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)

NCT00240539 | Completed Phase 4 Results

• 1 other identifier: 100449
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Keywords

Hepatitis B

Outcome Measures

Primary Outcomes (3)

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

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

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

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

  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).

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

• Number of Subjects With Chronic and With Clinical HBV Infection

  * 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.

  From year 16 through to year 20

Study Arms (4)

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

EXPERIMENTAL

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.

Procedure: Blood sampling

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

EXPERIMENTAL

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.

Procedure: Blood sampling

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

EXPERIMENTAL

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.

Procedure: Blood sampling

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

EXPERIMENTAL

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.

Procedure: Blood sampling

Interventions

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.

HBsAg(+) & HBeAg(+) 4-dose Group; HBsAg(+) & HBeAg(+) 5-dose Group; HBsAg(+) & HBeAg(-) 4-dose Group; HBsAg(-) & HBeAg(-) 4-dose Group

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bangkok, 10330, Thailand

Location

Related Publications (3)

• Poovorawan Y, Chongsrisawat V, Theamboonlers A, Srinivasa K, Hutagalung Y, Bock HL, Hoet B. Long-term benefit of hepatitis B vaccination among children in Thailand with transient hepatitis B virus infection who were born to hepatitis B surface antigen-positive mothers. J Infect Dis. 2009 Jul 1;200(1):33-8. doi: 10.1086/599331.

  PMID: 19473096 BACKGROUND

• Poovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011.

  BACKGROUND

• Poovorawan Y, Chongsrisawat V, Theamboonlers A, Crasta PD, Messier M, Hardt K. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand. Hum Vaccin Immunother. 2013 Aug;9(8):1679-84. doi: 10.4161/hv.24844. Epub 2013 May 31.

  PMID: 23732904 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

No safety data were collected during this long-term follow-up study.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 18, 2005
• Study Start: October 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 8, 2016
• Results First Posted: November 17, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)