Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00147459
First received: September 5, 2005
Last updated: December 4, 2012
Last verified: December 2012
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    antibody(+)


Secondary Outcome Measures:
  • The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    if no antibody , booster


Estimated Enrollment: 31
Study Start Date: September 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: booster
no antibody and boosted
Biological: HBV vaccine booster

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00147459     History of Changes
Other Study ID Numbers: 931205
Study First Received: September 5, 2005
Last Updated: December 4, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014