Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 主要终点
- Anti-HBs Seroconversion Rate at Month 7
研究概览
简要总结
Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.
详细描述
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. 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
- •Having end-stage renal disease (ESRD) on maintenance hemodialysis
- •Aged between 18 and 70 years at enrollment
- •Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- •Willing to adhere to the study protocol
排除标准
- •Being pregnant
- •Acute cytolysis in the last three months before enrollment
- •Any vaccination during the month preceding enrollment
- •Intolerance or allergy to any component of the vaccine
- •Ongoing opportunistic infection
- •Hepatitis C virus infection
- •Hematological disorder
- •Unexplained fever the week before enrollment
- •Immunosuppressive or immunomodulating treatment in the last six months
- •Renal transplantation or upcoming renal transplantation
- •Liver disease
- •Other immunocompromised condition not related to ESRD
- •An expected survival of < 6 months
结局指标
主要结局
Anti-HBs Seroconversion Rate at Month 7
时间窗: Month 7
次要结局
- Anti-HBs Seroconversion Rate at Month 30(Month 30)
- Anti-HBs Seroconversion Rate at Month 24(Month 24)
- Anti-HBs Concentration at Month 12(Month 12)
- Occurrence of Adverse Events After Vaccination(Within 28 days after the vaccination)
- Anti-HBs Seroconversion Rate at Month 18(Month 18)
- Anti-HBs Seroconversion Rate at Month 42(Month 42)
- Anti-HBs Concentration at Month 7(Month 7)
- Anti-HBs Seroconversion Rate at Month 36(Month 36)
- Anti-HBs Seroconversion Rate at Month 12(Month 12)
研究者
Suping Wang
Professor
Shanxi Medical University