Tetanus toxoid for Systemic sclerosis | Systemic lupus erythematosus | Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- ≥ 18 years of age\n- able to understand the patient information form and to provide written informed consent.\n- willing to receive a single, one-time booster vaccination against tetanus toxoid.\n- having completed a primary vaccination regime against tetanus toxoid."}

Exclusion criteria

• {"criterion_text":"- who do not fulfill the classification criteria for the respective diagnoses, as set out in the inclusion criteria.\n- 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.\n- 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.\n- 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.).\n- who are or have been treated with specific B cell depleting/modifying therapies (Rituximab, Belimumab, Cyclophosphamide, Tocilizumab, Abatacept) within 12 months prior to inclusion.\n- with contraindications for a booster vaccination against tetanus toxoid: o\tHypersensitivity to the active substance(s) or to any of the excipients o\tSevere reaction after previous administration with the same vaccine\n- who received a TT vaccination or booster within the past 24 months prior to inclusion.\n- who are pregnant at the time of inclusion"}

Primary endpoints

• {"endpoint_text":"- the frequency and phenotype of antigen-specific, autoreactive B cells in the peripheral blood of patients at the indicated time-points, compared to the frequency and phenotype of TT-specific B cells prior to and upon booster vaccination, at the same timepoints. Assessment will be done by flow cytometry, generating a phenotypic profile rather than a single parameter.","definition_or_measurement_approach":"Assessment will be done by flow cytometry, generating a phenotypic profile rather than a single parameter."}

Secondary endpoints

• {"endpoint_text":"- plasma levels and characteristics (e.g. glycosylation) of autoantibodies and anti-TT antibodies during different stages of activation of the underlying B cell responses.","definition_or_measurement_approach":"Measured in plasma; characteristics include e.g. glycosylation (as stated)."}
• {"endpoint_text":"- phenotype and dynamics of TT-specific B cells before and upon vaccination in healthy individuals.","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

27-06-2025

Latest Decision Or Authorization Date

08-07-2025

Processing Time Days

11

Number Of Sites

1

Number Of Participants

96

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands