Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 主要终点
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
研究概览
简要总结
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 methadone maintenance treatment patients.
详细描述
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment
Intervention:
Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;
Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
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) and hepatitis B surface antibody (anti-HBs) at enrollment
- •Willing to adhere to the study protocol
排除标准
- •Being pregnant
- •Intolerance or allergy to any component of the vaccine
- •Any vaccination during the month preceding enrollment
- •Ongoing opportunistic infection
- •Liver disease
- •Hematological disorder
- •Unexplained fever the week before enrollment
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
- Anti-HBs Concentration at Month 12(Month 12)
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 12(Month 12)
- Anti-HBs Concentration at Month 18(Month 18)
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 18(Month 18)
- Occurrence of Adverse Events After Vaccination(Within 28 days after the vaccination, at Month 0, 1, and 6)
- Anti-HBs Concentration at Month 42(Month 42)
- Anti-HBs Concentration at Month 7(Month 7)
- Anti-HBs Concentration at Month 30(Month 30)
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 42(Month 42)
- Number and Rate of Participants With Anti-HBs Seroconversion at Month 30(Month 30)
研究者
Suping Wang
Professor
Shanxi Medical University