LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Comparative Study of the Immunogenicity and Protective Efficacy of GlaxoSmithKline Biologicals' Rec-DNA Hepatitis B Vaccine With or Without Hepatitis B Immunoglobulins (HBIg) in Newborns of HBeAg+ Mothers.
1 other identifier
interventional
79
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 13, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 15, 2010
CompletedDecember 7, 2016
October 1, 2016
6.4 years
October 13, 2005
June 14, 2010
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL.
At Years 15, 16, 17, 18, 19 and 20
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL.
At Years 19 and 20
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
At Years 15, 16, 17, 18, 19 and 20
Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL. Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations.
At Years 19 and 20
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).
At Years 15, 16, 17, 18, 19 and 20
Number of Subjects With Different Hepatitis B Infection Statuses
Categories hepatitis B (HB) infection: 1. Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples 2. False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg. 3. Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples. 4. 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)
Study Arms (4)
Engerix 4D + HBIg Group
EXPERIMENTALSubjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
Engerix 3D + HBIg Group
EXPERIMENTALSubjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
Engerix 4D
EXPERIMENTALSubjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.
Engerix 3D Group
EXPERIMENTALSubjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6.
Interventions
3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
1 intramuscular injections at birth (primary study)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Bangkok, 10330, Thailand
Related Publications (1)
Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1.
PMID: 22777097DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Additional tables have been generated following partial retesting and reanalysis of the results at Years 19 and 20.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
March 1, 2010
Study Completion
March 1, 2010
Last Updated
December 7, 2016
Results First Posted
July 15, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.