Trial reportThe Journal of infectious diseases2022
Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine.
Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03529773 (A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS), which is not on this map. Cited by 53 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 1/2, placebo-controlled, randomized, observer-blind, dose-finding, first-in-human study to describe the safety, tolerability, and immunogenicity of a respiratory syncytial virus (rsv) vaccine in healthy adults
Who cites it
53 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.
- Safety and Efficacy of Respiratory Syncytial Virus Vaccination in Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials.JMIR public health and surveillance · 2025Pooled it
- Coadministration of mRNA-1345 RSV vaccine with high-dose quadrivalent influenza vaccine in adults aged 65 and older: An observer-blinded, placebo-controlled, randomized, phase 3 trial.Human vaccines & immunotherapeutics · 2026Trial
- Dynamics of Respiratory Syncytial Virus Illness and Serology During Pregnancy and Infancy in the United States and South Africa.Open forum infectious diseases · 2025Trial
- Bivalent RSVpreF Vaccine in Adults 18 to <60 Years Old With High-Risk Conditions.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination.The Journal of infectious diseases · 2024Trial
- Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study.The Journal of infectious diseases · 2024Trial
- Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Safety and immunogenicity following co-administration of Yellow fever vaccine with Tick-borne encephalitis or Japanese encephalitis vaccines: Results from an open label, non-randomized clinical trial.PLoS neglected tropical diseases · 2023Trial
- A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults.The Journal of infectious diseases · 2022Trial
- Article
- Adult RSV Vaccination: What Is the Role of RSV Subgroup in Disease Prevention?Infectious diseases and therapy · 2026Review
- Immunogenicity of a Recombinant MVA Vector Vaccine Expressing the Prefusion RSV F Protein in Balb/c Mice.Vaccines · 2026Article
- Bivalent RSV prefusion F vaccination elicits effective neutralization of contemporary and monoclonal antibody-resistant RSV strains.NPJ vaccines · 2026Article
- Nirsevimab vs RSVpreF Vaccine for Respiratory Syncytial Virus-Related Hospitalization in Newborns.JAMA · 2026Article
- 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
- Safety and immunogenicity of bivalent RSVpreF vaccine formulated in a multidose vial in healthy female participants in the USA: a multicentre, randomised, open-label, noninferiority phase 3 study.EClinicalMedicine · 2026Article
- RSV Vaccines: Targeting Prefusion F and G Proteins from Structural Design to Clinical Application.Vaccines · 2025Review
- Delivery Systems of mRNA Vaccines in the Treatment of Infectious Diseases: From Lipid Nanoparticles to Next-Generation Platforms.Advanced pharmaceutical bulletin · 2025Review
- Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine.Vaccines · 2025Article
- Respiratory Syncytial Virus Humoral Antibody Responses in Older Adults After Vaccination or Infection.The Journal of infectious diseases · 2025Article
Corrections and comments
- Commented on by
Authors and funding
13 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRespiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults and adults with comorbidities. An effective vaccine is needed. An investigational bivalent prefusion F vaccine (RSVpreF) was assessed in healthy adults.
methodsThis phase 1/2 study randomized adults 18-85 years old to receive placebo or 60, 120, or 240 µg RSVpreF (with or without aluminum hydroxide) alone or concomitantly with seasonal inactivated influenza vaccine (SIIV). Safety and immunogenicity were assessed.
resultsIn older adults, reactogenicity events were predominantly mild or moderate among RSVpreF recipients; adverse events through 1 month postvaccination were similar across formulations. Coadministration with SIIV did not appear to affect safety among younger or older adults. All RSVpreF formulations with or without concomitant SIIV elicited robust RSV serum-neutralizing responses in adults aged 50-85 years 1 month postvaccination. Neutralizing titers 1 and 12 months postvaccination were 6.9-14.9 and 2.9-4.5 times, respectively, those before vaccination. SIIV immune responses trended lower when coadministered with RSVpreF.
conclusionsRSVpreF formulations administered alone or with SIIV were well tolerated and highly immunogenic in older adults, supporting the potential for RSVpreF to protect older adults from RSV disease. CLINICAL TRIALS REGISTRATION: NCT03529773.
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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.