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 - 08/07/26

Doi : 10.1016/j.ahj.2026.107497

Mats C. Højbjerg Lassen, MD, MSc, PhD ^a,^b, Sine H. Christensen, MSc ^a,^b, Niklas D. Johansen, MD ^a,^b, Marat Yafasov, MD ^a,^b, Manan Pareek, MD, MSc, PhD ^a,^b, Abby E. Rudolph, PhD, MPH ^c, Carmen Rodriguez Tenreiro-Sánchez, PhD ^d,^e,^f,^g, Kristoffer G. Skaarup, MD ^a,^b, Daniel Modin, MD ^a,^b, Brian L. Claggett, PhD ^h, Carsten S. Larsen, MD, DMSc ⁱ, Lykke Larsen, MD, PhD ^j, Lothar Wiese, MD, PhD ^k, Michael Dalager-Pedersen, MD, PhD ^l,^m, Matias G. Lindholm, MD, PhD ⁿ, Lars Køber, MD, DMSc ^o,^a, Scott D. Solomon, MD ^h, Jens Ulrik Stæhr Jensen, MD, PhD ^a,^p, Cyril Jean- Marie Martel, PhD ^q, Negar Aliabadi, MD, MS ^c, Claudia Schwarz, PhD ^c, Mette Skovdal, MSc ^c, Pingping Zhang, MS ^c, Vanessa López-Gómez, BPharm ^c, Sabrina Welsh, MPH ^c, Bradford D. Gessner, MD ^c, Federico Martinón-Torres, MD, PhD ^d,^e,^f,^g, Elizabeth Begier, MD, MPH ^c, Tor Biering-Sørensen, MD, MSc, MPH, PhD ^a,^b,^o,^r,^⁎

^a Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark

^b Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

^c Pfizer, New York, NY

^d Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), Santiago de Compostela, Galicia, Spain

^e WHO Collaborating Centre for Vaccine Safety, Santiago de Compostela, Galicia, Spain

^f Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain

^g Translational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago (SERGAS) and University of Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain

^h Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

ⁱ Department of Clinical Medicine—Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark

^j Research Unit for Infectious Diseases, Odense University Hospital, Odense, Denmark

^k Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark

^l Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark

^m Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark

ⁿ Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark

^o Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

^p Respiratory Medicine Section, Department of Medicine, Copenhagen University Hospital – Herlev and Gentofte, Copenhagen, Denmark

^q Epidemiological Infectious Disease Preparedness, Statens Serum Institute, Copenhagen, Denmark

^r Steno Diabetes Center Copenhagen, Copenhagen, Denmark

^⁎ Reprint requests: Tor Biering-Sørensen, MD, MSc, MPH, PhD, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark. Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital Gentofte Hospitalsvej 8, 3.th. Hellerup 2900 Denmark

ABSTRACT

Background

Respiratory syncytial virus (RSV) is a major cause of respiratory morbidity in adults, particularly among older individuals and those with comorbidities. The DAN-RSV trial was initiated to evaluate bivalent RSV prefusion F (RSVpreF) vaccine effectiveness in preventing RSV-related hospitalizations.

Methods

DAN-RSV is a large-scale, pragmatic, randomized clinical trial that enrolled participants during the 2024/2025 (Danish adults aged ≥60 years) and 2025/2026 (adults aged ≥18 years in Denmark and Galicia, Spain) Northern hemisphere winter seasons. In Denmark, nationwide registries and the national electronic messaging system were used to identify and recruit eligible citizens; individuals could provide electronic informed consent remotely or in-person. In Galicia, participants were recruited via text message invitations and consented on-site.

Results

During the initial 2024/2025 season, 131,379 Danish adults aged ≥60 years were enrolled. Following lower-than-expected event accrual and expansion of the EU indication to adults 18 years and older, the trial was extended to continue enrollment of adults aged ≥18 years across Denmark and Galicia, Spain during the 2025/2026 RSV season. Key protocol updates include expansion of the eligibility criteria to adults aged ≥18 years, inclusion of an additional study site within the integrated public healthcare infrastructure of Galicia, Spain, and an increase in the planned sample size to up to approximately 690,000 participants across both seasons. The randomization strategy (1:1 to RSVpreF vaccine or no vaccine), primary endpoint (RSV-related respiratory tract disease hospitalization), and statistical framework, including intention-to-treat analyses and hierarchical testing, remain unchanged.

Conclusion

The extension of the DAN-RSV trial is expected to improve statistical precision, enhance generalizability, and strengthen the robustness of the effect estimates. The updated design will provide reliable randomized evidence on bivalent RSVpreF vaccine effectiveness to inform clinical and public health decision-making.

Il testo completo di questo articolo è disponibile in PDF.

Mappa

Key changes to the trial protocol

Extension of trial enrollment, broadening eligibility criteria, and sample size adjustment

Inclusion criteria changes

Recruitment for the extended DAN-RSV season

Inclusion of an international site

Rationale for trial extension

Statistical considerations

Sample size adjustment

General statistical approach

Datasets and analysis of multiple seasons

Additional subgroup analyses

Conclusion

Data availability

Funding

CRediT authorship contribution statement

Esportazione

Vol 300

Articolo 107497- ottobre 2026 Ritorno al numero

Articolo precedente

Progression of bicuspid-related aortopathy in patients undergoing transcatheter aortic valve implantation: Rationale and design of the international, multicenter PROSPERO-TAVI registry
Giuliano Costa, Giulia Laterra, Sofia Sammartino, Ole De Backer, Yuheng Jia, Thomas Pilgrim, Tomii Daijiro, Matteo Montorfano, Francesco Ancona, Barbara Bellini, Simon Redwood, Tiffany Patterson, Ran Kornowski, Ashraf Hamdan, Darren Mylotte, Paolo Alberto Del Sole, Francesco Saia, Tullio Palmierini, Francesco Bedogni, Caterina Gandolfo, Stefano Cannata, Philippe Garot, Emmanuel Gall, Marco De Carlo, Marco Angelillis, Sebastiano Immè, Corrado Tamburino, Antonio Mangieri, Francesco Tartaglia, Luis Nombela, Ignacio Amat Santos, Mario Garcia Gomez, Guilherme Attizzani, Marco Frazzetto, Mariachiara Calì, Kevin Millar, John Webb, Marco Barbanti

| Articolo seguente

Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials
Mary M. McDermott, Madeline D. Cetlin, Kathryn J. Domanchuk, Shujun Xu, Mary O. Whipple, Tamar Polonsky, Michael H. Criqui, Jack M. Guralnik, Lu Tian, Lihui Zhao, Karen J. Ho, Philip Greenland, Diane Treat-Jacobson

Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.

Già abbonato a @@106933@@ rivista ?

connettersi o creare un account

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 - 08/07/26

ABSTRACT

Background

Methods

Results

Conclusion

Mappa

Citazioni Export

File

Contenuto

Il mio account

Aide & support

Dichiarazione CNIL