Not yet recruitingRare disease

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 trial about?

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

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

9 criteria

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 trial?

15 criteria

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)

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

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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.

TETANUS TOXOID

What is already known about the treatment

Since there are no specific medications mentioned in the provided trial data, I can describe the Tetanus Toxoid (TT) vaccine which is referenced in the study: Tetanus Toxoid - A highly effective vaccine administered through intramuscular injection, which has been a standard part of immunization programs worldwide for decades. It works by stimulating the immune system to produce antibodies against tetanus toxin, providing protection against tetanus infection, with immunity typically lasting for several years after a complete vaccination series. The vaccine contains inactivated tetanus toxin (toxoid) that triggers B-cell response in the immune system, making it particularly relevant for this clinical trial studying B-cell responses in autoimmune conditions. This vaccine belongs to the toxoid vaccines pharmacological class and is considered one of the safest and most reliable vaccines in modern medicine.

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.