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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00702663
First received: June 18, 2008
Last updated: June 19, 2008
Last verified: June 2008
  Purpose
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.

Condition
Hepatitis B

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Seroprevalence of Hepatitis B Infection, Effect of Booster Response, and Significance of Anti-HBc Positivity Amongst Taiwanese Young Adults

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Biospecimen Retention:   Samples With DNA
Hepatitis B DNA

Estimated Enrollment: 1800
Study Start Date: October 2007
Estimated Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
18-20 year- old freshmen from a private university from northern Taiwan
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702663

Locations
Taiwan
Yuan Ze University
Taipei, Taiwan
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Fu-Hsiung Su, BMBS Far Eastern Memorial Hospital
  More Information

Responsible Party: Fu-Hsiung Su, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00702663     History of Changes
Other Study ID Numbers: 96035 
Study First Received: June 18, 2008
Last Updated: June 19, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
Hepatitis B
Hepatitis B vaccination
booster effect
Taiwan
young adults

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on December 09, 2016