Investigating the (autoreactive) B cell compartment in antibody-mediated autoimmune diseases in comparison with the recall Tetanus Toxoid response
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •≥ 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.
排除标准
- •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
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
H.U. Scherer
Scientific
Leids Universitair Medisch Centrum (LUMC)