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

This study is currently recruiting participants.
Verified September 2011 by Beijing Municipal Science & Technology Commission
Sponsor:
Information provided by (Responsible Party):
Wu Jiang, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01441609
First received: September 26, 2011
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

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).


Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Municipal Science & Technology Commission:

Primary Outcome Measures:
  • Th9 cells [ Time Frame: blood sample of 7th day after each vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

94 subjects divided into 4 groups

Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441609

Contacts
Contact: Li xuezhen 0476-5891156

Locations
China, Inner Mongolia
Recruiting
Chifeng, Inner Mongolia, China, 024000
Sponsors and Collaborators
Beijing Municipal Science & Technology Commission
Investigators
Study Director: Wu Jiang main investigator
  More Information

No publications provided

Responsible Party: Wu Jiang, Director, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01441609     History of Changes
Other Study ID Numbers: BJCDCWJ201103
Study First Received: September 26, 2011
Last Updated: September 27, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Municipal Science & Technology Commission:
Th9 cells
IL9
non/poor responsiveness to hepatitis B
collect blood samples after vaccination

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 21, 2013