An interventional study of HBV vaccine booster in Liver Transplantation and Hepatitis B, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2012-12-06.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 31 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
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Exclusion Criteria:
no antibody and boosted
Biological: HBV vaccine booster
Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation
antibody(+)
Time frame: 1 year
The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation
if no antibody , booster
Time frame: 1 year
This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital