A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Beijing、中国、100191
- Peking University
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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:
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Exclusion Criteria:
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
- Chronic diseases: hepatitis, tumor, tuberculosis,et.al
- Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
- Subjects had a medical history of serious adverse reactions to vaccines
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：20μg, 0-1-6
117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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实验性的：60μg, 0-1
112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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实验性的：60μg, 0-2
125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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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 |
|---|---|---|
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Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
大体时间：one month after a series vaccination of the regimen
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. |
one month after a series vaccination of the regimen
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
大体时间：1-year after the first dose of the regimens
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs will be compared among the three vaccine groups. |
1-year after the first dose of the regimens
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Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
大体时间：2-year after the first dose of the regimens
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years. |
2-year after the first dose of the regimens
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
大体时间：0-3 day after the first dose of immunization
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Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days.
Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.
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0-3 day after the first dose of immunization
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合作者和调查者
合作者
调查人员
- 研究主任：Zhongliao Fang, Dr.、Guangxi provincial center for desease control and prevention
- 研究主任：Hui Zhuang, Dr.、Peking University Health Science Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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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