A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
研究概览
简要总结
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
60μg, 0-1
112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
干预措施: Hepatitis B vaccine (Biological)
20μg, 0-1-6
117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
干预措施: Hepatitis B vaccine (Biological)
60μg, 0-2
125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
干预措施: Hepatitis B vaccine (Biological)
结局指标
主要结局
Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
时间窗: one month after a series vaccination of the regimen
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.
次要结局
- Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults(2-year after the first dose of the regimens)
研究者
Xueen Liu
Dr.
Peking University