Evidence map›Paper›PMID 38606958›Full record

Trial reportThe Journal of infectious diseases2024

Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination.

Edward E Walsh, Ann R Falsey, Agnieszka M Zareba, Qin Jiang, Alejandra Gurtman, David Radley, Emily Gomme, David Cooper, Kathrin U Jansen, William C Gruber and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

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 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
4.6field-weighted citation impact, top 5% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03529773 phase2completednot on this map

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

TypeinterventionalSponsorPfizerRan2018 to 2020Enrolled1,235ConditionsRespiratory Tract InfectionsArmsFormulation A, Formulation B, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. The recent landscape of RSV vaccine research.Therapeutic advances in vaccines and immunotherapy · 2025
    Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 2 countries.

Edward E WalshInfectious Diseases Division, Department of Medicine, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York.
Ann R FalseyInfectious Diseases Division, Department of Medicine, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York.
Agnieszka M ZarebaVaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
Qin JiangVaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
Alejandra GurtmanVaccine Research and Development, Pfizer Inc, Pearl River, New York.
David RadleyVaccine Research and Development, Pfizer Inc, Pearl River, New York.
Emily GommeVaccine Research and Development, Pfizer Inc, Pearl River, New York.
David CooperVaccine Research and Development, Pfizer Inc, Pearl River, New York.
Kathrin U JansenVaccine Research and Development, Pfizer Inc, Pearl River, New York.
William C GruberVaccine Research and Development, Pfizer Inc, Pearl River, New York.
Kena A SwansonVaccine Research and Development, Pfizer Inc, Pearl River, New York.
Beate Schmoele-ThomaVaccine Research and Development, Pfizer Pharma GmbH, Berlin, Germany.
Pfizer (United States) · USPfizer (Germany) · DERochester General Hospital · USUniversity of Rochester Medical Center · US

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study.

methodsHealthy adults were randomized to receive initial vaccination and revaccination 12 months later with either placebo or RSVpreF (240 µg with or without aluminum hydroxide). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability and safety were assessed.

resultsThere were 263 participants revaccinated (18-49 years old, n = 134; 65-85 years old, n = 129). Among 18- to 49-year-olds and 65- to 85-year-olds, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A, RSV-B) 1 month after initial RSVpreF vaccination were 13.3 to 20.4 and 8.9 to 15.5, respectively, as compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1 to 5.0 and 2.6 to 4.1. GMFRs 1 month after revaccination vs levels before revaccination were 1.4 to 2.3 and 1.4 to 2.2 for 18- to 49-year-olds and 65- to 85-year-olds. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7 to 1.6. No safety signals occurred.

conclusionsRSVpreF revaccination was immunogenic and well tolerated among adults. Clinical Trials Registration. NCT03529773 (ClinicalTrials.gov).

Indexed as

Antibodies, NeutralizingAntibodies, ViralImmunization, SecondaryRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAdolescentAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedVaccinationViral Fusion ProteinsAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesViral Fusion Proteinsimmunogenicityneutralizing responsesrespiratory syncytial virusRSVpreFsafetyvaccine

Identifiers

PMID38606958
PMCPMC11481295
OpenAlexW4394761165

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.