RSV vaccine (mRNA-1345) that encodes the membrane-anchored RSV prefusion-stabilized F glycoprotein is under clinical investigation.
methodsThis phase 1 dose escalation study was based on a randomized, observer-blind, placebo-controlled design, and it assessed the safety and immunogenicity of mRNA-1345 in healthy adults aged 18 to 49 years. Participants were randomized to receive 1 dose of mRNA-1345 (50, 100, or 200 µg) or placebo or 3 doses of mRNA-1345 (100 µg) or placebo 56 days apart.
resultsmRNA-1345 was well tolerated at all dose levels. The most common solicited adverse reactions were pain, headache, fatigue, myalgia, or chills, which were all generally mild to moderate. At 1 month postinjection, a single injection of mRNA-1345 boosted RSV neutralizing antibody titers (geometric mean fold rise: RSV-A, 20.0-23.5; RSV-B, 11.7-16.0) and RSV prefusion binding antibody concentrations (geometric mean fold rise, 16.1-21.8), with no apparent dose response. Antibody levels remained above baseline through 6 months. Sequential doses of 100 µg were well tolerated but did not further boost antibody levels.
conclusionsA single mRNA-1345 injection demonstrated an acceptable safety profile in younger adults and induced a durable neutralizing antibody response, supporting its continued development. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT04528719.
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What OpenQuestion holds
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.