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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01441609
• Other study ID #: BJCDCWJ201103
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2011
• Last updated: September 27, 2011
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2011
• Source: Beijing Municipal Science & Technology Commission
• Contact: Li xuezhen
• Phone: 0476-5891156
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Th9 cells		blood sample of 7th day after each vaccination	No