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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515312-50-00
Enrollment
96
Registered
2025-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis, Systemic lupus erythematosus, Systemic sclerosis

Brief summary

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.

Detailed description

plasma levels and characteristics (e.g. glycosylation) of autoantibodies and anti-TT antibodies during different stages of activation of the underlying B cell responses., phenotype and dynamics of TT-specific B cells before and upon vaccination in healthy individuals.

Interventions

DRUGTetanusvaccin
DRUGsuspensie voor injectie 40 IE

Sponsors

Leids Universitair Medisch Centrum (LUMC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
plasma levels and characteristics (e.g. glycosylation) of autoantibodies and anti-TT antibodies during different stages of activation of the underlying B cell responses., phenotype and dynamics of TT-specific B cells before and upon vaccination in healthy individuals.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026