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Study on Immune Response to Recombinant Zoster Vaccine in Rheumatic Disease Patients Using Baricitinib, Tofacitinib, or Methotrexate

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with rheumatic diseases, which are conditions that cause pain and inflammation in the joints and muscles. The study will explore the effects of a vaccine called the recombinant zoster vaccine (RZV), which is designed to protect against shingles, a painful rash caused by the same virus that causes chickenpox. The trial will involve patients who are taking medications known as JAK inhibitors (such as baricitinib, tofacitinib, filgotinib, and upadacitinib) either alone or in combination with methotrexate, as well as those taking methotrexate by itself. These medications are used to manage rheumatic diseases by reducing inflammation and suppressing the immune system.

The purpose of the study is to assess how well the immune system responds to the RZV vaccine in these patients. The study will monitor the levels of specific antibodies and immune cells that are expected to increase after vaccination. Participants will receive two doses of the vaccine, and their immune response will be measured one month after the second dose. The study will also track any symptoms that occur after vaccination and examine changes in immune system markers over time.

Throughout the study, researchers will collect information on how the immune system reacts to the vaccine and how long the response lasts. They will also compare the immune response to the RZV vaccine with responses to COVID-19 vaccines in similar patients. The study is expected to provide valuable insights into the effectiveness of the RZV vaccine in people with rheumatic diseases who are taking immunosuppressive medications.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, the first step involves an initial visit. During this visit, eligibility is confirmed, and informed consent is obtained. The patient's medical history is reviewed to ensure they meet the criteria for participation.

    The patient will be informed about the study's purpose, procedures, and any potential risks or benefits. This is an opportunity to ask questions and understand the commitment involved.

  2. Step 2

    First vaccination

    The patient receives the first dose of the recombinant zoster vaccine (RZV). This vaccine is administered as an injection.

    The patient is monitored for any immediate reactions following the vaccination. Instructions are provided on what to expect and how to report any symptoms experienced in the following days.

  3. Step 3

    Follow-up after first vaccination

    Seven days after the first vaccination, the patient is asked to report any symptoms experienced. This helps in understanding the vaccine's immediate effects.

    The patient may be required to visit the clinic for a brief check-up to ensure there are no adverse reactions.

  4. Step 4

    Second vaccination

    Approximately 60 days after the first dose, the patient receives the second dose of the RZV vaccine.

    Similar to the first dose, the patient is monitored for any immediate reactions and provided with instructions for reporting symptoms.

  5. Step 5

    Follow-up after second vaccination

    Seven days after the second vaccination, the patient reports any symptoms experienced. This information is crucial for assessing the vaccine's effects.

    A clinic visit may be scheduled to ensure the patient's well-being and to address any concerns.

  6. Step 6

    90-day assessment

    Ninety days after the first vaccination, the patient undergoes an assessment to measure the immune response. This includes blood tests to evaluate antibody levels and T cell responses.

    The results help in understanding how the immune system has responded to the vaccine.

  7. Step 7

    Long-term follow-up

    The patient continues to be monitored for up to a year to assess the persistence of the immune response. This involves periodic blood tests and health assessments.

    The study aims to gather data on the long-term effects of the vaccine and its impact on rheumatic disease management.

Who can join the trial?

5 criteria

  • Patients with rheumatic diseases who are currently being treated with JAK-inhibitors (either alone or combined with Methotrexate) or with Methotrexate only. JAK-inhibitors are medications that help reduce inflammation by blocking certain enzymes in the body.
  • Patients must be scheduled to receive the RZV vaccine. This is a vaccine used to protect against shingles.
  • Patients must be in a stable clinical condition, which means their health status is not changing rapidly, as determined by the doctors conducting the study.
  • Patients must be 18 years of age or older.
  • Patients must be able and willing to provide informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

10 criteria

  • Patients with any other **serious health conditions** that might interfere with the study.
  • Patients who have received any other **vaccines** within 4 weeks before the study starts.
  • Patients who are currently participating in another **clinical trial**.
  • Patients who have a known **allergy** to any component of the study vaccine.
  • Patients who have a history of **severe allergic reactions** to vaccines.
  • Patients who are **pregnant** or **breastfeeding**.
  • Patients who have received **blood products** or **immunoglobulins** within 3 months before the study.
  • Patients with a **weakened immune system** due to conditions like HIV/AIDS or medications that suppress the immune system.
  • Patients with a history of **cancer** within the last 5 years, except for certain skin cancers.
  • Patients with **uncontrolled chronic diseases** that could affect the study results.
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Investigated drugs

  • Recombinant Zoster Vaccine (RZV)

    is a vaccine designed to protect against shingles, a painful rash caused by the reactivation of the chickenpox virus. In this trial, the vaccine is being studied to see how well it works in people with rheumatic diseases who have weakened immune systems. The focus is on how the body’s immune system responds to the vaccine, specifically looking at certain antibodies and T cells, which are important parts of the immune system.

  • JAK Inhibitors (JAKi)

    are a type of medication used to treat rheumatic diseases by reducing inflammation and the activity of the immune system. In this trial, researchers are studying how these medications affect the immune response to the shingles vaccine. The goal is to understand if taking JAK inhibitors changes how well the vaccine works in people with rheumatic diseases.

  • Methotrexate

    is a medication commonly used to treat rheumatic diseases by slowing down the immune system and reducing inflammation. In this trial, Methotrexate is being studied to see how it affects the immune response to the shingles vaccine. Researchers want to know if Methotrexate changes how the body responds to the vaccine in people with rheumatic diseases.

What is already known about the treatment

Recombinant Zoster Vaccine (RZV) – This vaccine is administered via injection to help protect against shingles, particularly in individuals with weakened immune systems due to rheumatic diseases. It is currently being studied in clinical trials to understand its effectiveness in patients who are on immunosuppressive treatments like JAK inhibitors or Methotrexate. The vaccine works by stimulating the body's immune system to produce antibodies and T cells that target the virus responsible for shingles. It is classified as a vaccine and is primarily indicated for preventing shingles in at-risk populations.

Investigated diseases

  • Rheumatoid Arthritis

    Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation of the synovial membrane, leading to swelling and pain. Over time, the inflammation can cause damage to cartilage and bone within the joint. This damage can result in joint deformity and loss of function. The disease often progresses in a symmetrical pattern, affecting the same joints on both sides of the body. It can also cause systemic symptoms such as fatigue and fever.

  • Psoriatic Arthritis

    Psoriatic arthritis is an inflammatory arthritis associated with psoriasis, a skin condition. It can affect any joint in the body and may cause swelling, pain, and stiffness. The disease can lead to joint damage and deformities if not managed. It often affects the fingers and toes, causing them to swell like sausages, a condition known as dactylitis. Psoriatic arthritis can also cause changes in the nails, such as pitting or separation from the nail bed. The progression of the disease can vary, with periods of remission and flare-ups.

  • Ankylosing Spondylitis

    Ankylosing spondylitis is a type of arthritis that primarily affects the spine, although other joints can be involved. It causes inflammation of the vertebrae, which can lead to severe, chronic pain and discomfort. Over time, the inflammation can lead to the fusion of the vertebrae, resulting in a loss of flexibility and a hunched posture. The disease often begins in the lower back and can progress upwards. It may also affect other areas such as the hips, shoulders, and rib cage. Symptoms can vary in intensity and may come and go.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518190-34-00Protocol codeRC31/24/0156Estimated enrolment60 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

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