Effect of the Expression Level of Th9 Cells and IL-9 In Poor/Non-responsiveness to Hepatitis B Vaccination
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 94
- Primary Endpoint
- Th9 cells
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
Eligibility Criteria
- Ages
- 3 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •volunteer
- •between 3-60 years old
- •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
Outcomes
Primary Outcomes
Th9 cells
Time Frame: blood sample of 7th day after each vaccination
Secondary Outcomes
No secondary outcomes reported
Investigators
Wu Jiang
Director
Centers for Disease Control and Prevention