Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289770
First received: February 9, 2006
Last updated: November 10, 2011
Last verified: October 2011
  Purpose

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives & outcome measures of the extension phase at Year 11-15.


Condition Intervention Phase
Hepatitis B
Hepatitis A
Biological: Twinrix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value [ Time Frame: Years 11, 12, 13, 14 and 15 ] [ Designated as safety issue: No ]
    Cut-off value was defined as 15 milli-international units per milliliter (mIU/mL). This was considered as seropositivity.

  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values [ Time Frame: Years 11, 12, 13, 14 and 15 ] [ Designated as safety issue: No ]
    Cut-off values were defined 3.3 mIU/mL, which was also considered as seropositivity, and 10 mIU/mL.

  • Anti-HAV and Anti-HBs Antibody Concentrations [ Time Frame: Years 11, 12, 13, 14 and 15 ] [ Designated as safety issue: No ]

    Concentrations are expressed as geometric mean concentrations (GMCs) in mIU/mL.

    The laboratory assay was changed at Year 13 for anti-HBs GMCs.


  • Anti-HBs Antibody Concentrations [ Time Frame: at Year 11, pre-additional vaccine, after additional dose of Engerix ] [ Designated as safety issue: No ]

    Subjects who lost seroprotective concentrations for anti-HBs (< 10 mIU/mL) at any of the LT follow-up timepoints received an additional dose of Engerix after year 15.

    Two subjects were eligible for this after Year 11.

    3.29 in the table means a concentration of < 3.3 mIU/mL.

    As the concentration was calculated per subject no mean concentration was calculated and also no measure of dispersion.


  • Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response [ Time Frame: 30 days post additional dose of Engerix ] [ Designated as safety issue: No ]

    Anamnestic response was assessed in subjects receiving an additional vaccine dose of Engerix. Two subjects were found eligible at Year 11 for this additional vaccine dose.

    Anamnestic response was defined as:

    • post-additional vaccination anti-HBs concentration >= 10 mIU/mL in subject seronegative before additional dose.
    • 4-fold increase post-additional dose compared to pre-additional vaccine time point.

  • Number of Subjects With Solicited Local and General Symptoms Assessed [ Time Frame: During the 4-day follow-up period after additional vaccination with Engerix ] [ Designated as safety issue: No ]
    Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, fever, gastrointestinal, headache.

  • Number of Subjects With Unsolicited Symptoms [ Time Frame: During the 30-day follow-up period after additional Engerix vaccination ] [ Designated as safety issue: No ]
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the 30-day follow-up period after additional Engerix vaccination ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject

  • Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy [ Time Frame: up to Year 11, 12, 13, 14, 15 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 50
Study Start Date: November 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Was vaccinated with Lot A in the primary study.
Biological: Twinrix™
Intramuscular injection, 3 doses
Experimental: Group B
Was vaccinated with Lot B in the primary study.
Biological: Twinrix™
Intramuscular injection, 3 doses
Experimental: Group C
Was vaccinated with Lot C in the primary study.
Biological: Twinrix™
Intramuscular injection, 3 doses

Detailed Description:

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule with 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited in the course of this extension study. If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
  • Written informed consent will have been obtained from each subject. before the blood sampling visit of each year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289770

Locations
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00289770     History of Changes
Other Study ID Numbers: 100551 (EXT Y11), 100552 (EXT Y12), 100553 (EXT Y13), 100554 (EXT Y14), 100555 (EXT Y15)
Study First Received: February 9, 2006
Results First Received: November 30, 2010
Last Updated: November 10, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
TWINRIX™ ADULT
Hepatitis A
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 16, 2014