Trial reportThe Journal of infectious diseases2022
A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F 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 65 papers, 3 of them syntheses that pooled it.
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 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
65 citing papers in PubMed, 3 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- Aluminium adjuvants in vaccines and potential health effects: systematic review.BMJ (Clinical research ed.) · 2026Pooled it
- 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
- Efficacy, immunogenicity and safety of respiratory syncytial virus prefusion F vaccine: systematic review and meta-analysis.BMC public health · 2024Pooled it
- 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, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial.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, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study.The Journal of infectious diseases · 2024Trial
- Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial.The Journal of infectious 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
- Bivalent RSV prefusion F vaccination elicits effective neutralization of contemporary and monoclonal antibody-resistant RSV strains.NPJ vaccines · 2026Article
- Effectiveness of Maternal Respiratory Syncytial Virus Vaccination in Conferring Infant Immunity: Review and Future Perspectives.Vaccines · 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
- Corrected and republished from: "Clinical validation of an RSV neutralization assay and analysis of cross-sectional sera associated with 2021-2023 RSV outbreaks to investigate the immunity debt hypothesis".Microbiology spectrum · 2026Article
- 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
- Bivalent RSVpreF Subunit Vaccine Safety and Immunogenicity in Seropositive 2-<18 Year Olds.Vaccines · 2026Article
- Comparison of the protective effect of human respiratory syncytial virus Pre-F protein combined with different adjuvants in BALB/c mice.Frontiers in immunology · 2026Article
- Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV.Vaccines · 2025Article
- Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine.Vaccines · 2025Article
5 more citing papers are in PubMed but not listed here.
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
backgroundProtection against human respiratory syncytial virus (RSV) remains an unmet need potentially addressable by maternal immunization. This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.
methodsAdults 18-49 years old (N = 618) were randomized to receive placebo or 60, 120, or 240 µg RSVpreF with or without Al(OH)3. Safety and immunogenicity were evaluated.
resultsRSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. No vaccine-related serious adverse events occurred through 12 months postvaccination. All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated with protection of high-risk infants by palivizumab, the only prophylactic currently available for RSV. Geometric mean fold rises (GMFRs) across RSVpreF doses/formulations were 10.6-16.9 for RSV A and 10.3-19.8 for RSV B at 1 month postvaccination, greater than those historically elicited by postfusion F vaccines. GMFRs were 3.9-5.2 and 3.7-5.1, respectively, at 12 months postvaccination.
conclusionsRSVpreF formulations were safe, well tolerated, and induced robust neutralizing responses in adults. These findings support development of RSVpreF, which is being evaluated in a pivotal phase 3 study for maternal immunization. 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.