A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Hepatitis B surface antibody mIU/ml
研究概览
简要总结
Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis B vaccination.
In this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B surface antigen (HBsAg) vaccine given to predialysis CKD patients.
详细描述
In an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •predialysis patients,
- •> 18 years with mild and moderate chronic renal failure,
- •serum creatinine between 1.5-6 mg/dl
排除标准
- •patients with severe renal failure,
- •serum creatinine > 6 mg/dl,
- •requiring dialysis or expected to require dialysis within 1 year,
- •receiving immunosuppressive treatment,
- •known lymphoproliferative disorder.
结局指标
主要结局
Hepatitis B surface antibody mIU/ml
时间窗: 8-10 weeks after the 6-month dose of vaccine
Anti-HBs titres less than 10 mIU/ml were defined as non-seroconversion or non-responder. Anti-HBs titres greater than or equal to 10 mIU/ml but less than 100 mIU/ml were defined as seroconversion with low level antibody. Anti- HBs titres greater than or equal to100 mIU/ml were defined as seroconversion with protective levels of hepatitis B antibody.
次要结局
未报告次要终点
研究者
Zahra Khazaeipour
Principal Investigator, Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital.
Tehran University of Medical Sciences