Effectiveness of bivalent respiratory syncytial virus prefusion F protein-based vaccine in individuals with or without atherosclerotic cardiovascular disease: the DAN-RSV trial
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 117 participants or records.
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