Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 主要终点
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
研究概览
简要总结
Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.
This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
详细描述
Comparison of 2 vaccination strategy against Hepatitis B in Drug Users
Intervention:
Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 3 : Receive no vaccination during the study period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years at the enrolment
- •current illicit drug users before drug rehabilitation
- •negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- •having spent acute physiological detoxification phase
排除标准
- •any intolerance or allergy to any component of the vaccine
- •ongoing opportunistic infection
- •liver disease
- •hemopathy
- •unexplained fever in the last week before the recruiting
结局指标
主要结局
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
时间窗: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
次要结局
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 12(Month 12)
- Anti-HBs Concentration at Month 7(Month 7)
- Occurrence of Adverse Events After Vaccination(Within 28 days after the vaccination, at Month 0, 1, and 6)
- Anti-HBs Concentration at Month 12(Month 12)
- Serious Adverse Events (SAE) Occurred During Month 12(Month 0-12)
研究者
Suping Wang
Professor
Shanxi Medical University