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)
- Conditions
- Hepatitis B
- Interventions
- Procedure: Blood sampling
- Registration Number
- NCT00240539
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Subjects who had participated in the primary study.
- Written informed consent obtained from the subject.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HBsAg(+) & HBeAg(-) 4-dose Group Blood sampling Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study. HBsAg(+) & HBeAg(+) 4-dose Group Blood sampling Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 4 doses of Engerix™ in the primary study. HBsAg(+) & HBeAg(+) 5-dose Group Blood sampling Newborns of anti-hepatitis B surface antigen positive \[HBsAg(+)\] and hepatitis B envelope antigen positive \[HBeAg(+)\] mothers, who received 5 doses of Engerix™ in the primary study. HBsAg(-) & HBeAg(-) 4-dose Group Blood sampling Newborns of anti-hepatitis B surface antigen negative \[HBsAg(-)\] and hepatitis B envelope antigen negative \[HBeAg(-)\] mothers, who received 4 doses of Engerix™ in the primary study.
- Primary Outcome Measures
Name Time Method Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies At Years 16, 17, 18, 19 and 20 after primary vaccination Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus 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).
Number of Subjects With Chronic and With Clinical HBV Infection 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇹🇭Bangkok, Thailand