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

September 27, 2011 updated by: Wu Jiang, Beijing Municipal Science & Technology Commission

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

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 024000
        • Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

94 subjects divided into 4 groups

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
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.
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Th9 cells
Time Frame: blood sample of 7th day after each vaccination
blood sample of 7th day after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Municipal Science & Technology Commission

Investigators

  • Study Director: Wu Jiang, main investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

September 26, 2011

First Posted (Estimate)

September 27, 2011

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDCWJ201103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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