Hepatitis B Seroepidemiology Among Young Adults

Hepatitis B Clinical Trial

Official title:

A Retrospective Cohort Study of Hepatitis B Seroepidemiology Among Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973582
• Other study ID #: 201012127RB
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2013
• Last updated: October 25, 2013
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: Chyi-Feng JAN, M.D.,Ph.D.
• Phone: 886-2-23123456
• Email: jcf036[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1, 1984. It successfully decreased the incidence of hepatitis B virus infection, the hepatitis B carrier rate as well as liver diseases among children and adolescents. The sexual transmission route is another important way of hepatitis B infection aside from the mother and child vertical infection, especially for youth and adults. Hepatitis B vaccination cohort refers to those who were born after 1986 and received hepatitis B vaccine immunization during newborn period. They are gradually entering into young adults and adolescent age. Among them, there is no empirical evidence to show the actual infection rate and to help implement hepatitis B vaccine booster policy for those who had three seronegative viral markers of hepatitis B. Therefore, the study design is to collect three consecutive years graduate school students school entry health examination data and undergo three hepatitis B viral markers checkup and blood types. The data linkage includes their health checkup data in the freshmen period, Taiwan CDC databank for neonatal hepatitis B immunization records, pregnancy and birth record registry, Taiwan cancer registry and Taiwan death record registry.

Description:

This study is aimed to delineate the hepatitis B seroepidemiology among young adults with or without neonatal hepatitis B immunization, among young adults with hepatitis B booster in the university period, among the mothers of hepatitis B vaccination cohort. The results of this study will provide important information to help government implement hepatitis B vaccine booster policy in the adolescents and young adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Young adults 20 to 30 years old.

Exclusion Criteria:

• Refused to undergo blood draw or questionaire.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chien YC, Jan CF, Kuo HS, Chen CJ. Nationwide hepatitis B vaccination program in Taiwan: effectiveness in the 20 years after it was launched. Epidemiol Rev. 2006;28:126-35. Epub 2006 Jun 16. Review. — View Citation

Jan CF, Huang KC, Chien YC, Greydanus DE, Davies HD, Chiu TY, Huang LM, Chen CJ, Chen DS. Determination of immune memory to hepatitis B vaccination through early booster response in college students. Hepatology. 2010 May;51(5):1547-54. doi: 10.1002/hep.23543. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serostatus of hepatitis B viral markers		One year	No