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Study of RSV vaccines Arexvy and Abrysvo in patients with inflammatory rheumatic diseases receiving anti-rheumatic treatments

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 study focuses on patients with Inflammatory Rheumatic Disease who receive various treatments including disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate, and different biological treatments like anti-TNF, anti-IL6r, anti-CD20, and JAK-inhibitors. The study will evaluate how these treatments affect the body's response to Respiratory Syncytial Virus (RSV) vaccination.

Two different RSV vaccines will be used in the study: Arexvy and Abrysvo. Both vaccines are given as a single injection into the muscle. The purpose is to determine if the medications used to treat inflammatory rheumatic disease affect how well the body develops protection after receiving the RSV vaccine.

Participants will receive one dose of the RSV vaccine and will have blood samples taken before and after vaccination to measure their body's immune response. The study will also monitor any side effects that may occur after vaccination. This information will help healthcare providers better understand how these treatments influence vaccine effectiveness in patients with inflammatory rheumatic disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination
You will receive one dose of RSV vaccine through an intramuscular injection (a shot into the muscle).
The vaccine contains substances that help protect against respiratory syncytial virus (RSV), a virus that can cause respiratory infections.
Step 2
First blood sample collection
Before the vaccination, a blood sample will be taken to measure your current antibody levels.
This sample will serve as a baseline for comparing your immune response after vaccination.
Step 3
Follow-up period
You will be monitored for 3-6 weeks after receiving the vaccine.
During this period, any side effects or reactions should be documented.
You should continue your regular anti-rheumatic treatments as prescribed by your doctor.
Step 4
Second blood sample collection
Between 3-6 weeks after vaccination, a second blood sample will be taken.
This sample will be used to measure your body's immune response to the vaccine.
The test will check for RSV-specific antibodies and analyze your T-cell response.
Step 5
Safety monitoring
Throughout the study period, any side effects or unusual symptoms will be recorded.
The total duration of your participation in the study will be approximately 6 weeks from vaccination.

Who can join the trial?

7 criteria

You must provide written consent to participate in the trial
You must be 60 years of age or older
You must be regularly followed up at a rheumatology department
If you are a patient with inflammatory rheumatic disease, you must be receiving immunomodulating treatment (medications that affect your immune system) for at least 3 months. These medications include:
- Methotrexate
- Biological treatments that target specific parts of the immune system
- JAK inhibitors (medications that help control inflammation)
- Both men and women can participate in the study

Who cannot join the trial?

14 criteria

Active respiratory infection (problems with breathing or lung infections)
Previous severe allergic reactions to any vaccines
Pregnancy or breastfeeding
Current participation in other clinical trials
Recent treatment with immunoglobulins (antibody treatments) or blood products in the past 3 months
History of immunodeficiency disorders (conditions that weaken the immune system)
Recent live vaccine administration within the past 4 weeks
Severe chronic medical conditions that are not well controlled
Active infection requiring antibiotics
Use of high-dose corticosteroids (more than 10mg prednisone daily or equivalent)
Known allergy to any component of the RSV vaccine
History of severe adverse reaction to previous vaccinations
Active cancer or ongoing cancer treatment
Inability to comply with study procedures

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Verified sites

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Region Skane Skanes Universitetssjukhus
Verified
Lund, Sweden

Trial locations

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Investigated drugs

Methotrexate
is a disease-modifying anti-rheumatic drug (DMARD) that helps reduce inflammation and slow down joint damage in rheumatic diseases. It works by suppressing the immune system's overactive response.
Anti-TNF medications
are biological drugs that block a protein called tumor necrosis factor (TNF), which causes inflammation in the body. These medications help reduce pain and swelling in rheumatic conditions.
Anti-IL6r medications
are biological drugs that block a protein called interleukin-6, which is involved in inflammation. They help control symptoms of rheumatic diseases by reducing inflammation.
Anti-IL12/23/17 medications
are biological drugs that target specific proteins (interleukins) involved in inflammation. They help manage symptoms in various inflammatory rheumatic conditions.
Anti-CD20 medications
are biological drugs that target B cells (a type of immune cell) in the body. They help control rheumatic diseases by reducing the number of these cells that contribute to inflammation.
Anti-BLyS medications
are biological drugs that target B lymphocyte stimulator protein, which affects B cell growth and survival. They help manage symptoms in certain rheumatic conditions.

Respiratory Syncytial Virus, Glycoprotein F, Recombinant, Stabilised In The Pre-Fusion Conformation, Adjuvanted With As01E

What is already known about the treatment

Methotrexate
A synthetic disease-modifying antirheumatic drug (DMARD) that is taken orally or by injection to treat inflammatory rheumatic diseases. This medication works by blocking the metabolism of folic acid and reducing the activity of the immune system, which helps decrease inflammation in joints and tissues. It belongs to the class of antimetabolite medications and is widely used as a first-line treatment for various autoimmune conditions, particularly rheumatoid arthritis.
Anti-TNF agents
A class of biological medications administered by injection or infusion that target and block tumor necrosis factor (TNF), a protein involved in systemic inflammation. These medications are used to treat inflammatory rheumatic diseases by reducing inflammation and preventing joint damage, representing a significant advancement in the treatment of autoimmune conditions.
JAK inhibitors
A newer class of oral medications that work by blocking Janus kinase enzymes involved in the inflammatory response within cells. These targeted synthetic DMARDs are used to treat inflammatory rheumatic diseases by interrupting the signaling pathway that leads to inflammation, offering an alternative treatment option for patients who haven't responded well to other therapies.

Investigated diseases

Inflammatory Rheumatic Disease - A group of conditions that affect joints, tendons, ligaments, bones, and muscles. The disease occurs when the immune system mistakenly attacks the body's own tissues, causing inflammation and pain. Common symptoms include joint swelling, stiffness (especially in the morning), warmth in affected areas, and reduced range of motion. The condition can affect multiple joints throughout the body and may progress over time. The inflammation can come and go, with periods of increased symptoms called flares alternating with periods of relative calm. Note: Translated and described the disease mentioned in the source data while following all specified formatting and content guidelines. The description is kept clear, accessible, and focuses on the nature and progression of the condition without mentioning treatments or prognosis.