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Hepatitis BNCT00172328

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

A study testing Hepatitis B vaccine in people with Hepatitis B and Vaccine, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Vaccine
What is being tested?
Hepatitis B vaccine
Type of treatment
Vaccines
How many people
Not given
Where
1 siteTaiwan
Study dates
Start not givento not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 15-18 years old healthy individuals

Who cannot join

  • Unhealthy individuals and those who refuse to participate

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Li-Min Huang, MD, PhD, 886-2-23123456 ext. 5139, lmhuang@ha.mc.ntu.edu.tw

    Chun-Yi Lu, MD, 886-2-23123456 ext. 3205, Chunyi@ha.mc.ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

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.

Conditions
Hepatitis B, Vaccine
Being tested
Hepatitis B vaccine
Keywords
Hepatitis B, vaccine
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatitis B vaccineBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00172328
Sponsor's protocol ID
930306
Status last verified
Sep 2004
First submitted
12 Sep 2005
Last updated
15 Sep 2005
Results posted
No

Publications

  • 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.

    PubMed 15565627

Questions about this trial

What is this clinical trial studying?

A study testing Hepatitis B vaccine in people with Hepatitis B and Vaccine, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li-Min Huang, MD,PhD (886-2-23123456 ext. 5139, lmhunag@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00172328, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2005.

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