LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

Hepatitis B Clinical Trial

Official title:

Long-Term Follow-up Study at Years 16, 17, 18, 19 and 20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine Administered With or Without HBIG in Newborns of HBeAg+ Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240526
• Other study ID #: 100450
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: February 17, 2011
• Start date: October 2003
• Est. completion date: March 2010

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Description:

The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• Subjects who had received at least one dose of the study vaccine in the primary study

• Written informed consent obtained from each subject before each blood sampling visit

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™ -B
3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
• Hepatitis B immunoglobulin (HBIg)
1 intramuscular injections at birth (primary study)

Locations

Country	Name	City	State
Thailand	GSK Investigational Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration	Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).	Years 15, 16, 17, 18, 19 and 20	No
Primary	Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values	Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.	Years 15, 16, 17, 18, 19 and 20	No
Primary	Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection	Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).	Years 15, 16, 17, 18, 19 and 20	No
Primary	Number of Subjects With Different Hepatitis B Infection Statuses	Categories hepatitis B (HB) infection: Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples; False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg.; Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples.; Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg	Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)	No