Effectiveness of bivalent respiratory syncytial virus prefusion F protein-based vaccine in individuals with or without atherosclerotic cardiovascular disease: the DAN-RSV trial
Authors' conclusion
The 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.
Study context
- Population
- Adults aged ≥60 years with or without pre-existing atherosclerotic CVD (atherosclerotic cardiovascular disease (ASCVD))
- Comparison
- RSVpreF vaccine vs no vaccine, by ASCVD status
- Primary endpoint
- RSV-related respiratory tract disease hospitalization
Methodological detailsprespecified secondary analysis, 1:1 randomisation, registry-based data collection
- Prespecified secondary analysis
- 1:1 randomisation
- Registry-based data collection
Primary result
As reported in the abstract
RSV-related respiratory tract disease hospitalisation, VE by ASCVD status (subgroup analysis)
Vaccine effectiveness (VE), primary outcome, without ASCVD
80.0%
95% CI 29.3–96.3
VE, primary outcome, with ASCVD
100.0%
95% CI −141.3 to 100.0
VE, MACE, without ASCVD
9.3%
95% CI −15.1 to 28.6
VE, MACE, with ASCVD
12.0%
95% CI −34.6 to 43.3
Further findings
| Outcome | VE (95% CI) |
|---|---|
| MACE (hospitalization for MI, stroke or HF), by ASCVD status (subgroups)RSVpreF vaccine vs No vaccine · without ASCVD | 9.3% (−15.1 to 28.6) |
| MACE (hospitalization for MI, stroke or HF), by ASCVD status (subgroups)RSVpreF vaccine vs No vaccine · with ASCVD | 12.0% (−34.6 to 43.3) |
- MACE (hospitalization for MI, stroke or HF), by ASCVD status (subgroups): Pinteraction = .90
VE across outcomes by ASCVD status
- VE generally consistent by ASCVD status
- P for interaction ≥ 0.05 for all but one interaction
- Incidence rate of almost all outcomes higher with pre-existing ASCVD
Original publication
Effectiveness of bivalent respiratory syncytial virus prefusion F protein-based vaccine in individuals with or without atherosclerotic cardiovascular disease: the DAN-RSV trial. Eur Heart J. Published 30 August 2025. doi:10.
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