Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 3
- 主要终点
- Frequency of serological response to influenza vaccination
研究概览
简要总结
The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.
Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.
Participants will:
- Be enrolled at the time of influenza vaccination
- Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination
- Be asked to provide relevant clinical information and a blood sample at each visit
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years
- •Patients undergoing thrice-weekly hemodialysis / peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency
- •Subjects eligible to receive a seasonal influenza vaccine
- •Signed informed consent for participation in the study
排除标准
- •Recent influenza infection (clinically resolved less than 3 months ago).
- •Administration of immunosuppressive drugs in the two weeks prior to vaccination.
- •Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).
- •Systemic infection clinically resolved less than two weeks before enrollment.
研究组 & 干预措施
Hemodialysis patients
Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis
干预措施: Influenza vaccination (Biological)
Peritoneal dialysis patients
Subjects with advanced chronic kidney disease on peritoneal dialysis
干预措施: Influenza vaccination (Biological)
Healthy controls
Subjects without a prior history of chronic kidney disease
干预措施: Influenza vaccination (Biological)
Healthy controls
Subjects without a prior history of chronic kidney disease
干预措施: SARS-CoV-2 vaccine (Biological)
Peritoneal dialysis patients
Subjects with advanced chronic kidney disease on peritoneal dialysis
干预措施: SARS-CoV-2 vaccine (Biological)
Hemodialysis patients
Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis
干预措施: SARS-CoV-2 vaccine (Biological)
结局指标
主要结局
Frequency of serological response to influenza vaccination
时间窗: From enrollment to 30±3 days after vaccination
次要结局
- Titer of influenza-specific antibodies after vaccination(From enrollment to 30±3 days after vaccination)
- Correlation between virus-specific antibody concentration after influenza vaccination and the frequency of circulating T follicular helper cell subsets(From enrollment to 120±5 days after vaccination)
- Degree of antigen-specific activation of T follicular helper and B cells in vitro after influenza vaccination(From enrollment to 120±5 days after vaccination)
- Degree of polyclonal activation of T follicular helper and B cells in vitro after exposure to the serum of subjects vaccinated against influenza(From enrollment to 120±5 days after vaccination)
- Single-cell transcriptome expression in circulating T follicular helper cell subsets(From enrollment to 120±5 days after vaccination)