Actively Recruiting
RSV Vaccination in Immunocompromised Patients.
Led by Medical University of Vienna · Updated on 2024-11-27
200
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RSV Vaccination in Immunocompromised Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who can understand and comply with study requirements
- Living in the community or assisted-living with minimal assistance
- Able to give written informed consent
- Female participants of non-childbearing potential or using adequate contraception with negative pregnancy test
- Medically stable participants with chronic medical conditions
- Group 1: Age 18+ with hemato-oncological disease, stable, with specific stem cell transplantation criteria
- Group 2: Age 18+ with lung cancer stage 1 or higher, undergoing or planning cancer treatment
- Group 3: Age 18+ with autoimmune or chronic inflammatory disease, stable, on biological treatments
- Group 4: Age 60+ healthy or medically stable with controlled chronic conditions such as diabetes or hypertension
You will not qualify if you...
- None explicitly listed in the provided eligibility criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
A
Angelika Wagner, MD, PhD
CONTACT
I
Ines Zwazl, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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