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

NCT ID: NCT01441609

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Hepatitis B

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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the value of anti-HBs =0 mIU/ml

Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs be zero.

No interventions assigned to this group

the value of anti-HBs≤5mIU/ml

Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs≤5mIU/ml.

No interventions assigned to this group

5mIU≤anti-HBs≤10mIU/ml

Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of 5mIU≤anti-HBs≤10mIU

No interventions assigned to this group

anti-HBs≥1000mIU

Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative. had vaccinated hepatitis B vaccine and the value of anti-HBs≥1000mIU.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role lead

Responsible Party

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Wu Jiang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wu Jiang

Role: STUDY_DIRECTOR

main investigator

Locations

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Chifeng, Inner Mongolia, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li xuezhen

Role: CONTACT

0476-5891156

Other Identifiers

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BJCDCWJ201103

Identifier Type: -

Identifier Source: org_study_id