The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
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.
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Suping Wang, PhD
- 电话号码：+86-351-4135103
- 邮箱：supingwang@sxmu.edu.cn
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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
|
one-dose, two-dose or three-dose, 20 µg per dose
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anti-HBs Seroconversion Rate at Months 1
大体时间：Months 1
|
Anti-HBs Seroconversion Rate at Months 1
|
Months 1
|
|
Anti-HBs Seroconversion Rate at Months 3
大体时间：Months 3
|
Anti-HBs Seroconversion Rate at Months 3
|
Months 3
|
|
Anti-HBs Seroconversion Rate at Months 7
大体时间：Months 7
|
Anti-HBs Seroconversion Rate at Months 7
|
Months 7
|
|
Anti-HBs Seroconversion Rate at Months 12
大体时间：Months 12
|
Anti-HBs Seroconversion Rate at Months 12
|
Months 12
|
|
Anti-HBs Seroconversion Rate at Months 18
大体时间：Months 18
|
Anti-HBs Seroconversion Rate at Months 18
|
Months 18
|
|
Anti-HBs Seroconversion Rate at Months 24
大体时间：Months 24
|
Anti-HBs Seroconversion Rate at Months 24
|
Months 24
|
|
Anti-HBs Seroconversion Rate at Months 30
大体时间：Months 30
|
Anti-HBs Seroconversion Rate at Months 30
|
Months 30
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anti-HBs Concentration at Months 1
大体时间：Months 1
|
Anti-HBs Concentration at Months 1
|
Months 1
|
|
Anti-HBs Concentration at Months 3
大体时间：Months 3
|
Anti-HBs Concentration at Months 3
|
Months 3
|
|
Anti-HBs Concentration at Months 7
大体时间：Months 7
|
Anti-HBs Concentration at Months 7
|
Months 7
|
|
Anti-HBs Concentration at Months 12
大体时间：Months 12
|
Anti-HBs Concentration at Months 12
|
Months 12
|
|
Anti-HBs Concentration at Months 18
大体时间：Months 18
|
Anti-HBs Concentration at Months 18
|
Months 18
|
|
Anti-HBs Concentration at Months 24
大体时间：Months 24
|
Anti-HBs Concentration at Months 24
|
Months 24
|
|
Anti-HBs Concentration at Months 30
大体时间：Months 30
|
Anti-HBs Concentration at Months 30
|
Months 30
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Occurrence of Adverse Events After Vaccination
大体时间：Within 7 days after the vaccination
|
Occurrence of Adverse Events After Vaccination
|
Within 7 days after the vaccination
|
|
Occurrence of Adverse Events After Vaccination
大体时间：Within 28 days after vaccination
|
Occurrence of Adverse Events After Vaccination
|
Within 28 days after vaccination
|
合作者和调查者
调查人员
- 首席研究员：Suping Wang, PhD、Shanxi Medical University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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