Vaccination against RSV in patients with weakened immune systems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of administering two doses of the RSV vaccine Arexvy to immunocompromised patients, compared to the standard one dose given to healthy elderly individuals. The research focuses on patients with conditions such as solid tumors and hematological malignancies, particularly those who have undergone hematopoietic stem cell transplantation. By assessing immune responses after both doses, the study aims to determine if additional vaccination can enhance protection against RSV infections in these high-risk groups.

Why it matters

Who can join: the full rules

General inclusion criteria

1. Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.
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. Additional inclusion criteria for "group 1":

   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. Additional inclusion criteria for "group 2":

   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. Additional inclusion criteria for "group 3":

   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. Additional inclusion criteria for "group 4":

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.

Where it's running

• Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna
  Vienna, Austria Recruiting

Study contacts

• Study coordinator: Angelika Wagner, MD, PhD
• Email: angelika.wagner@meduniwien.ac.at
• Phone: +43 1 40160 38276

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Revaccination with RSV vaccine during subsequent pregnancies

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• Revaccination with SCB-1019T vaccine in older adults

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• Evaluating the effectiveness of RSV vaccines in real-world settings

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• Measuring how RSV affects young children seen in clinics and hospitals

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  Recruiting Association Clinique Thérapeutique Infantile du val de Marne · Créteil · NCT04743609

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.