NCT00792610

Brief Summary

At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 24, 2009

Completed
Last Updated

October 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

November 16, 2008

Results QC Date

August 16, 2009

Last Update Submit

October 5, 2009

Conditions

Hepatitis B

Keywords

youthhepatitis Bvaccinationboosterimmunity response

Outcome Measures

Primary Outcomes (1)

  • Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)

    The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.

    7 months

Study Arms (1)

Hepatitis B booster

EXPERIMENTAL

They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.

Biological: hepatitis B vaccine

Interventions

hepatitis B vaccineBIOLOGICAL

Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.

Also known as: Engerix-B
Hepatitis B booster

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-23 years
  • the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.
  • Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent.
  • Participants are willing to receive 3 doses of Hepatitis B vaccines without payment.
  • General condition is in good health judged by the doctor

You may not qualify if:

  • Allergy to Hepatitis B vaccines or yeast
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B VaccinesEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Limitations and Caveats

The possible presence of T cell memory among the seronegative patients for HBsAg(+), anti-HBc(+), and anti-HBs(+) could be a concern.

Results Point of Contact

Title
Jan, Chyi-Feng
Organization
National Taiwan University Hospital
jcf036@ntu.edu.tw
886-2-23562147

Study Officials

  • Chyi-Feng Jan, Doctor

    National Taiwan University Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2008

First Posted

November 18, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

October 6, 2009

Results First Posted

September 24, 2009

Record last verified: 2009-08

Locations

TW(1)