Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-09-19
2026-03-31
Brief Summary
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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.
Detailed Description
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Currently, one dose of the RSV vaccine is recommended for the elderly (≥ 60 years) according to the SmPC and national recommendations. However, it is not clear yet, whether in immunocompromised patients such as those with solid tumors, hemato-oncological malignancies with and without hematopoietic stem cell transplantation (HSCT) or those with biological treatments one dose of RSV vaccine would be sufficient to induce immune responses or if these patients would benefit from a second dose.
It is planned to evaluate immune responses after one and two doses with the adjuvanted RSV vaccine Arexvy in immunocompromised study groups compared to responses of healthy, elderly individuals receiving one vaccine dose only. Our analysis plan will include humoral and cellular immune responses after the first and second dose in immunocompromised patients belonging to different study groups compared to responses after one vaccine dose in controls.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Group 1-3 (2 times verum)
Group 1-3 receive 2 doses of the RSV vaccine at visit 1 and visit 3, 1-2 months apart.
Arexvy powder and suspension for injection
Arexvy powder and suspension for injection (RSV vaccine)
Group 4 (1 time verum, 1 time placebo, randomised)
Group 4 receives 1 doses of the RSV vaccine or placebo at visit 1 and visit 3.
Arexvy powder and suspension for injection
Arexvy powder and suspension for injection (RSV vaccine)
Interventions
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Arexvy powder and suspension for injection
Arexvy powder and suspension for injection (RSV vaccine)
Eligibility Criteria
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Inclusion Criteria
2. Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
3. Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.
4. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, post-menopause, premenarche, bilateral oophorectomy, or bilateral salpingectomy
5. Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to first Arexvy vaccination and agreed to continue adequate contraception for at least 1 month after completion of the last study intervention administration, and has a negative pregnancy test on the day of first vaccination prior to vaccine application.
6. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.
7.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 7.2. Diagnosis of a hemato-oncological disease: multiple myeloma including early stage disease or lymphoma in participants medically stable in the opinion of the investigator at study inclusion.
7.3. Participants without SCT or ≥3 months after autologous SCT until 24 months after SCT. SCT \>24 months, if they have ongoing immunomodulatory/suppressive treatment.
7.4. Immunosuppressive or modulating medication related to the hemato-oncological disease are allowed.
8.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 8.2. Diagnosis of lung cancer ≥ stage 1. 8.3. Ongoing cancer treatment (including chemotherapy and immunotherapy) or initiation planned within 14 days and treatment initiation/vaccinations preferentially scheduled between treatment cycles.
9.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 9.2. Diagnosis of an autoimmune/chronic inflammatory disease with chronic inflammatory bowel disease (IBD) or rheumatoid arthritis (RA).
9.3. Treatment with biologicals such as TNF-alpha blocker, anti-CD20, JAK-inhibitors or other biological treatment (combinations with DMARDs, immunomodulators or steroidal or non-steroidal anti-inflammatory drugs are allowed).
9.4. Stable disease at time of study entry.
10.1. Age ≥60 years at the time of signing the Informed consent form (ICF). 10.2. Healthy, as established by medical history before entering the study with medically stable/controlled chronic conditions such as diabetes, hypertension or cardiac disease allowed.
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Medical University of Vienna
OTHER
Responsible Party
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Angelika Wagner
Principal Investigator
Locations
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Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Angelika Wagner, MD, PhD
Role: backup
Other Identifiers
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ISPTM-RSV-001
Identifier Type: -
Identifier Source: org_study_id