Investigating the (autoreactive) B cell compartment in antibody-mediated autoimmune diseases in comparison with the recall Tetanus Toxoid response
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leids Universitair Medisch Centrum (LUMC)
- Trial code
- EU 2024-515312-50-00
- Record updated
- 2025. július 8.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: ≥ 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.
Exclusion: 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; 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 do not fulfill the classification criteria for the respective diagnoses, as set out in the inclusion criteria; 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 pregnant at the time of inclusion.