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Randomized Controlled Trial
. 2025 Nov 3;46(41):4291-4298.
doi: 10.1093/eurheartj/ehaf679.

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  1   2 , Mats C Højbjerg Lassen  1   2 , Niklas Dyrby Johansen  1   2 , Sine H Christensen  1   2 , Negar Aliabadi  3 , Kristoffer G Skaarup  1   2 , Daniel Modin  1   2 , Brian L Claggett  4 , Carsten S Larsen  5   6 , Lykke Larsen  7 , Lothar Wiese  8 , Michael Dalager-Pedersen  9   10 , Matias G Lindholm  11 , Anne Marie R Jensen  1   2 , Maria Dons  1   2 , Katrine F Bernholm  1   2 , Filip S Davidovski  1   2 , Lisa S Duus  1   2 , Camilla I Ottosen  1   2 , Anne B Nielsen  1   2 , Julie H Borchsenius  1   2 , Caroline Espersen  1   2 , Güldas Köse  1   2 , Frederik H Fussing  1   2 , Lars Køber  12   13 , Scott D Solomon  4 , Jens Ulrik Stæhr Jensen  12   14 , Cyril Jean-Marie Martel  15 , Bradford D Gessner  3 , Claudia Schwarz  3 , Elisa Gonzalez  3 , Mette Skovdal  3 , Pingping Zhang  3 , Elizabeth Begier  3 , Tor Biering-Sørensen  1   2   13   16
Affiliations
Randomized Controlled Trial

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 et al. Eur Heart J. .

Abstract

Background and aims: It 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.

Methods: We 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.

Results: The 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).

Conclusions: 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.

Keywords: Atherosclerosis; Cardiovascular diseases; Randomized controlled trial; Registries; Respiratory syncytial virus; Vaccination.

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Figures

Structured Graphical Abstract
Structured Graphical Abstract
Summary of the effectiveness of an RSVpreF vaccine against respiratory and CV outcomes among persons with and without ASCVD. Created in BioRender®.
Figure 1
Figure 1
Number of events, incidence rates, absolute risk reductions, and vaccine effectiveness in DAN-RSV participants with and without a history of atherosclerotic cardiovascular disease. ARR, absolute risk reduction; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; DAN-RSV, A Pragmatic Randomized Trial to Evaluate Bivalent RSV Prefusion F Protein–based Vaccine Effectiveness for Preventing RSV Hospitalizations in Adults Aged 60 Years or Above; N/A, not applicable (unable to calculate due to lack of events in the ASCVD subgroup); PY, participant-years; RSV, respiratory syncytial virus; RSVpreF vaccine, respiratory syncytial virus prefusion F protein-based vaccine; VE, vaccine effectiveness
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