HHV-6-specific T-cell Reconstitution Among Children and Adolescents After Allogeneic Stem.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 主要终点
- CD4+ patients after allogeneic HSCT
研究概览
简要总结
Human herpesvirus 6 (HHV-6) causes only minor symptoms in healthy individuals but in immunosuppressed patients, e.g., patients after allogeneic stem cell transplantation (HSCT), HHV-6 reactivations can lead to diseases in different organ systems. HHV-6 reactivations have also been reported to be a cause for delayed engraftment, a trigger of graft-versus-host disease and a co-factor for other virus reactivations. T-lymphocytes play an important role in the control of virus reactivations. Little is known about the development of virus-specific T-cells after allogeneic HSCT.
详细描述
Background:
Human herpesvirus 6 (HHV-6) causes only minor symptoms in healthy individuals but in immunosuppressed patients, e.g., patients after allogeneic stem cell transplantation (HSCT), HHV-6 reactivations can lead to diseases in different organ systems. HHV-6 reactivations have also been reported to be a cause for delayed engraftment, a trigger of graft-versus-host disease and a co-factor for other virus reactivations. T-lymphocytes play an important role in the control of virus reactivations. Little is known about the development of virus-specific T-cells after allogeneic HSCT.
Objective:
The aim of this study was the description of the HHV-6 specific cellular immunity in children and adolescents after allogeneic HSCT in the context of the clinical course.
Study design and participants:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have undergone allogeneic SCT (stem cell transplantation) at one of the participating centers in the last 24 months or who will undergo allogeneic SCT during the study period (up to 3 months before the end of the study) and complete follow-up care at the respective centers
- •Age> 1 year
- •Written consent by participant or legal guardian
排除标准
- •severe SCT-associated complications during the study period: Rejection of the transplant ("graft failure") severe graft-versus-host disease (GVHD grade 3 or 4)
- •Relapse of the (malignant) underlying disease or occurrence of another complication (e.g. secondary malignancy), which represents an indication for cytotoxic chemotherapy (or re-transplantation) during the examination period.
结局指标
主要结局
CD4+ patients after allogeneic HSCT
时间窗: 24 month
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54 of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) in both
CD8+ controls
时间窗: 1 day
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
CD8+ patients after allogeneic HSCT
时间窗: 24 month
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
CD4+ controls
时间窗: 1 day
secretion of IL-2, IFN-γ as well as TNF-α (single cytokines and in combination) i T-cells after stimulation with the HHV-6 specific antigen U54
次要结局
未报告次要终点