ArticleThe Journal of infectious diseases2024
Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study.
Article 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 NCT04657198 (A Phase 2b, Open-label, Multi-center, Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 Older Adults), which is not on this map. Cited by 14 papers.
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 2b, Open-label, Multi-center, Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 Older Adults (OA) Investigational Vaccine Administered Intramuscularly 18 Months Post-Dose 2 in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
Who cites it
14 citing papers in PubMed, 21 citations in OpenAlex.
- Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- AS01Drug safety · 2026Article
- Enhanced Th1 Cellular Immunity Induced by an RSV-F mRNA Vaccine Rationally Designed Using NLP Algorithms.Vaccines · 2026Article
- New Tools Against Old Enemies: Respiratory Syncytial Virus (RSV) in Older Adults. A Narrative Review.Farmaceuticos comunitarios · 2026Article
- Structural vaccinology expedites rational design of next-generation vaccines for influenza and respiratory syncytial virus.Virologica Sinica · 2026Review
- A Novel Unadjuvanted Subunit Respiratory Syncytial Virus Prefusion F Vaccine Induces Potent and Differentiated Functional Immune Responses Compared to AS01-Adjuvanted Arexvy in Older Adults.Open forum infectious diseases · 2026Article
- Vaccination in Patients with Cardiovascular Disease: A Case-Based Approach and Contemporary Review.CJC open · 2025Review
- A foldon-free prefusion F trimer vaccine for respiratory syncytial virus to reduce off-target immune responses.Nature microbiology · 2024Article
- Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.MedComm · 2024Review
- Review
- A self-amplifying RNA RSV prefusion-F vaccine elicits potent immunity in pre-exposed and naïve non-human primates.Nature communications · 2024Article
- Article
- Protecting our future: call for respiratory syncytial virus vaccine trial in infants.Annals of medicine and surgery (2012) · 2024Article
- Review
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundIn the previous (parent) study, 2 doses of different formulations of an investigational vaccine against respiratory syncytial virus (RSVPreF3 OA) were well tolerated and immunogenic in older adults. This multicenter phase 2b extension study assessed safety and immunogenicity of a revaccination (third) dose of the 120 μg RSVPreF3-AS01E formulation.
methodsIn total, 122 older adults (60-80 years), previously vaccinated with 2 doses of RSVPreF3-AS01E formulations (containing 30, 60, or 120 μg RSVPreF3 antigen), received an additional 120 μg RSVPreF3-AS01E dose 18 months after dose 2. Vaccine safety was evaluated in all participants up to 6 months and immunogenicity in participants who received 120 μg RSVPreF3-AS01E doses until 1 month after dose 3.
resultsSimilar to the parent study, mostly mild-to-moderate solicited adverse events and no vaccine-related serious adverse events or potential immune-mediated disorders were reported. Neutralizing titers and cell-mediated immune responses persisted for 18 months after 2-dose vaccination. Dose 3 increased RSV-specific neutralizing titers against RSV-A and RSV-B and median CD4+ T-cell frequencies. After dose 3, RSV-specific neutralizing titers but not CD4+ T-cell frequencies were below levels detected 1 month after dose 1.
conclusionsRevaccination with 120 μg RSVPreF3-AS01E 18 months after dose 2 is well tolerated and immunogenic in older adults. CLINICAL TRIALS REGISTRATION: NCT04657198; EudraCT, 2020-000692-21.
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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.