Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00984139
First received: September 24, 2009
Last updated: July 3, 2014
Last verified: March 2012
  Purpose

This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B Kinder
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine (Engerix™-B)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value [ Time Frame: One month after the challenge dose (Month 1) ] [ Designated as safety issue: No ]
    The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).

  • Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value. [ Time Frame: One month after the challenge dose (Month 1) ] [ Designated as safety issue: No ]
    The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).


Secondary Outcome Measures:
  • Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values [ Time Frame: Before (Day 0) and one month (Month 1) after the challenge dose ] [ Designated as safety issue: No ]

    The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.

    Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.


  • Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values [ Time Frame: Before (Day 0) and one month (Month 1) after the challenge dose ] [ Designated as safety issue: No ]
    The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.

  • Number of Subjects With Solicited Local and General Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination ] [ Designated as safety issue: No ]

    Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.

    Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius.


  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1) ] [ 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 Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period following the challenge dose 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 Anamnestic Response to the Challenge Dose as Measured by ELISA. [ Time Frame: One month after the challenge dose (Month 1) ] [ Designated as safety issue: No ]
    Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.

  • Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA. [ Time Frame: One month after the challenge dose (Month 1) ] [ Designated as safety issue: No ]
    Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.


Enrollment: 306
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Engerix-B Group
Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Biological: Engerix™-B Kinder
Intramuscular, one dose.
Other Names:
  • HBV vaccine
  • Engerix™-B

  Eligibility

Ages Eligible for Study:   12 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
  • A male or female of 12 to 13 years of age at the time of enrolment.
  • With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
  • Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
  • Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix-B vaccine.
  • History of hepatitis B disease.
  • Hepatitis B vaccination at birth.
  • Adolescents living in institutional care.
  • Planned administration /administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.
  • Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge..
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
  • Acute disease and/or fever at the time of enrolment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984139

Locations
Germany
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68163
GSK Investigational Site
Pforzheim, Baden-Wuerttemberg, Germany, 75172
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Cham, Bayern, Germany, 93413
GSK Investigational Site
Gilching, Bayern, Germany, 82205
GSK Investigational Site
Kempten, Bayern, Germany, 87435
GSK Investigational Site
Kirchheim, Bayern, Germany, 85551
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Muenchen, Bayern, Germany, 81375
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Braunatal, Hessen, Germany, 34225
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47137
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48163
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 10967
GSK Investigational Site
Berlin, Germany, 13055
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00984139     History of Changes
Other Study ID Numbers: 112682
Study First Received: September 24, 2009
Results First Received: February 3, 2011
Last Updated: July 3, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
persistence
HBV
Long-term
Engerix™-B Kinder
Hepatitis B
adolescent

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 September 18, 2014