Impact of the Lack of CMV-Specific CD8+ T Cell Response in CMV-Seropositive Donors in CMV Reactivation After Hematopoietic Stem Cells Transplant in CMV-Seropositive Recipients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response [D+(T-)/R+] in comparison with D+(T+)/R+ and D-/R+ patients
研究概览
简要总结
Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients since it is considered that patients also have specific cellular immunity against CMV. However, investigators group has published that around 25% of solid organ transplant candidates lack CMV-specific CD8+ T-cell response ("humoral/cellular mismatch") and they are at a higher risk of CMV replication after transplantation. The main goal of this study is to analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in CMVseropositive recipients. Investigators will study not only the incidence of CMV reactivation but also the severity (duration and peak viral load), CMV disease and survival. CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de Valdecilla Hospital (Santander).
Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution will be determined using QuantiFERON-CMV assay.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CMV Seropositive patients who receive a HSCT (Bone marrow or peripheral) blood from related donors
- •>14 years old
- •signed Inform consent form
排除标准
- •HIV, HCV, HBV Infection
结局指标
主要结局
To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response [D+(T-)/R+] in comparison with D+(T+)/R+ and D-/R+ patients
时间窗: During the 6 months after transplantation
To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response \[D+(T-)/R+\] in comparison with D+(T+)/R+ and D-/R+ patients
次要结局
- To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)](3 years)
- To evaluate the incidence of CMV disease as well as the type and severity of the disease in D+(T-)/R+ vs D-/R+ and D+(T+)/R+ patients(3 years)
- CMV-specific immune reconstitution: Units (Percentage respect to CD8+ T cells) and interferon-gamma production (IU/mL).(3 years)
- Innate and adaptive immune reconstitution: Units (percentage and absolute number)(3 years)