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临床试验/NCT00147459
NCT00147459Unknown不适用

Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2005年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
31
试验地点
1
主要终点
Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Children who received liver transplantation > 1 year ago

排除标准

  • Are now in an unstable condition

研究组 & 干预措施

booster

Active Comparator

no antibody and boosted

干预措施: HBV vaccine booster (Biological)

结局指标

主要结局

Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation

时间窗: 1 year

antibody(+)

次要结局

  • The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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