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AuthorisedTherapeutic use (Phase IV)Interventional

Vaccination against respiratory syncytial virus in patients with inflammatory rheumatic diseases. The impact of anti-rheumatic treatments on the RSV immune response.

This study is investigating how effective the new RSV (Respiratory Syncytial Virus) vaccines are for people living with inflammatory rheumatic diseases. These conditions include things like rheumatoid arthritis or lupus. We want to understand if the treatments people are taking for their rheumatic disease change how their body responds to the RSV vaccine. Specifically, we'll be looking at how well the vaccine helps their immune system produce protective antibodies. This information is important because it can help doctors and patients make better decisions about RSV vaccination, ensuring people with these conditions get the best possible protection against the virus. The study is in its final phase, meaning the vaccines are already approved for use.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Region Skane
Enrolment target
180
Start
09 Jul 2025

What is this study about?

You might have heard about RSV, which is a common virus that usually causes mild cold-like symptoms. However, for some adults, especially those with certain health conditions or weaker immune systems, RSV can lead to more serious problems like pneumonia or bronchitis. People with inflammatory rheumatic diseases, which are conditions that cause your immune system to mistakenly attack your own body (like rheumatoid arthritis or lupus), might be at higher risk.

Vaccines are a way to train your body's immune system to fight off viruses before you get sick. Recently, new vaccines have become available to help protect adults from RSV. This study wants to understand how well these RSV vaccines work in people who have inflammatory rheumatic diseases. It's especially important to know this because the medications used to treat rheumatic diseases can sometimes affect how strong your immune system is, and therefore, how well it responds to a vaccine.

The main goal of the study is to see if your body makes enough protective substances called antibodies after getting the RSV vaccine. We will measure these antibodies before and a few weeks after vaccination. We will also look at other parts of your immune response and track any side effects people experience. Finding out how well these vaccines work for people with inflammatory rheumatic diseases will help doctors give the best advice and care, making sure everyone can get good protection from RSV.

Key takeaways

  • Study examines RSV vaccine effectiveness in people with inflammatory rheumatic diseases.
  • Aims to understand how current treatments might affect vaccine response.
  • Involves receiving an approved RSV vaccine and having blood tests before and after.
  • Helps inform better vaccination choices for people with these conditions.
  • Participation involves a short commitment (a few weeks).

Who may be eligible?

This study is looking for adults aged 18 and over. It's open to everyone, regardless of whether you are male or female.

To join, you must have an inflammatory rheumatic disease. This means conditions where your immune system mistakenly attacks parts of your body, such as rheumatoid arthritis, lupus, or similar conditions.

More specific details about your health and current medications would be discussed with the study team to confirm if the study is right for you.

Quick self-check
  • Are you 18 years old or older?
  • Do you have an inflammatory rheumatic disease (like rheumatoid arthritis or lupus)?
  • Are you able to attend appointments for blood tests?
  • Are you comfortable receiving an RSV vaccination?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive one of the approved RSV vaccines. Before the vaccination, we would take a blood sample. Then, 3 to 6 weeks after you've had the vaccine, you would come back for another blood sample. This second sample will help us see if your body has made protective antibodies in response to the vaccine. We would also ask you to report any side effects you might experience after the vaccination. The total time you would be involved in the study would be just a few weeks, typically less than two months, covering the vaccination and the follow-up blood test.

Potential risks and benefits

By taking part, you could help us understand how effectively RSV vaccines protect people with inflammatory rheumatic diseases, which could benefit many patients in the future. You will also receive an RSV vaccine, which is designed to protect you from the virus. Potential risks are generally mild and similar to any vaccine, such as arm soreness, tiredness, or a mild fever. More serious reactions are rare but possible. You are absolutely free to change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Sweden

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but it can be more serious for some adults, especially those with certain health conditions.

What is an 'inflammatory rheumatic disease'?

These are conditions where your body's immune system mistakenly attacks your own tissues, causing swelling and pain. Examples include rheumatoid arthritis or lupus.

Will I get one of the new RSV vaccines?

Yes, if you join the study, you will receive one of the RSV vaccines that are already approved and available.

What will happen during the study?

You'll have a blood test before getting the vaccine, then receive the vaccine, and have another blood test 3-6 weeks later to see how your body responded.

Will my regular medications for my rheumatic disease be affected?

The study aims to see how your current anti-rheumatic treatments affect vaccine response; your treatment plan usually won't change for the study. This will be discussed with your doctor.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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