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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00147459
Other study ID # 931205
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2005
Last updated December 4, 2012
Start date September 2005
Est. completion date December 2012

Study information

Verified date December 2012
Source National Taiwan University Hospital
Contact Yen H Ni, MD, PhD
Phone 886-2-23123456
Email yhni@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 31
Est. completion date December 2012
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Children who received liver transplantation > 1 year ago

Exclusion Criteria:

- Are now in an unstable condition

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Biological:
HBV vaccine booster


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation antibody(+) 1 year No
Secondary The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation if no antibody , booster 1 year No
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