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临床试验/NCT01441609
NCT01441609Unknown不适用

Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination

Beijing Municipal Science & Technology Commission0 个研究点目标入组 94 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
94
主要终点
Th9 cells

研究概览

简要总结

An observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find out the expression levels of Th9 cells and IL9 in subjects with different response to the primary immunization (3 single -dose injunctions).

详细描述

This study selected 74 volunteers which had the hepatitis B vaccine (immunization programs 0,1,6) , anti-HBs≤10mIU as the research subjects, and choose 20 volunteers which anti-HBs≥1000mIU as the control group, revaccination the groups according to the normal immunization programs, then the blood samples would be collected at 7th day, separate the PBMC and detect the expression levels of Th9 cells and IL9 by FCM, trying to find out the effects of Th9 and IL9 of non/poor -responsiveness subjects to hepatitis B.

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

年龄范围
3 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • volunteer
  • between 3-60 years old
  • have the history of vaccination of hepatitis B.
  • Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative.
  • informed consent
  • not allergic to the component of the vaccine

排除标准

  • 未提供

结局指标

主要结局

Th9 cells

时间窗: blood sample of 7th day after each vaccination

次要结局

未报告次要终点

研究者

发起方
Beijing Municipal Science & Technology Commission
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Jiang

Director

Centers for Disease Control and Prevention

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