Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cluster of Differentiation (CD) 8+ CD 57+ CD 28- / CD 8+ T lymphocytes Ratio in Peripheral Blood
研究概览
简要总结
The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.
详细描述
The risk of infection with hepatitis B during exposure to blood is high (30% against 1.8% for Hepatitis C Virus and HIV 1%) and dialysis patients are a population at risk. Vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. However, numerous studies have shown that HBV vaccination was less effective in patients with chronic renal disease than in the general population. The reasons for low vaccine response are poorly understood. However, recent data suggest that renal failure could induce accelerated immunosenescence.
The aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. The gradual reduction of the generation of naive T cells in the thymus is the major cause of immunosenescence. But this process is also associated with an accumulation of lymphocytes at the end of differentiation.
In this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.
Vaccination against HBV is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. Included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the Health Authority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an indication of HBV vaccination
- •Patient with renal disease, with a creatinine clearance between 15 and 60ml/min
- •Patient who have never been vaccinated against HBV
- •Patient with negative serology for HBV
- •Patient able to understand the reason of the study
- •Patient not opposed to the conservation of biological samples for scientific research
排除标准
- •Patient infected with Hepatitis B or with history of vaccination against HBV
- •Patient suffering from psychotic illness
- •Patient with any history of immunosuppressive therapy
- •Patient with infectious and/or cancer diseases in evolution
研究组 & 干预措施
Chronic Renal Failure
Patients with renal failure, with creatinine clearance between 60 and 15 ml/min. A blood sample is achieved at 0, 1, 3 and 6 months.
干预措施: Blood sample (Biological)
结局指标
主要结局
Cluster of Differentiation (CD) 8+ CD 57+ CD 28- / CD 8+ T lymphocytes Ratio in Peripheral Blood
时间窗: 13 months
The primary outcome is assessed 1 month after the vaccination schedule. The percentage of CD 8+ and CD 8+ CD 28- CD 57+ lymphocytes were determined by flow cytometry.
次要结局
- Calculated Creatinine Clearance (Cockcroft-Gault Equation)(13 months)
- Percentage of Lymphocytes subpopulations in Peripheral Blood Mononuclear Cells(13 months)
- T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC)(13 months)
- Interferon gamma and Interleukin-10 production of Peripheral blood T lymphocytes(13 months)