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Completed

NCT Number: NCT00240539

Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)

This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

16 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Bangkok, 10330, Thailand

About this study

The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who had participated in the primary study.
  • Written informed consent obtained from the subject.

Treatment and study plan

blood sampling

Procedure

A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.

Primary outcomes

  1. Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies

    Time frame: At Years 16, 17, 18, 19 and 20 after primary vaccination

    Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.

  2. Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus

    Time frame: At Years 16, 17, 18,19 and 20 after primary vaccination

    Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).

  3. Number of Subjects With Chronic and With Clinical HBV Infection

    Time frame: From year 16 through to year 20

    • Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points.
    • Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Long-term Follow-Up Studies at Years 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2005
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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