Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00147459|
Recruitment Status : Unknown
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 7, 2005
Last Update Posted : December 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Hepatitis B||Biological: HBV vaccine booster||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2006|
|Estimated Study Completion Date :||December 2012|
Active Comparator: booster
no antibody and boosted
|Biological: HBV vaccine booster|
- Persistence of anti-HBs in those primarily vaccinated and who underwent liver transplantation [ Time Frame: 1 year ]antibody(+)
- The necessity of a booster dose of HBV vaccine for those primarily vaccinated and who underwent liver transplantation [ Time Frame: 1 year ]if no antibody , booster
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147459
|Contact: Yen H Ni, MD, PhD||886-2-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Yen H Ni, MD, PhD 23123456 ext 5451|
|Principal Investigator:||Yen H Ni, MD, PhD||NTUH|