Evidence map›Paper›PMID 42172919›Full record

Trial reportEBioMedicine2026

Estimated efficacy of the adjuvanted RSVPreF3 vaccine against diverse and worldwide predominant RSV strains, irrespective of RSV F protein variation: results of a post-hoc analysis from the AReSVi-006 trial.

Jonathan De Smedt, Olivier Gruselle, Lionel Sacconnay, Delphine Baup, Christophe Lambert, Stebin Xavier, Francesca Crudele, Aurélie Olivier, Yannick Vanloubbeeck, Marie Van der Wielen and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04886596 (A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT04886596 phase3completednot on this map

A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2024Enrolled26,675ConditionsRespiratory Syncytial Virus InfectionsArmsPlacebo, RSVPreF3 OA vaccine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
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

13 authors.

Jonathan De SmedtGSK, Rixensart, Belgium.
Olivier GruselleGSK, Wavre, Belgium.
Lionel SacconnayGSK, Rixensart, Belgium.
Delphine BaupGSK, Wavre, Belgium.
Christophe LambertGSK, Rixensart, Belgium.
Stebin XavierGSK, Bangalore, India.
Francesca CrudeleGSK, Siena, Italy.
Aurélie OlivierGSK, Wavre, Belgium.
Yannick VanloubbeeckGSK, Rixensart, Belgium.
Marie Van der WielenGSK, Wavre, Belgium.
Marie-Pierre DavidGSK, Wavre, Belgium.
Nancy DezutterGSK, Wavre, Belgium.
Lucile WarterGSK, Rixensart, Belgium. Electronic address: lucile.x.warter@gsk.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAll currently approved RSV vaccines/monoclonal antibodies target the prefusion conformation of the F protein (preF). Amino acid (aa) variations in RSV F are increasingly observed, though their impact on vaccine efficacy (VE) remains unknown. We characterised F sequences of isolates from the phase 3 efficacy trial (AReSVi-006; NCT04886596) of the AS01

methodsRSV F aa sequences associated with PCR-confirmed RSV-lower respiratory tract disease (LRTD)/acute respiratory illnesses (ARIs) in AReSVi-006 (in adults aged ≥ 60 years, over three RSV seasons) were characterised and compared to the RSVPreF3 sequence and F sequences reported in public databases during the same period. VE against predominant RSV F sequences was estimated (post-hoc analyses).

findingsWe identified 19 RSV-A and 27 RSV-B F sequences, differing with 6-25 aa from RSVPreF3; these were representative of worldwide circulating strains during the trial. Two RSV-A and three RSV-B sequences were associated with most RSV-LRTD/ARI cases. The distribution of cases between vaccinated and placebo groups and VE estimates were within similar ranges in each RSV season across the predominant sequences. The aa sequences with the smallest and largest numbers of mutations compared to RSVPreF3 were not consistently associated with the highest and lowest VE estimates against RSV-LRTD/ARI.

interpretationOur findings support the efficacy of adjuvanted RSVPreF3 across a broad set of RSV strains, representative of globally circulating strains. VE was maintained irrespective of distance to RSVPreF3 in terms of the number of aa variations.

fundingGSK.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesVaccine EfficacyViral Fusion ProteinsAntibodies, ViralFemaleHumansMiddle AgedAntibodies, ViralF protein, human respiratory syncytial virusRespiratory Syncytial Virus VaccinesViral Fusion ProteinsAdjuvanted RSVPreF3Genetic evolutionpreF conformationRSV F proteinSequence diversityVaccine efficacy

Identifiers

PMID42172919
PMCPMC13224123

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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.