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Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00147459
Recruitment Status : Unknown
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2005
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE September 5, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE September 2005
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation [ Time Frame: 1 year ]
antibody(+)
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2005)
Persistence of anti-HBs in those primarily vaccinated and underwent liver transplantation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation [ Time Frame: 1 year ]
if no antibody , booster
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2005)
The necessity of booster dose of HBV vaccine for those primarily vaccinated and underwent liver transplantation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
Official Title  ICMJE Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Liver Transplantation
  • Hepatitis B
Intervention  ICMJE Biological: HBV vaccine booster
Study Arms  ICMJE Active Comparator: booster
no antibody and boosted
Intervention: Biological: HBV vaccine booster
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
31
Original Enrollment  ICMJE
 (submitted: September 5, 2005)
50
Estimated Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children who received liver transplantation > 1 year ago

Exclusion Criteria:

  • Are now in an unstable condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147459
Other Study ID Numbers  ICMJE 931205
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Principal Investigator: Yen H Ni, MD, PhD NTUH
PRS Account National Taiwan University Hospital
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP