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| Sponsored by: |
National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00792610 |
Purpose
Several important controlled randomized clinical trials on hepatitis B immunoglobulin and vaccine in Taiwan demonstrated 80-90 percent protective effectiveness among infants from mothers who were either hepatitis B envelope antigen (HBeAg) or surface antigen (HBsAg) positive. A series of prevalence surveys on children born before and after the national vaccination program disclosed a steady decrease in seroprevalence of HBsAg in Taiwan with 78-87 percent effectiveness after the launch of the national vaccination program. Although hepatitis B vaccination has an excellent effectiveness against hepatitis B surface antigen, a gradual decline in anti-HBs titer among vaccinees by years after vaccination has been noted.
Whether seronegative cases for hepatitis B surface antigen, core antibody against hepatitis B, and surface antibody against hepatitis B need a booster of hepatitis B vaccine was still in debate. The aim of this study was to investigate the booster response and cellular immunity for the youth who had received complete doses of hepatitis B vaccines at their neonatal stage.
| Condition | Intervention |
|---|---|
|
Hepatitis B |
Biological: hepatitis B vaccine |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines |
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Hepatitis B booster: Experimental
They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
|
Biological: hepatitis B vaccine
Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.
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The main target population was the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B (anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers. Their neonatal hepatitis B vaccination records were linked through CDC databank Taiwan. Seronegative subjects for 3 viral markers signed informed consent and are included into this study. They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine. The adverse effect of the vaccine was also reported one week after each Engerix-B injection. The endpoint of measurement was anti-HBs (+) (%), and loss to follow up (%), respectively.
Eligibility| Ages Eligible for Study: | 18 Years to 23 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Chyi-Feng Jan, MD, PHD | 886-2-23123456 ext 66824 | jcf036@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 10051 | |
| Contact: Chyi-Feng Jan, Doctor 886-2-23123456 ext 66824 jcf036@ntu.edu.tw | |
| Principal Investigator: Chyi-Feng Jan, MD, PHD | |
| Sub-Investigator: Kuo-Chin Huang, MD, PHD | |
| Sub-Investigator: Li-Min Huang, MD, PHD | |
| Study Chair: | Chyi-Feng Jan, Doctor | National Taiwan University Hospital |
More Information
| Responsible Party: | NATIONAL TAIWAN UNIVERSITY HOSPITAL ( JAN CHYI-FENG/MD, PHD. ) |
| Study ID Numbers: | 200701049M, NSC96-2314-B-0020115 |
| Study First Received: | November 16, 2008 |
| Last Updated: | November 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00792610 |
| Health Authority: | Taiwan: Institutional Review Board |
|
youth hepatitis B vaccination booster immunity response |
|
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
|
Hepadnaviridae Infections |
