Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147459
Status:
UNKNOWN
Last Update Posted:
2012-12-06
First Post:
2005-09-05
Brief Title:
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AimBackground 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 authors 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 IUL 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
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 IUL 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 IUL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None