Trial reportThe Journal of infectious diseases2024
Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 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 NCT04732871 (A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above), which is not on this map. Cited by 28 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 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Real-World Effectiveness of RSVpreF and RSVpreF3 Vaccines in Preventing Hospitalization and Emergency Department Visits Associated With Respiratory Syncytial Virus in Older Adults: A Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Pooled it
- A first-in-human Phase 1/1b randomized trial evaluating the safety and immunogenicity of a respiratory syncytial virus (RSV) virus-like particle subunit vaccine (IVX-121) in healthy young and older adults.Human vaccines & immunotherapeutics · 2026Trial
- Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged ≥60 Years.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Immunogenicity and safety of a single dose of adjuvanted RSVPreF3 vaccine in adults ≥60 years of age in China: results from a phase 3 immunobridging trial.Frontiers in immunology · 2026Trial
- Immune persistence and safety of the AS01Human vaccines & immunotherapeutics · 2025Trial
- Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination.The Journal of infectious diseases · 2024Trial
- Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Exceeding expectations: factors contributing to the potency of human papillomavirus vaccines.The Lancet. Microbe · 2026Review
- AS01Drug safety · 2026Article
- Structural Advances in Respiratory Syncytial Virus: Implications for Vaccine and Antiviral Development.Microorganisms · 2026Review
- Immunogenicity and reactogenicity of the adjuvanted respiratory syncytial virus vaccine in patients with chronic kidney disease.Clinical kidney journal · 2026Article
- Advancing Vaccination Strategies for Older Adults: Insights of the Adult Immunization Board Meeting.Drugs & aging · 2026Review
- Aging and vaccines: impact of immunosenescence and inflammaging in vaccine response.Frontiers in aging · 2026Review
- The characterization of a rhamnosylated triterpenic saponin fromFrontiers in pharmacology · 2026Article
- Assessing the risk of Guillain-Barré syndrome in older adults after bivalent RSV pre-F vaccination in England.Nature communications · 2025Article
- Establishing long-lasting vaccine immunity: insights from mRNA and adjuvanted protein platforms.NPJ vaccines · 2025Review
- High seroprevalence and high risk: why are older adults more prone to respiratory syncytial virus?Journal of virology · 2025Review
- De-risking vaccine development: lessons, challenges, and prospects.NPJ vaccines · 2025Review
- Vaccine Development for Human Pneumoviruses.Vaccines · 2025Review
- Costs and Complications of Respiratory Syncytial Virus and Acute Respiratory Infections in the Adult Population: Analysis of a German Claims Database.PharmacoEconomics - open · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe recently approved AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) demonstrated high efficacy against RSV-related disease in ≥60-year-olds.
methodsThis ongoing phase 3 study in ≥60-year-olds evaluates immune persistence until 3 years after RSVPreF3 OA vaccination. Here, we describe interim results on humoral and cell-mediated immunogenicity, reactogenicity, and safety until 1 year post-dose 1.
resultsIn total, 1653 participants were vaccinated. One month post-dose 1, neutralization titers increased 10.5-fold (RSV-A) and 7.8-fold (RSV-B) vs pre-dose 1. Titers then declined to levels 4.4-fold (RSV-A) and 3.5-fold (RSV-B) above pre-dose 1 at month 6 and remained 3.1-fold (RSV-A) and 2.3-fold (RSV-B) above pre-dose 1 levels after 1 year. RSVPreF3-binding immunoglobulin G levels and CD4+ T-cell frequencies showed similar kinetics. Solicited administration-site and systemic adverse events (mostly mild to moderate and transient) were reported by 62.2% and 49.5% of participants. Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related.
conclusionsOne RSVPreF3 OA dose elicited cell-mediated and RSV-A- and RSV-B-specific humoral immune responses that declined over time but remained above pre-dose 1 levels for at least 1 year. The vaccine was well tolerated with an acceptable safety profile. Clinical Trials Registration. NCT04732871 (ClinicalTrials.gov).
Indexed as
Identifiers
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.