Expression of Th9 Cells and Poor/Non-responsiveness to Hepatitis B Vaccination

• Conditions: Hepatitis B

• Registration Number: NCT01441609
• Lead Sponsor: Beijing Municipal Science & Technology Commission

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2011-08
• Status Verified: 2011-09
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-27
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28
• Primary Completion: 2012-04
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• volunteer
• between 3-60 years old
• healthy
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Th9 cells	blood sample of 7th day after each vaccination