Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Hepatitis B Clinical Trial

Official title:

Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00147459
• Other study ID #: 931205
• 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

• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Transplantation

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