Evidence mapPaperPMID 40884439Full record

Trial reportEuropean heart journal2025

Effectiveness of bivalent respiratory syncytial virus prefusion F protein-based vaccine in individuals with or without atherosclerotic cardiovascular disease: the DAN-RSV trial.

Manan Pareek, Mats C Højbjerg Lassen, Niklas Dyrby Johansen, Sine H Christensen, Negar Aliabadi, Kristoffer G Skaarup, Daniel Modin, Brian L Claggett, Carsten S Larsen, Lykke Larsen and 25 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European heart journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. 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

35 authors.

Manan PareekDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0002-0867-5825
Mats C Højbjerg LassenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Niklas Dyrby JohansenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Sine H ChristensenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Negar AliabadiPfizer, New York, NY, USA.ORCID 0000-0002-9264-5089
Kristoffer G SkaarupDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Daniel ModinDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0002-7566-0519
Brian L ClaggettCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Carsten S LarsenDepartment of Clinical Medicine-Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Lykke LarsenResearch Unit for Infectious Diseases, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-4113-4182
Lothar WieseDepartment of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.ORCID 0000-0003-2719-1743
Michael Dalager-PedersenDepartment of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
Matias G LindholmDepartment of Cardiology, Zealand University Hospital, Roskilde, Denmark.
Anne Marie R JensenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Maria DonsDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Katrine F BernholmDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Filip S DavidovskiDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Lisa S DuusDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Camilla I OttosenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Anne B NielsenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Julie H BorchseniusDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Caroline EspersenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0003-2879-8862
Güldas KöseDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Frederik H FussingDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Lars KøberDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6635-1466
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Jens Ulrik Stæhr JensenDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Cyril Jean-Marie MartelEpidemiological Infectious Disease Preparedness, Statens Serum Institut, Copenhagen, Denmark.
Bradford D GessnerPfizer, New York, NY, USA.
Claudia SchwarzPfizer, New York, NY, USA.
Elisa GonzalezPfizer, New York, NY, USA.
Mette SkovdalPfizer, New York, NY, USA.
Pingping ZhangPfizer, New York, NY, USA.
Elizabeth BegierPfizer, New York, NY, USA.ORCID 0000-0002-1287-5416
Tor Biering-SørensenDepartment of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.ORCID 0000-0003-4209-2778

Funding

Pfizer Inc.
6 · The paper itself

Abstract

BACKGROUND AND

aimsIt is not known whether the bivalent respiratory syncytial virus prefusion F protein-based (RSVpreF) vaccine reduces outcomes in individuals with atherosclerotic cardiovascular disease (ASCVD). The aim was to evaluate the vaccine effectiveness (VE) of an RSVpreF vaccine vs no vaccine on respiratory and cardiovascular outcomes in persons with or without pre-existing ASCVD.

methodsWe conducted a prespecified secondary analysis of the DAN-RSV trial. Adults aged ≥60 years were randomized 1:1 to RSVpreF vaccine or no vaccine. Baseline and outcome data were collected through nationwide registries. The primary outcome was respiratory syncytial virus-related respiratory tract disease hospitalization. The principal major adverse cardiovascular event outcome was a composite of hospitalization for myocardial infarction, stroke, or heart failure. Heterogeneity in VE was assessed among participants with and without ASCVD.

resultsThe incidence rate of almost all outcomes was higher in participants with pre-existing ASCVD (n = 14 241) vs those without (n = 117 035). Vaccine effectiveness was generally consistent by ASCVD status (Pinteraction ≥ .05 for all but one interaction). Among persons without and with ASCVD, VE for the primary outcome was 80.0% [95% confidence interval (CI), 29.3-96.3] vs 100.0% (95% CI, -141.3 to 100.0), respectively (Pinteraction > .99). Vaccine effectiveness for major adverse cardiovascular events was 9.3% (95% CI, -15.1 to 28.6) in participants without, and 12.0% (95% CI, -34.6 to 43.3) in participants with, pre-existing ASCVD (Pinteraction = .90).

conclusionsThe VE of an RSVpreF vaccine vs no vaccine against respiratory and cardiovascular outcomes was similar among individuals ≥ 60 years of age with pre-existing ASCVD as compared with those without.

Indexed as

AtherosclerosisRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAgedCardiovascular DiseasesFemaleHospitalizationHumansMaleMiddle AgedRespiratory Syncytial Virus, HumanSecondary Data AnalysisVaccine EfficacyRespiratory Syncytial Virus VaccinesAtherosclerosisCardiovascular diseasesRandomized controlled trialRegistriesRespiratory syncytial virusVaccination

Identifiers

PMID40884439
PMCPMC12579979

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

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 Socratic graph.