Key result
RSVpreF vaccine cuts RSV hospitalizations similarly in older adults with and without ASCVD.
Why the study?
Does the bivalent RSVpreF vaccine reduce RSV-related hospitalization and major adverse cardiovascular events in adults aged ≥60 years with or without ASCVD?
RCT (n=131,276)
1:1
Yes
Does the bivalent RSVpreF vaccine reduce RSV-related hospitalization and major adverse cardiovascular events in adults aged ≥60 years with or without ASCVD?
Effect estimate: VE 80.0% (without ASCVD) vs 100.0% (with ASCVD) (95% CI 29.3-96.3 vs -141.3 to 100.0)
p-value: p=>.99 for interaction
The RSVpreF vaccine demonstrates consistent effectiveness against respiratory and cardiovascular outcomes in older adults regardless of underlying atherosclerotic cardiovascular disease.
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. 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. 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). 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.
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Pareek et al. (2025) conducted an RCT in Atherosclerotic cardiovascular disease (ASCVD) (n=131,276). Bivalent respiratory syncytial virus prefusion F protein-based (RSVpreF) vaccine vs. No vaccine was evaluated on Respiratory syncytial virus-related respiratory tract disease hospitalization (VE 80.0% (without ASCVD) vs 100.0% (with ASCVD), 95% CI 29.3-96.3 vs -141.3 to 100.0, p=>.99 for interaction). The RSVpreF vaccine demonstrated similar effectiveness against RSV-related respiratory hospitalization in adults ≥60 years with (VE 100.0%) and without (VE 80.0%) pre-existing ASCVD.
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