Clinical trial NCT01973582: Hepatitis B Seroepidemiology Among Young Adults
Official title: A Retrospective Cohort Study of Hepatitis B Seroepidemiology Among Young Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: Hepatitis B
epidemiology
youth
vaccine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-10-31
Enrollment: 6000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults 20 to 30 years old.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Young adults 20 to 30 years old.

Exclusion Criteria:

* Refused to undergo blood draw or questionaire.

Primary outcomes:
measure: serostatus of hepatitis B viral markers
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chyi-Feng Jan, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1093/epirev/mxj010. Epub 2006 Jun 16.