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RECRUITING
NCT06597916
PHASE2

RSV Vaccination in Immunocompromised Patients.

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

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

BIOLOGICAL

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