Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Adults

Conditions

RSV

Keywords

RSV, Vaccination, Pragmatic, Registry, Lower respiratory tract disease, Respiratory tract disease, Respiratory, Cardiovascular

Brief summary

The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.

Detailed description

The study is a pragmatic, registry-based, open-label, individually randomized trial. Administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 690,000 participants. Participants will be individually randomized 1:1 to receive either a bivalent RSV prefusion F vaccine (RSV vaccine) or no RSV vaccine. The trial is designed to assess the vaccine effectiveness of the RSV vaccine vs. no RSV vaccine on RSV-related and all-cause cardio-respiratory outcomes.

Skaarup KG, Lassen MCH, Yafasov M, Pareek M, Christensen SH, Johansen ND, Rudolph AE, Rodriguez-Tenreiro-Sánchez C, Modin D, Claggett BL, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Lindholm MG, Jensen AMR, Dons M, Bernholm KF, Davidovski FS, Duus LS, Ottosen CI, Nielsen AB, Borchsenius JH, Espersen C, Köse G, Fussing FH, Lenz IT, Christensen J, Simonsen JØ, Afzal M, Bartholdy KV, Langhoff ACF, Køber L, Solomon SD, Jensen JUS, Martel CJ, Giné-Vázquez I, Duran-Parrondo C, Piñeiro-Sotelo M, Cribeiro-González M, Conde-Pájaro M, Mirás-Carballal S, González-Pérez JM, Gessner BD, Aliabadi N, Schwarz C, Skovdal M, Moulton LH, Zhang P, López-Gómez V, Welsh S, Anatale-Tardiff L, Cane A, Hayford K, Martinón-Torres F, Begier E, Biering-Sørensen T.

2026-09-07

10.1093/ejhf/xuag282

Durability of RSV Prefusion F Vaccine Protection across Two RSV Seasons

Mats C Højbjerg Lassen, Niklas Dyrby Johansen, Sine H. Christensen, Abby E. Rudolph, Kristoffer G. Skaarup et al. (37 authors)

NEJM Evidence2026-08-291 citations

10.1056/evidoa2600242

Bivalent RSV Prefusion F Vaccine to Prevent Hospitalizations in Adults

Mats C. Lassen, Sine H. Christensen, Marat Yafasov, Manan Pareek, Niklas Dyrby Johansen et al. (57 authors)

NEJM Evidence2026-08-291 citations

10.1056/evidoa2600272

Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial.

Lassen MCH, Johansen ND, Christensen SH, Aliabadi N, Skaarup KG, Modin D, Claggett BL, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Lindholm MG, Jensen AMR, Dons M, Bernholm KF, Davidovski FS, Duus LS, Ottosen CI, Nielsen AB, Borchsenius JH, Espersen C, Köse G, Fussing FH, Pareek M, Køber L, Solomon SD, Jensen JUS, Martel CJ, Gessner BD, Schwarz C, Gonzalez E, Skovdal M, Moulton LH, Zhang P, Begier E, Biering-Sørensen T.

2025-10-017 citations

10.1001/jama.2025.15405

RSV Prefusion F Vaccine for Prevention of Hospitalization in Older Adults

Mats Christian Højbjerg Lassen, Niklas Dyrby Johansen, Sarah Louise Christensen, Negar Aliabadi, Kristoffer Grundtvig Skaarup et al. (35 authors)

New England Journal of Medicine2025-08-309 citations

10.1056/nejmoa2509810

A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein-based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design.

Lassen MCH, Christensen SH, Johansen ND, Aliabadi N, Skaarup KG, Modin D, Claggett BL, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Lindholm MG, Køber L, Solomon SD, Stæhr Jensen JU, Martel CJ, Schwarz C, Gonzalez E, Skovdal M, Moulton LH, Zhang P, Gessner BD, Begier E, Biering-Sørensen T.

2025-07-282 citations

10.1016/j.ahj.2025.07.068

Interventions

BIOLOGICALRSV prefusion F protein-based vaccine

For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age 18 years and above * Informed consent form has been signed and dated

Exclusion criteria

* There are no specific

Design outcomes

Primary

Measure	Time frame
Hospitalization for RSV-related respiratory tract disease	≥14 days after initially booked vaccination/ information visit date up to 8 months

Secondary

Measure	Time frame	Description
RSV-related respiratory tract disease hospitalization (as-treated)	≥14 days after initially booked vaccination/ information visit date up to 8 months	Among the as-treated study population with balanced follow up time between study arms
RSV-related respiratory tract disease hospitalization	≥14 days after actual vaccination date/ booked information visit date up to 8 months	Primary outcome evaluated among the as-treated study population with balanced follow up time between study arms
Hospitalization for RSV-related lower respiratory tract disease	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
Hospitalization for RSV-related respiratory tract disease by age groups	≥14 days after initially booked vaccination/ information visit date up to 8 months	Stratified by age groups (18-59, 60-74 years and 75+ years)
Hospitalization for RSV-related respiratory tract disease in subsequent seasons	From June 1, 2025 up to 12 months (2025/2026 season) and June 1, 2026 up to 12 months (2026/2027 season)	Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)
RSV-related hospitalization	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
All-cause respiratory tract disease hospitalization	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
RSV-related cardio-respiratory hospitalization	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
All-cause cardio-respiratory hospitalization	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
All-cause lower respiratory tract disease hospitalization	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
All-cause hospitalization	≥14 days after initially booked vaccination/ information visit date up to 8 months	—
All-cause mortality	≥14 days after initially booked vaccination/ information visit date up to 8 months	—

Countries

Denmark, Spain

Contacts

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

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Outcome results

None listed