Study of B Cell Response to Tetanus Toxoid Vaccination in Patients with Systemic Sclerosis, Systemic Lupus Erythematosus, and Rheumatoid Arthritis

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What is this study about?

This clinical trial focuses on understanding immune system responses in patients with autoimmune diseases, specifically Systemic Sclerosis, Systemic Lupus Erythematosus, and Rheumatoid Arthritis. These conditions occur when the body’s immune system mistakenly attacks its own tissues. The study will use a Tetanus Toxoid vaccine, which is commonly used to protect against tetanus infection, to examine how the immune system responds in people with these conditions compared to healthy individuals.

The study aims to examine how specific immune cells called B cells respond to the tetanus vaccine in people with autoimmune diseases. Participants will receive a single booster shot of the tetanus vaccine as a suspension for injection into the muscle. The amount given will be 0.5 milliliters, which is a standard vaccine dose.

During the study, researchers will collect blood samples at different times to observe how the immune system responds to the vaccine. They will look at special immune cells and proteins in the blood before and after vaccination. This will help them understand the differences between how the immune system works in people with autoimmune diseases compared to people without these conditions.

1 Initial vaccination visit

You will receive a single tetanus toxoid booster vaccination through intramuscular injection

The vaccine contains 40 IU of tetanus toxoid in suspension form

A blood sample will be taken to establish baseline measurements

2 Follow-up blood sampling

Multiple blood samples will be collected at scheduled time points

The samples will be used to analyze:

– Changes in your B cells (immune system cells that produce antibodies)

– Levels of antibodies against tetanus toxoid

– Characteristics of antibodies in your blood

3 Study duration

The study period runs from October 2025 to September 2028

Your participation involves periodic visits for blood sampling throughout this period

The exact schedule of visits will be provided by the study team

4 Study completion

The study ends after the final blood sample collection

No further follow-up is required after the last visit

Your participation concludes automatically at this point

Who Can Join the Study?

  • Must be at least 18 years old
  • Must be able to understand the study information and sign a written consent form
  • Must be willing to receive a single booster shot of tetanus toxoid vaccine (a vaccine that helps protect against tetanus infection)
  • Must have previously completed the full initial series of tetanus vaccinations
  • Can be either male or female
  • Must have one of these conditions:
    • Systemic sclerosis (an autoimmune disease affecting skin and connective tissues)
    • Systemic lupus erythematosus (an autoimmune disease that can affect multiple organs)
    • Rheumatoid arthritis (an autoimmune disease causing joint inflammation)
  • Must not be part of any vulnerable population groups

Who Cannot Join the Study?

  • Active infection or ongoing treatment with antibiotics
  • Previous allergic reactions to vaccines or vaccine components
  • Received any vaccination in the past 3 months
  • Current pregnancy or breastfeeding
  • Severe kidney disease (impaired kidney function)
  • Severe liver disease (impaired liver function)
  • History of blood clotting disorders
  • Active cancer or ongoing cancer treatment
  • Taking medications that severely suppress the immune system (the body’s defense system)
  • Participation in another clinical trial within the last 30 days
  • Inability to provide informed consent
  • History of substance abuse in the past 12 months
  • Unstable or severe heart conditions
  • Uncontrolled high blood pressure
  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reaction)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Lftze Uzcfxzxjfjww Mkrextx Cabstqm (neyes Leiden The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.10.2025

Trial locations

Investigated drugs:

Tetanus Toxoid is a vaccine made from inactivated tetanus toxin. It stimulates the immune system to produce antibodies against tetanus. In this trial, it is used as a booster vaccination to activate specific immune cells (B cells) and study how they respond in people with autoimmune diseases compared to healthy individuals. This helps researchers understand how the immune system works differently in people with autoimmune conditions.

Investigated diseases:

Systemic sclerosis – A chronic autoimmune disease that causes hardening and tightening of the skin and connective tissues. It begins with inflammation and gradually leads to the buildup of scar tissue in the skin and various organs. The condition typically starts with skin changes in the fingers, hands, and face, and may progress to affect internal organs. The disease causes the immune system to attack the body’s own tissues, leading to tissue damage and fibrosis.

Systemic lupus erythematosus – A complex autoimmune disease where the immune system attacks various parts of the body, causing widespread inflammation. The condition can affect multiple organs and body systems, including the skin, joints, kidneys, and blood vessels. Symptoms often come and go in periods called flares and remissions. The disease commonly causes joint pain, skin rashes, and fatigue.

Rheumatoid arthritis – A chronic inflammatory disorder that primarily affects the joints, causing pain, stiffness, and swelling. The condition typically starts in smaller joints like fingers and toes, often affecting the same joints on both sides of the body. Over time, the persistent inflammation can lead to joint deformity and damage to the surrounding tissues. The disease occurs when the immune system mistakenly attacks the joint linings called synovium.

Trial ID:
2024-515312-50-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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