A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update.
Am Heart JJun 1, 2026 (epub)
Mats C Højbjerg Lassen, Sine H Christensen, Niklas D Johansen et al.
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In 30 seconds
The DAN-RSV trial is a pragmatic randomized controlled trial assessing the effectiveness of the bivalent RSV prefusion F vaccine in preventing RSV-related hospitalizations among adults. Initially focused on Danish adults aged ≥60 years, the trial has expanded to include adults aged ≥18 years in Denmark and Galicia, Spain, with a planned sample size of approximately 690,000 participants.
Key findings
- 131,379 Danish adults aged ≥60 years were enrolled during the 2024/2025 season.
- The trial's sample size is planned to increase to approximately 690,000 participants across both seasons.
- The primary endpoint remains RSV-related respiratory tract disease hospitalization.
Why it matters
Understanding the effectiveness of the RSV vaccine in preventing hospitalizations is crucial for managing respiratory morbidity in older adults and those with comorbidities, particularly as RSV poses significant health risks in these populations.