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2024-515312-50-00Not yet recruitingPhase 4

Investigating the (autoreactive) B cell compartment in antibody-mediated autoimmune diseases in comparison with the recall Tetanus Toxoid response

Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
96 (estimated)
First submitted
23 Apr 2025
Start date
1 Oct 2025
Lead sponsor
Leids Universitair Medisch Centrum (LUMC)
EU CT number
2024-515312-50-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 96
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • 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

Who the study is looking for

  • ≥ 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Leids Universitair Medisch Centrum (LUMC)LeidenNetherlandsNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.