NCT00147459

Brief Summary

Aim/Background: This study aims to investigate the necessity and efficacy of a hepatitis B virus (HBV) vaccine booster in children after liver transplantation. A universal mass vaccination program of HBV was launched for 20 years in Taiwan. The coverage rate is high and the effect is great. The carrier rate of the population under vaccine coverage decreased from 10-15% to \< 1%. In Taiwan, most children who receive organ transplantation were vaccinated with HBV vaccine in infancy and well before the transplantation procedure. This vaccination background information on Taiwanese children is quite unique and not similar to the other countries in the world. The antibody generated by the vaccine usually wanes after a certain period even in normal subjects, let alone in subjects who receive organ transplantation and immunosuppressive agents after transplantation. At present, Taiwan is still an HBV hyperendemic area and the risk of exposure to HBV cannot be overlooked. Should children be given a booster dose of HBV vaccine after transplantation? And how about the immunogenicity of this booster dose in these immunocompromised hosts? If these children cannot obtain an adequate antibody titer, will the risk of HBV infection increase? This study is designed to answer these questions. As a pediatric hepatologist, the author's routine work is to take care of children who underwent liver transplantation. To take advantage of this, the investigators decided to study the efficacy and necessity of HBV booster vaccine in these patients. However, the results of this study should be able to be applied to any kind of solid organ transplanted patients. Method: The anti-hepatitis B surface antigen (HBs) titer will be checked in patients who received liver transplantation \> 1 year ago. If the titer is \< 10 IU/L, a booster dose will be administered. The humoral (anti-HBs) and cellular immunity (by ELISPOT to assay T and B cell specific proliferation) and cytokine assay will be done in these patients before and after the booster dose. A three-year follow-up will be performed to monitor the HBV infection in these patients. Expected Results: The investigators expect for those who survive one year more after liver transplantation to yield a relatively good response to HBV booster under adequate immunosuppression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

September 5, 2005

Last Update Submit

December 4, 2012

Conditions

Liver TransplantationHepatitis B

Keywords

hepatitis B virusvaccineboosterliver transplantation

Outcome Measures

Primary Outcomes (1)

  • Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation

    antibody(+)

    1 year

Secondary Outcomes (1)

  • The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation

    1 year

Study Arms (1)

booster

ACTIVE COMPARATOR

no antibody and boosted

Biological: HBV vaccine booster

Interventions

HBV vaccine boosterBIOLOGICAL
booster

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children who received liver transplantation \> 1 year ago

You may not qualify if:

  • Are now in an unstable condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yen H Ni, MD, PhD

    NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen H Ni, MD, PhD

CONTACT

886-2-23123456yhni@ha.mc.ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 7, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

TW(1)