Skip to content

Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00147459
Enrollment
31
Registered
2005-09-07
Start date
2005-09-30
Completion date
2012-12-31
Last updated
2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Liver Transplantation

Keywords

hepatitis B virus, vaccine, booster, liver transplantation

Brief 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.

Detailed 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.

Interventions

BIOLOGICALHBV vaccine booster

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Children who received liver transplantation \> 1 year ago

Exclusion criteria

* Are now in an unstable condition

Design outcomes

Primary

MeasureTime frameDescription
Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation1 yearantibody(+)

Secondary

MeasureTime frameDescription
The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation1 yearif no antibody , booster

Countries

Taiwan

Contacts

Primary ContactYen H Ni, MD, PhD
yhni@ha.mc.ntu.edu.tw886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026