drugset / Trial / NCT06597916

RSV Vaccination in Immunocompromised Patients.

NCT06597916

RandomizedParallel-groupSingle-blindOther

Summary

Respiratory syncytial Virus (RSV) causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumn/winter in temperate climate zones. Apart from infants and elderly individuals, patients with underlying substantial respiratory, cardiovascular, endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection (LRTI) requiring intensive care associated with increased mortality. For certain risk groups such as patients after hematologic stem cell transplantation (HSCT) in-hospital mortality may be as high as 70 %. A causally related, RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific. The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose. The additional dose will be administered off label.

Timeline

Start
2024-09-19
Primary completion
2025-08-31
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Arexvy Vaccine