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)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240539

100449

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 16 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

HBsAg(+) & HBeAg(-) 4-dose Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

HBsAg(+) & HBeAg(+) 4-dose Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

HBsAg(+) & HBeAg(+) 5-dose Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

HBsAg(-) & HBeAg(-) 4-dose Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling