RecruitingPhase 2NCT06597916

RSV Vaccination in Immunocompromised Patients.

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.

Sponsor

Medical University of Vienna

Enrollment

200 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

RSV Infection

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the RSV vaccine (Arexvy) in people who are immunocompromised — meaning their immune system is weakened — to see how well the vaccine works and is tolerated in these higher-risk groups, including blood cancer patients, lung cancer patients, autoimmune disease patients, and healthy older adults. **You may be eligible if...** - You are 18 or older (or 60+ for the healthy adults group) - You fall into one of these categories: multiple myeloma or lymphoma; lung cancer currently being treated; autoimmune disease (IBD or rheumatoid arthritis) on biologic medications; or a healthy older adult (60+) with controlled chronic conditions - You are willing to follow the vaccine schedule and study procedures **You may NOT be eligible if...** - You are of childbearing potential without adequate contraception - You are in an unstable medical condition according to your doctor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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