Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients, Does it Works?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Hepatitis B virus Seroprotection after one month
研究概览
简要总结
The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age was above 18 years
- •Hemodialysis patient
- •All patients had undetectable hepatitis B virus surface antigen and antibody
排除标准
- •A positive serum hepatitis B virus surface antigen and antibody
- •patient received a previous course of hepatitis B virus vaccine
研究组 & 干预措施
Hepatitis B recombinant DNA vaccine
Each Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six.
干预措施: Hepatitis B recombinant DNA vaccine (Drug)
Combined hepatitis A and B vaccine
Each one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21.
干预措施: Combined hepatitis A and B vaccine (Drug)
结局指标
主要结局
Hepatitis B virus Seroprotection after one month
时间窗: one month after third dose of the vaccine
Hepatitis B virus surface antibodies titer after one month
Hepatitis B virus Seroprotection after three months
时间窗: three months after third dose of the vaccine
Hepatitis B virus surface antibodies titer after three month
次要结局
- Pain scale(1 Hour after each vaccination dose)
- Fever(4 Days after each vaccination dose)
研究者
Mahmoud Hamada imam
MD. - Lecturer at Internal Medicine Department- Faculty of Medicine
Benha University