Kidney Week

Abstract: FR-OR111

Effectiveness of Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Protein-Based Vaccine in Individuals with and Without CKD: A Prespecified Analysis of the DAN-RSV Trial

Session Information

• Late-Breaking Research Orals: AKI, CKD, CKM, and More
  October 23, 2026 | Location: Four Seasons Ballroom 2, Convention Center
  Abstract Time: 05:06 PM - 05:18 PM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Bartholdy, Katja Vu, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Katja Vu Bartholdy, MD

• Lassen, Mats H., Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Mats H. Lassen, MD

• Pareek, Manan, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Manan Pareek, MD, MSc, PhD

• Johansen, Niklas Dyrby, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Niklas Dyrby Johansen, MD

• Rudolph, Abby, Pfizer, New York, New York, United States

Abby Rudolph, PhD, MPH

• Rodriguez-Tenreiro Sánchez, Carmen, Genetics, Vaccines and Infectious Diseases Research Group, Galicia, Spain

Carmen Rodriguez-Tenreiro Sánchez, PhD

• Skaarup, Kristoffer G., Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Kristoffer G. Skaarup, MD

• Claggett, Brian, Harvard Medical School, Boston, Massachusetts, United States

Brian Claggett, MS, PhD

• Davidovski, Filip Soeskov, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Filip Soeskov Davidovski, MD

• Nielsen, Anne Bjerg, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Anne Bjerg Nielsen, MD

• Duus, Lisa Steen, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Lisa Steen Duus

• Espersen, Caroline, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Caroline Espersen

• Dalager-Pedersen, Michael, Aalborg Universitetshospital, Aalborg, North Denmark Region, Denmark

Michael Dalager-Pedersen, MD, PhD

• Lindholm, Matias Greve, Sjaellands Universitetshospital Roskilde, Roskilde, Region Zealand, Denmark

Matias Greve Lindholm, MD, PhD

• Larsen, Lykke, Odense Universitetshospital, Odense, Region Syddanmark, Denmark

Lykke Larsen

• Kober, Lars, Rigshospitalet Hjertecentret, Copenhagen, Capital Region of Denmark, Denmark

Lars Kober, MD, DrMed

• Solomon, Scott D., Harvard Medical School, Boston, Massachusetts, United States

Scott D. Solomon, MD

• Conde Pájaro, Mónica, Dirección Xeral de Saúde Pública, Galicia, Spain

Mónica Conde Pájaro

• Martel, Cyril JEan-MArie, Statens Serum Institut, Copenhagen, Capital Region of Denmark, Denmark

Cyril JEan-MArie Martel, PhD

• López Gómez, Vanessa, Pfizer, New York, New York, United States

Vanessa López Gómez, PharmD

• Giné-Vázquez, Iago, Genetics, Vaccines and Infectious Diseases Research Group, Galicia, Spain

Iago Giné-Vázquez, PhD

• Jensen, Jens Ulrik S., Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Jens Ulrik S. Jensen, MD, PhD

• Anatale-Tardiff, Laura, Pfizer, New York, New York, United States

Laura Anatale-Tardiff, MPH

• Martinón-Torres, Federico, Genetics, Vaccines and Infectious Diseases Research Group, Galicia, Spain

Federico Martinón-Torres, MD, PhD

• Biering-Sørensen, Tor, Gentofte Hospital, Hellerup, Capital Region of Denmark, Denmark

Tor Biering-Sørensen, MD, MSc, PhD, MPH

Group or Team Name

• FLUNITY-HD Study Group

Background

RSV is associated with increased cardiovascular (CV) risk, particularly among people with chronic kidney disease (CKD), who face a high risk of severe infection and adverse CV outcomes. In season 1 of DAN-RSV, a bivalent RSV prefusion F vaccine (RSVpreF) reduced severe clinical outcomes without evidence of heterogeneity by CKD status, though limited events precluded robust subgroup evaluation.

Methods

DAN-RSV (NCT06684743) is a pragmatic, open-label, individually randomised trial conducted during the 2024/25 and 2025/26 RSV seasons in Denmark and Galicia, Spain, with outcomes obtained through registry linkage. CKD was defined by ICD-10 codes and/or persistent kidney injury. Follow-up began 14 days after vaccination and continued through each season. The primary outcome was RSV-related respiratory tract disease (RTD) hospitalisation. Secondary and exploratory outcomes included lower RTD, cardiorespiratory and all-cause hospitalisation, mortality, acute kidney injury, end-stage and incident kidney disease, and heart failure hospitalisation.

Results

In season 1, 131,379 participants were randomised, including 13,372 (10.2%) with CKD. Effectiveness was broadly consistent by CKD status, with larger relative reductions in RTD, lower RTD, and cardiorespiratory hospitalisation and lower numbers needed to vaccinate among participants with CKD. In season 2, 331,602 additional participants in Denmark and 50,415 in Galicia were randomised, bringing the total to 513,396, including an expected CKD cohort >40,000.

Conclusion

DAN-RSV is the first large-scale randomised trial evaluating RSV vaccine effectiveness across the CKD spectrum. Its pragmatic, international design and inclusion of >40,000 participants with CKD provide a unique opportunity to assess respiratory, CV, and kidney outcomes and inform vaccination strategies in this high-risk population. The results of the CKD-stratified analyses in the complete two-season DAN-RSV trial are expected to be completed on the 30th of September, 2026.

Funding

• Commercial Support – Pfizer