Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Anti-HBs Seroconversion Rate at Month 7
研究概览
简要总结
At present, chronic kidney disease population are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1, 2, and 6 in chronic kidney disease population.
详细描述
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Aged between 18 and 70 years at the enrolment
- •Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
- •Sign informed consent, willing to participate in this study
排除标准
- •Being pregnant
- •Intolerance or allergy to any component of the vaccine
- •Any vaccination during the month preceding enrollment
- •Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- •Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive
研究组 & 干预措施
20 µg at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
干预措施: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 (Biological)
20 µg at months 0, 1, 2,and 6
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
干预措施: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6 (Biological)
60 µg at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
干预措施: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6 (Biological)
结局指标
主要结局
Anti-HBs Seroconversion Rate at Month 7
时间窗: Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
次要结局
- Anti-HBs concentration at month 7(Month 7)
- Anti-HBs Concentration at Month 12(Month 12)
- Occurrence of Adverse Events After Vaccination(Within 7 days after the vaccination)
- Anti-HBs Concentration at Month 30(Month 30)
- Anti-HBs Concentration at Month 42(Month 42)
- Anti-HBs Seroconversion Rate at Month 18(Month 18)
- Anti-HBs Concentration at Month 18(Month 18)
- Anti-HBs Seroconversion Rate at Month 30(Month 30)
- Anti-HBs Seroconversion Rate at Month 12(Month 12)
- Anti-HBs Seroconversion Rate at Month 42(Month 42)
研究者
Suping Wang
Professor
Shanxi Medical University