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Seroprevalence of Hepatitis B Infection and Effect of Booster Response Amongst Taiwanese Young Adults

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ClinicalTrials.gov Identifier: NCT00702663
Recruitment Status : Unknown
Verified June 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2008
Last Update Posted : June 20, 2008
Sponsor:
Information provided by:
Far Eastern Memorial Hospital

Tracking Information
First Submitted Date June 18, 2008
First Posted Date June 20, 2008
Last Update Posted Date June 20, 2008
Study Start Date October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Seroprevalence of Hepatitis B Infection and Effect of Booster Response Amongst Taiwanese Young Adults
Official Title Seroprevalence of Hepatitis B Infection, Effect of Booster Response, and Significance of Anti-HBc Positivity Amongst Taiwanese Young Adults
Brief Summary The aim of this study is to observe and evaluate initiate serum anti-HBs titers during entrance health examination among undergraduate freshmen in a university who showed a complete 4-dose HBV vaccination in infancy and whose serum status was (1) HBsAg negative and anti-HBc negative and (2) anti-HBc positive alone. For those students whose anti-HBs <10 mIU/ml, additional HBV vaccination boosters were given according to routine governmental suggested schedules. The anamnestic effect then is observed in both groups. The results of this study may contribute to the analysis of the effectiveness of anti-HBV vaccination twenty years after the commencement of the program and the necessity of initiating HBV booster program among Taiwanese young adults.
Detailed Description

Hepatitis-B virus infection is endemic in Taiwan with 90% of the adult population having been previously infected with HBV at some stage in their lives, and with approximately 15 - 20% of the general population being carriers of HBV surface antigen at time of writing. In 1984, Taiwan implemented a hepatitis-B vaccination program for high risk newborns. In 1986, the program was extended to all newborns. At the commencement of the program, the HBV carrier rate amongst children was 9.8 percent. Subsequently, from later reports (namely from the 5-, 10-, 15-, 16-,18-, and 20-year post mass HBV vaccination program commencement follow-up studies), the HBV infection and carrier rates would appear to have been declining continuously. However, the long-term efficacy of such vaccination still has remained as one of the main points of interests amongst Taiwan's public-health officials.

Previous researches indicated that hepatitis B surface antibody (HBsAb) acquired from vaccination would decline over time. However, whether the decline of HBsAb implicated loss of protection to hepatitis B infection remained controversial. Reports pertaining to previously immunized healthcare worker (HCW) found that protective HBsAb still persisted in 76% and 52% of HCW after 3 and 13 years respectively. Anamnestic response was also observed, though the study population were limited. Hepatitis B vaccination has been documented to provide protection to HBV infection for at least 15 years for various age groups. Those who were younger than 4 years had the most pronounced decline or protective HBsAb.

Our previous observations have demonstrated that the implementation of the HBV vaccination program since 1984 had reduced the transmission of HBV in Taiwan. However, an increase of prevalence rate of HBV natural infection (anti-HBc positivity) in 1987 cohort, which may suggest the possibility of protection of HBV mass vaccination has gradually decreasing through years. The waning-off of serum anti-HBs level to no protective level among half of our student population has occurred eighteen years after mass vaccination. As a result, the aim of this study is to observe and evaluate initiate serum anti-HBs titers during entrance health examination among undergraduate freshmen in a university who showed a complete 4-dose HBV vaccination in infancy and whose serum status was (1) HBsAg negative and anti-HBc negative and (2) anti-HBc positive alone. For those students whose anti-HBs <10 mIU/ml, additional HBV vaccination boosters were given according to routine governmental suggested schedules. The anamnestic effect then is observed in both groups. The results of this study may contribute to the analysis of the effectiveness of anti-HBV vaccination twenty years after the commencement of the program and the necessity of initiating HBV booster program among Taiwanese young adults.

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Hepatitis B DNA
Sampling Method Non-Probability Sample
Study Population 18-20 year- old freshmen from a private university from northern Taiwan
Condition Hepatitis B
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†19,¬†2008)
1800
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • 18-20 years old college new entrants who had complete 4-dose HB vaccination in their infancy

Exclusion Criteria:

  • 18-20 years old college new entrants who did not complete a 4-dose HB vaccination in their infancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 20 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00702663
Other Study ID Numbers 96035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fu-Hsiung Su, Far Eastern Memorial Hospital
Study Sponsor Far Eastern Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Fu-Hsiung Su, BMBS Far Eastern Memorial Hospital
PRS Account Far Eastern Memorial Hospital
Verification Date June 2008