Respiratory syncytial virus vaccination and risk of respiratory and cardiorespiratory hospitalization in adults with chronic kidney disease: a prespecified analysis of the DAN-RSV trial.

AIMS: Respiratory syncytial virus (RSV) is a common cause of severe illness in older adults and may cause extra-pulmonary complications. Individuals with chronic kidney disease (CKD) are at increased risk of severe outcomes from respiratory infections, but RSV-specific data are limited. This prespecified analysis of the DAN-RSV trial evaluated the RSV prefusion F protein-based vaccine (RSVpreF) effectiveness (VE) in adults aged ≥60 years with and without CKD. METHODS AND RESULTS: The DAN-RSV trial was a pragmatic, open-label, parallel-group, individually randomized clinical trial conducted during 2024/25. Adults aged ≥60 years were randomized 1:1 to receive respiratory syncytial virus prefusion F (RSVpreF) or no vaccine. Chronic kidney disease was identified using diagnosis codes and biomarkers. Outcomes were assessed through nationwide registry linkage from 14 days post-randomization to 31 May 2025. The primary outcome was RSV-related respiratory tract disease hospitalization; secondary outcomes included respiratory, cardiovascular, and kidney-related hospitalizations, and all-cause mortality. Among 131 276 participants (65 642 RSVpreF; 65 634 controls), 13 364 (10.2%) had CKD. Chronic kidney disease participants were older and had more comorbidities. Hospitalization rates were consistently higher among those with CKD. RSVpreF compared with no vaccine reduced RSV-related respiratory tract disease hospitalization [overall VE: 83.3% (95% confidence interval, CI: 42.9-96.9%); CKD VE: 66.4% (95% CI: -85.2 to 96.7%); no CKD VE: 91.7% (95% CI: 43.7 to99.8%), Pinteraction = 0.29], and cardiorespiratory hospitalization, irrespective of CKD status. Among participants with CKD, a numerical imbalance in mortality was observed; however, event numbers were limited. CONCLUSION: In this analysis of the DAN-RSV trial, RSVpreF vaccination reduced RSV-related, broader respiratory and cardiorespiratory hospitalizations in older including those with CKD. No significant differences were observed for acute kidney outcomes.