Actively Recruiting
A Phase-2b Study to Evaluate Immune Response and Safety of One and Two Doses of an Adjuvanted RSV Vaccine in Immunocompromised Patients Aged 18 Years and Older
Led by Medical University of Vienna · Updated on 2024-11-27
200
Participants Needed
1
Research Sites
30 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, often peaking in autumn and winter in temperate zones. Immunocompromised patients, such as those with underlying respiratory, cardiovascular, endocrinological diseases or after hematologic stem cell transplantation (HSCT), face increased risk of severe RSV infections requiring intensive care, with high mortality rates. This study aims to evaluate if immunocompromised patients benefit from receiving two doses of the adjuvanted RSV vaccine Arexvy compared to one dose, to better inform vaccine recommendations. Participants in this randomized, phase 2b study are divided into groups based on their health conditions. Groups 1 to 3, consisting of immunocompromised patients with hemato-oncological diseases, lung cancer, or autoimmune/chronic inflammatory diseases, will receive two doses of Arexvy about 1 to 2 months apart. Group 4, made up of healthy elderly individuals aged 60 and older, will receive either one dose of Arexvy and one placebo dose. The additional dose for immunocompromised groups is administered off-label. Throughout the study, researchers will measure the immune responses by assessing neutralizing antibodies against RSV-A and RSV-B after each vaccine dose, along with monitoring safety. Participants will be followed for up to 14 months to evaluate the immune response increase after the second dose compared to the first. The study includes evaluation of both humoral and cellular immunity and will help guide future vaccination strategies for immunocompromised patients.
CONDITIONS
Brief Title
RSV Vaccination in Immunocompromised Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with protocol requirements
- Living in community or assisted-living with minimal help and responsible for self-care
- Able to provide written informed consent
- Female participants of non-childbearing potential or using adequate contraception if of childbearing potential
- Medically stable with or without chronic medical conditions
- Group 1: Age 18 or older; diagnosis of multiple myeloma or lymphoma; no stem cell transplant or 3+ months post-autologous SCT; allowed immunosuppressive treatments
- Group 2: Age 18 or older; diagnosis of lung cancer stage 1 or higher; ongoing or planned cancer treatment
- Group 3: Age 18 or older; diagnosis of autoimmune or chronic inflammatory disease (IBD or RA); treated with biologicals; stable disease
- Group 4: Age 60 or older; healthy or medically stable with controlled chronic conditions such as diabetes, hypertension, or cardiac disease
You will not qualify if you...
- Participants unable to comply with protocol or provide informed consent
- Female participants of childbearing potential not using adequate contraception or with positive pregnancy test
- Participants with unstable or uncontrolled medical conditions
- Participants with diseases or treatments not listed in inclusion criteria
- Participants younger than 18 years (groups 1-3) or younger than 60 years (group 4)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 months
Participants receive one or two doses of the RSV vaccine or placebo depending on their group assignment.
2 visits (in-person) approximately 1 to 2 months apart
Duration - Up to 14 months
Participants are monitored for immune response and safety for up to 14 months after vaccination.
Periodic visits for immune response and safety assessments
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
I
Ines Zwazl, MSc
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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