Evidence map›Paper›PMID 40960793›Full record

Trial reportJAMA cardiology2025

Prevention of Adverse Cardiovascular Events Using the 23-Valent Pneumococcal Polysaccharide Vaccine: A Randomized Clinical Trial.

Alexis Hure, Roseanne Peel, Catherine D'Este, Walter P Abhayaratna, Andrew Tonkin, Ingrid Hopper, Amanda G Thrift, Christopher Levi, Jonathan Sturm, David Durrheim and 10 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Alexis HureThe University of Newcastle, Callaghan, New South Wales, Australia.
Roseanne PeelThe University of Newcastle, Callaghan, New South Wales, Australia.
Catherine D'EsteThe Sax Institute, Glebe, New South Wales, Australia.
Walter P AbhayaratnaCanberra Hospital, Woden, Australian Capital Territory, Australia.
Andrew TonkinMonash University, Melbourne, Victoria, Australia.
Ingrid HopperMonash University, Melbourne, Victoria, Australia.
Amanda G ThriftSchool of Clinical Sciences at Monash Health, Department of Medicine, Monash University, Monash Medical Centre, Clayton, Victoria, Australia.
Christopher LeviDepartment of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.
Jonathan SturmThe University of Newcastle, Callaghan, New South Wales, Australia.
David DurrheimThe University of Newcastle, Callaghan, New South Wales, Australia.
Joseph HungMedical School, University of Western Australia, Nedlands, Western Australia, Australia.
Tom BriffaSchool of Population Health, University of Western Australia, Perth, Western Australia, Australia.
Derek P ChewSchool of Medicine, Victorian Heart Hospital, Victorian Heart Institute, Bedford Park, South Australia, Australia.
Shu RenThe University of Newcastle, Callaghan, New South Wales, Australia.
Mark McEvoyThe University of Newcastle, Callaghan, New South Wales, Australia.
Philip HansbroCentenary Institute, Sydney, New South Wales, Australia.
David NewbySchool of Biomedical Science and Pharmacy, The University of Newcastle-Callaghan Campus, Callaghan, New South Wales, Australia.
Stuart SzwecHunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
Simon ChiuCollege of Health, Medicine and Wellbeing, The University of Newcastle School of Medicine and Public Health, Callaghan, New South Wales, Australia.
John AttiaCentre for Clinical Epidemiology and Biostatistics, The University of Newcastle-Callaghan Campus, Callaghan, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Animal studies and meta-analysis of human observational data suggest that pneumococcal polysaccharide vaccination (PPV) could be protective against atherosclerosis; however, to the authors' knowledge, no randomized clinical trial has been conducted. Objective: To determine whether pneumococcal vaccination (Pneumovax [Merck Sharp & Dohme Corp]) decreases the composite primary outcome of fatal and nonfatal acute coronary syndrome and ischemic stroke in people at increased risk, with an average follow-up of 7 years after immunization. Design, Setting, and Participants: This was a double-blind, placebo-controlled, parallel-arm randomized clinical trial conducted at 6 centers across Australia. Participants were community-dwelling adults 55 to 60 years of age at baseline in 2016 to 2017, with at least 2 risk factors (obesity, hypertension, or hypercholesterolemia) for cardiovascular disease (CVD) but no prior CVD event or indication for early pneumococcal vaccination. Data were analyzed from February 2023 to December 2024 using competing risk proportional hazards regression models, stratified by sex and center. Interventions: Participants received either 23-valent PPV (PPV23) or placebo (saline). Main Outcomes and Measures: The primary outcome was a composite of fatal and nonfatal myocardial infarction or ischemic stroke, ascertained via electronic medical records from emergency department, admitted patient, and mortality data collections using International Statistical Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) codes. Results: A total of 4725 participants (mean [SD] age, 58.0 [1.7] years; 2433 male [52%]) were included in this study. There was no significant difference in the primary outcome (58 of 2366 events in the active PPV23 group compared with 64 of 2357 events in the control group, hazard ratio, 0.90; 95% CI, 0.63-1.28; P = .57). Similarly, no significant differences occurred in the exploratory outcomes of all-cause mortality, all-cause hospital presentations, and CVD-related hospital procedures. These results are tempered by the lower than expected event rate leading to low power. Conclusions and Relevance: Results of this randomized clinical trial found that PPV23 did not reduce the rates of fatal and nonfatal acute coronary syndrome and ischemic stroke, although the study was underpowered. Trial Registration: ANZCTR Identifier: ACTRN12615000536561.

Indexed as

Acute Coronary SyndromeCardiovascular DiseasesIschemic StrokeMyocardial InfarctionPneumococcal VaccinesAustraliaDouble-Blind MethodFemaleHumansMaleMiddle Aged23-valent pneumococcal capsular polysaccharide vaccinePneumococcal Vaccines

Identifiers

PMID40960793
PMCPMC12444640

What OpenQuestion holds

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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 OpenQuestion graph.