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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.10.2025

Trial locations

Investigated drugs:

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

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.

JAK inhibitors are targeted medications that work by blocking Janus kinase enzymes involved in inflammation. They help control symptoms of rheumatic diseases by reducing inflammatory signals in the body.

RSV vaccine is a vaccine designed to protect against respiratory syncytial virus, a common respiratory virus that can cause severe infections.

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.

Trial ID:

2024-518191-31-00

Protocol code:

RSV-REUMA

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?