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RSV Vaccination in Immunocompromised Patients.
Sponsor: Medical University of Vienna
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.
Official title: A Phase-2b Controlled Study to Evaluate the Humoral and Cellular Immune Response and Safety Following One and Two Doses of an Adjuvanted RSV Subunit Vaccine in Immunocompromised Patients Aged 18 Years and Older.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-09-19
Completion Date
2026-03-31
Last Updated
2024-11-27
Healthy Volunteers
Yes
Conditions
Interventions
Arexvy powder and suspension for injection
Arexvy powder and suspension for injection (RSV vaccine)
Locations (1)
Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna
Vienna, Austria