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Hepatitis BNCT00702663

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

An observational study of Hepatitis B, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B
How many people
1,800 participants
Where
1 siteTaiwan
Study dates
Oct 2007to Oct 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 18-20 year- old freshmen from a private university from northern Taiwan

Who may be able to join

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

Who cannot join

  • 18-20 years old college new entrants who did not complete a 4-dose HB vaccination in their infancy

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Yuan Ze University

    Taipei

    Fu-Hsiung Su, BMBS, 886-2-8966-7000 ext. 4206, williamsufh1@yahoo.com.tw

    Fu-Hsiung Su, BMBS

    Recruiting

Other trials in Taiwan

About this study

Official title: Seroprevalence of Hepatitis B Infection, Effect of Booster Response, and Significance of Anti-HBc Positivity Amongst Taiwanese Young Adults

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.

Read the 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.

Conditions
Hepatitis B
Keywords
Hepatitis B, Hepatitis B vaccination, booster effect, Taiwan, young adults
Medical subject headings
Hepatitis B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2008 (estimated)
  2. Study startOct 2007
  3. Study completionOct 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00702663
Sponsor's protocol ID
96035
Status last verified
Jun 2008
First submitted
18 Jun 2008
Last updated
20 Jun 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fu-Hsiung Su, BMBS (886-2-8966-7000 ext. 4206, williamsufh1@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008.

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