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Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, August 2005
First Received: September 5, 2005   Last Updated: July 12, 2007   History of Changes
Sponsors and Collaborators: National Taiwan University Hospital
National Science Council, Taiwan
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00147459
  Purpose

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.


Condition Intervention
Liver Transplantation
Hepatitis B
Biological: HBV vaccine booster

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation

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

Estimated Enrollment: 50
Study Start Date: September 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who received liver transplantation > 1 year ago

Exclusion Criteria:

  • Are now in an unstable condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147459

Contacts
Contact: Yen H Ni, MD, PhD 886-2-23123456 ext 5451 yhni@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yen H Ni, MD, PhD     23123456 ext 5451        
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Yen H Ni, MD, PhD NTUH
  More Information

No publications provided

Study ID Numbers: 931205
Study First Received: September 5, 2005
Last Updated: July 12, 2007
ClinicalTrials.gov Identifier: NCT00147459     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
hepatitis B virus
vaccine
booster
liver transplantation

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

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

ClinicalTrials.gov processed this record on September 04, 2009