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Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Primary Purpose

Liver Transplantation, Hepatitis B

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HBV vaccine booster
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Transplantation focused on measuring hepatitis B virus, vaccine, booster, liver transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children who received liver transplantation > 1 year ago Exclusion Criteria: Are now in an unstable condition

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

booster

Arm Description

no antibody and boosted

Outcomes

Primary Outcome Measures

Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation
antibody(+)

Secondary Outcome Measures

The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation
if no antibody , booster

Full Information

First Posted
September 5, 2005
Last Updated
December 4, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00147459
Brief Title
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
Official Title
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

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.
Detailed Description
The anti-HBs titer will be checked in the patients who received liver transplantation for > 1 year. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Hepatitis B
Keywords
hepatitis B virus, vaccine, booster, liver transplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
booster
Arm Type
Active Comparator
Arm Description
no antibody and boosted
Intervention Type
Biological
Intervention Name(s)
HBV vaccine booster
Primary Outcome Measure Information:
Title
Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation
Description
antibody(+)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation
Description
if no antibody , booster
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children who received liver transplantation > 1 year ago Exclusion Criteria: Are now in an unstable condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen H Ni, MD, PhD
Phone
886-2-23123456
Ext
5451
Email
yhni@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen H Ni, MD, PhD
Organizational Affiliation
NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen H Ni, MD, PhD
Phone
23123456
Ext
5451

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

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