The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 主要终点
- Anti-HBs Seroconversion Rate at Months 1
研究概览
简要总结
The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.
This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.
详细描述
Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. 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
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged of 18 years or above
- •Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) 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
- •Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
研究组 & 干预措施
20 µg at month 0, months 0, 1 or 0, 1, and 6
20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6
干预措施: 20 µg dose hepatitis B vaccine (Biological)
结局指标
主要结局
Anti-HBs Seroconversion Rate at Months 1
时间窗: Months 1
Anti-HBs Seroconversion Rate at Months 1
Anti-HBs Seroconversion Rate at Months 3
时间窗: Months 3
Anti-HBs Seroconversion Rate at Months 3
Anti-HBs Seroconversion Rate at Months 7
时间窗: Months 7
Anti-HBs Seroconversion Rate at Months 7
Anti-HBs Seroconversion Rate at Months 12
时间窗: Months 12
Anti-HBs Seroconversion Rate at Months 12
Anti-HBs Seroconversion Rate at Months 18
时间窗: Months 18
Anti-HBs Seroconversion Rate at Months 18
Anti-HBs Seroconversion Rate at Months 24
时间窗: Months 24
Anti-HBs Seroconversion Rate at Months 24
Anti-HBs Seroconversion Rate at Months 30
时间窗: Months 30
Anti-HBs Seroconversion Rate at Months 30
次要结局
- Anti-HBs Concentration at Months 18(Months 18)
- Anti-HBs Concentration at Months 30(Months 30)
- Anti-HBs Concentration at Months 1(Months 1)
- Anti-HBs Concentration at Months 3(Months 3)
- Anti-HBs Concentration at Months 7(Months 7)
- Anti-HBs Concentration at Months 12(Months 12)
- Anti-HBs Concentration at Months 24(Months 24)
研究者
Suping Wang
Professor
Shanxi Medical University