Expression of Th9 Cells and Poor/Non-responsiveness to Hepatitis B Vaccination
Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination
1 other identifier
observational
94
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 28, 2011
September 1, 2011
8 months
September 26, 2011
September 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Th9 cells
blood sample of 7th day after each vaccination
Study Arms (4)
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.
Eligibility Criteria
94 subjects divided into 4 groups
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Chifeng, Inner Mongolia, 024000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wu Jiang
main investigator
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 26, 2011
First Posted
September 27, 2011
Study Start
August 1, 2011
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
September 28, 2011
Record last verified: 2011-09