Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 主要终点
- Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7
研究概览
简要总结
Uptake, adherence, and completion of vaccination among HIV-infected adults 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 HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.
This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.
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
- Triple (Participant, Care Provider, 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
- •HIV-infected
- •Aged between 18 and 70 years
- •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 before or during the month preceding enrollment
- •Any Intolerance or allergy to any component of the vaccine
- •Ongoing opportunistic infection
- •Hematological disorder
- •Unexplained fever the week before enrollment
- •Immunosuppressive or immunomodulating treatment in the last six months
- •Liver disease
结局指标
主要结局
Number and Percentage 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)
- Anti-HBs Concentration at Month 7(Month 7)
- Serious Adverse Events (SAE) Occurred During 42 Month(Month 0-42)
- Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12(Month 12)
- Occurrence of Adverse Events After Vaccination(Within 28 days after vaccination)
研究者
Suping Wang
Professor
Shanxi Medical University