Antibody Response and Immune Memory 15-18 Years After HBV Vaccination

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172328
First received: September 12, 2005
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

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.


Condition Intervention
Hepatitis B
Vaccine
Biological: Hepatitis B vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 15-18 years old healthy individuals

Exclusion Criteria:

  • Unhealthy individuals and those who refuse to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172328

Contacts
Contact: Li-Min Huang, MD,PhD 886-2-23123456 ext 5139 lmhunag@ha.mc.ntu.edu.tw
Contact: Chun-Yi Lu, MD 886-2-23123456 ext 3205 chunyi@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Li-Min Huang, MD, PhD    886-2-23123456 ext 5139    lmhuang@ha.mc.ntu.edu.tw   
Contact: Chun-Yi Lu, MD    886-2-23123456 ext 3205    Chunyi@ha.mc.ntu.edu.tw   
Principal Investigator: Li-Min Huang, MD,PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Li-Min Huang, MD,PhD National Taiwan University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00172328     History of Changes
Other Study ID Numbers: 930306
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Hepatitis B
vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 20, 2014