Antibody Response and Immune Memory 15-18 Years After HBV Vaccination
Primary Purpose
Hepatitis B, Vaccine
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hepatitis B vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, vaccine
Eligibility Criteria
Inclusion Criteria: 15-18 years old healthy individuals Exclusion Criteria: Unhealthy individuals and those who refuse to participate
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00172328
First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00172328
Brief Title
Antibody Response and Immune Memory 15-18 Years After HBV Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
September 2004
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
Taiwan is an endemic region for hepatitis B. Before the implementation of a nationwide vaccination program in 1984, the hepatitis B virus (HBV) carrier rate in the general population was 15 to 20%.1-2 The major impact of hepatitis B (HB) infection is its long-term sequelae which may include chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma.3 Perinatal infection accounts for 40-50% of all hepatitis B infections and is responsible for the generation-to-generation transmission of HB virus.4 Hepatitis B vaccines, both plasma derived and recombinant, are highly immunogenic and efficacious.5-10 It has been reported that HB vaccine given soon after birth is able to protect infants from perinatal infection and HB infection became the first disease model to show that mother-to-neonate transmission can be interrupted by an effective vaccine.11 Taiwan started a national program of HB vaccination since 1984. This program resulted in a significant reduction of the HB carrier rate in children aged below 10 years from 9.8% before nationwide vaccination to 1.3% after the program.12 It also decreased the incidence of hepatocellular carcinoma in children aged 6 to 9 years from 0.52 to 0.13 per 100,000.13 However, the duration of protection provided by the HB vaccine and the proper timing of a booster dose remains unclear. Because the HB vaccine is a subunit protein vaccine, which contains only HBsAg, a limited duration of protection is anticipated. The results of several long-term follow-up studies of the protective efficacy of HB vaccination have been published. Soon after vaccination, protective levels of antibody (anti-HBs >10 mIU/mL) can be detected in the great majority (83-99%) of vaccinees.5-7 The proportion of vaccinees with protective anti-HBs levels decreases to 75-87% 5 years after vaccination and further drops to 50 to 70% 10-12 years after.10,11,14,15,19-21 Because of the progressive decline of anti-HBs and the associated increased likelihood of development of new HBV infections, some investigators advise the use of a booster vaccination.20,21 However, a preponderance of data indicates that the protective efficacy of the HB vaccine can last for at least 5 to 10 years and a booster before 5 years is not necessary.16-18,22,23 By demonstrating significant augmentation of cellular immunity and adequate induction of a protective level of antiHBs (>10 mIU/ml) in HBsAg and HBeAg-positive subjects 10 years after HB vaccination, we also proved that protection afforded by HB vaccination persisted for no less than 10 years in all vaccinees.R Nevertheless, the protective efficacy after the period of 10 years remains unknown. Knowledge of the duration of protection of HB vaccine and the optimal timing of booster vaccination remains crucial. In this study, we are going to examine the humoral and cellular immunity and monitored the antibody response following a booster dose of HB vaccine in a group of children whom had been vaccinated 14 years prior to this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Vaccine
Keywords
Hepatitis B, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
15-18 years old healthy individuals
Exclusion Criteria:
Unhealthy individuals and those who refuse to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Min Huang, MD,PhD
Phone
886-2-23123456
Ext
5139
Email
lmhunag@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Yi Lu, MD
Phone
886-2-23123456
Ext
3205
Email
chunyi@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Min Huang, MD,PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Min Huang, MD, PhD
Phone
886-2-23123456
Ext
5139
Email
lmhuang@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chun-Yi Lu, MD
Phone
886-2-23123456
Ext
3205
Email
Chunyi@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Li-Min Huang, MD,PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15565627
Citation
Lu CY, Chiang BL, Chi WK, Chang MH, Ni YH, Hsu HM, Twu SJ, Su IJ, Huang LM, Lee CY. Waning immunity to plasma-derived hepatitis B vaccine and the need for boosters 15 years after neonatal vaccination. Hepatology. 2004 Dec;40(6):1415-20. doi: 10.1002/hep.20490.
Results Reference
background
Learn more about this trial
Antibody Response and Immune Memory 15-18 Years After HBV Vaccination
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