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Characterization of the immune response in immunosuppressed patients with rheumatic diseases, including to the recombinant zoster vaccine
EU CTIS ID: 2024-518190-34-00
What this study is testing
to assess the immunogenicity of the RZV vaccine (gE-specific antibody and T cell responses) in RD patients treated with JAKi (monotherapy or combined with Methotrexate) or with Methotrexate only one month after the second vaccine dose (day 90 after dose 1)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with rheumatic diseases currently with JAK-inhibitors (monotherapy or combined with Methotrexate) or with Methotrexate only and scheduled to receive the RZV vaccine
- In stable clinical condition, as determined by the recruiting investigators
- ≥ 18 years of age
- Able and willing to provide informed consent
You likely can't join if
- Ongoing signs of febrile or non-febrile infection
- Patient under legal protection (only for France)
- Recent pregnancy with delivery in the six months preceding vaccination and/or planned pregnancy in the six months following RZV vaccination
- Immunosuppression from the following: HIV infection; Current malignant neoplasm; primary immunodeficiency; recent (<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; conditions requiring medication with immunosuppressive drugs (including steroids > 5 mg/day))
- Having received a vaccine in the last month or is expected to receive a vaccine in the next month
- Presented with herpes zoster in the previous year
See the full eligibility criteria
- Patients with rheumatic diseases currently with JAK-inhibitors (monotherapy or combined with Methotrexate) or with Methotrexate only and scheduled to receive the RZV vaccine
- In stable clinical condition, as determined by the recruiting investigators
- ≥ 18 years of age
- Able and willing to provide informed consent
- Ongoing signs of febrile or non-febrile infection
- Patient under legal protection (only for France)
- Recent pregnancy with delivery in the six months preceding vaccination and/or planned pregnancy in the six months following RZV vaccination
- Immunosuppression from the following: HIV infection; Current malignant neoplasm; primary immunodeficiency; recent (<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; conditions requiring medication with immunosuppressive drugs (including steroids > 5 mg/day))
- Having received a vaccine in the last month or is expected to receive a vaccine in the next month
- Presented with herpes zoster in the previous year
- Hypersensitivity to the active substance or to one of the excipients
- Pregnancy or breastfeeding (only for France)
- Woman of childbearing age and without effective contraception throughout the duration of the study (only for France)
- Non-affiliation to the French Social Security System. (only for France)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.