TY - JOUR
T1 - Respiratory syncytial virus vaccination and risk of respiratory and cardiorespiratory hospitalization in adults with chronic kidney disease
T2 - a prespecified analysis of the DAN-RSV trial
AU - Duus, Lisa Steen
AU - Lassen, Mats Christian Højbjerg
AU - Johansen, Niklas D
AU - Højlund Christensen, Sine
AU - Skaarup, Kristoffer G
AU - Janstrup, Kira Hyldekær
AU - Modin, Daniel
AU - Claggett, Brian L
AU - Larsen, Carsten S
AU - Reimer Jensen, Anne Marie
AU - Dons, Maria
AU - Bernholm, Katrine F
AU - Davidovski, Filip S
AU - Ottosen, Camilla I
AU - Nielsen, Anne B
AU - Borchsenius, Julie H
AU - Espersen, Caroline
AU - Bartholdy, Katja Vu
AU - Köse, Güldas
AU - Fussing, Frederik H
AU - Larsen, Lykke
AU - Wiese, Lothar
AU - Dalager-Pedersen, Michael
AU - Lindholm, Matias G
AU - Køber, Lars
AU - Solomon, Scott D
AU - Rossing, Peter
AU - Hansen, Ditte
AU - Jensen, Jens Ulrik Stæhr
AU - Martel, Cyril Jean-Marie
AU - Schwarz, Claudia
AU - Gonzalez, Elisa
AU - Skovdal, Mette
AU - Zhang, Pingping
AU - Gessner, Bradford D
AU - Aliabadi, Negar
AU - Begier, Elizabeth
AU - Biering-Sørensen, Tor
N1 - © The Author(s) 2026. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2026/4/30
Y1 - 2026/4/30
N2 - 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.
AB - 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.
KW - Cardiorespiratory disease
KW - Chronic kidney disease
KW - Pragmatic
KW - Respiratory syncytial virus (RSV)
U2 - 10.1093/eurjpc/zwag200
DO - 10.1093/eurjpc/zwag200
M3 - Article
C2 - 42059359
SN - 2047-4873
JO - European Journal of Preventive Cardiology
JF - European Journal of Preventive Cardiology
ER -