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

Beijing Municipal Science & Technology Commission

Status: Unknown

Conditions: Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT01441609

BJCDCWJ201103

Details and patient eligibility

About

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).

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 3 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

94 participants in 4 patient groups

the value of anti-HBs =0 mIU/ml

Description:

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

Description:

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

Description:

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

Description:

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.