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Investigating the (autoreactive) B cell compartment in antibody-mediated autoimmune diseases in comparison with the recall Tetanus Toxoid response
EU CTIS ID: 2024-515312-50-00
What this study is testing
To induce, by booster vaccination, the activation of TT-specific B cells in order to compare the autoreactive B cell compartment with the resting and activated TT-specific B cell compartment over time in patients with autoimmune diseases and healthy individuals.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 18 years of age
- able to understand the patient information form and to provide written informed consent.
- willing to receive a single, one-time booster vaccination against tetanus toxoid.
- having completed a primary vaccination regime against tetanus toxoid.
You likely can't join if
- who do not fulfill the classification criteria for the respective diagnoses, as set out in the inclusion criteria.
- individuals unwilling to provide sufficient information on their current health status required to assess eligibility, with the most relevant information being the presence/absence or prior history of an autoimmune disease, vaccination history, or the current or recent use of immunosuppressive drugs.
- for whom the treating physician considers that relevant safety issues apply (such as, for example, severe anemia) that preclude the provision of the required amount of peripheral blood projected for the study.
- who need to donate 50 mL of blood (or more) during the first four weeks of the study for any reason other than participation in the study (such as routine clinical care, participation in another study, blood donations for the blood bank, etc.).
- who are or have been treated with specific B cell depleting/modifying therapies (Rituximab, Belimumab, Cyclophosphamide, Tocilizumab, Abatacept) within 12 months prior to inclusion.
- with contraindications for a booster vaccination against tetanus toxoid: o Hypersensitivity to the active substance(s) or to any of the excipients o Severe reaction after previous administration with the same vaccine
See the full eligibility criteria
- ≥ 18 years of age
- able to understand the patient information form and to provide written informed consent.
- willing to receive a single, one-time booster vaccination against tetanus toxoid.
- having completed a primary vaccination regime against tetanus toxoid.
- who do not fulfill the classification criteria for the respective diagnoses, as set out in the inclusion criteria.
- individuals unwilling to provide sufficient information on their current health status required to assess eligibility, with the most relevant information being the presence/absence or prior history of an autoimmune disease, vaccination history, or the current or recent use of immunosuppressive drugs.
- for whom the treating physician considers that relevant safety issues apply (such as, for example, severe anemia) that preclude the provision of the required amount of peripheral blood projected for the study.
- who need to donate 50 mL of blood (or more) during the first four weeks of the study for any reason other than participation in the study (such as routine clinical care, participation in another study, blood donations for the blood bank, etc.).
- who are or have been treated with specific B cell depleting/modifying therapies (Rituximab, Belimumab, Cyclophosphamide, Tocilizumab, Abatacept) within 12 months prior to inclusion.
- with contraindications for a booster vaccination against tetanus toxoid: o Hypersensitivity to the active substance(s) or to any of the excipients o Severe reaction after previous administration with the same vaccine
- who received a TT vaccination or booster within the past 24 months prior to inclusion.
- who are pregnant at the time of inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.