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Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697749
First received: June 11, 2008
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype

Condition Intervention Phase
Hepatitis B
Biological: HBV-MPL vaccine 208129
Biological: Engerix™-B
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: Phase III Study to Compare Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Adminstered Intramuscularly, According to a 0, 6 Month Schedule, to Engerix™-B 20 mcg Administered According to a 0,1,6 Month Schedule in Healthy Volunteers Positive for the HLA-DQ2 Genotype

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: At month 7 ]

Secondary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4 day follow-up period after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During a 30 day follow-up period after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) [ Time Frame: During the study period ]
  • Anti-HBs antibody concentrations [ Time Frame: Day 0, Month 1, Month 6 and Month 7 ]
  • Cell mediated immunity [ Time Frame: At Months 0 and 7 ]

Enrollment: 230
Study Start Date: April 1999
Study Completion Date: January 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Active Comparator: Group B Biological: Engerix™-B
3-dose intramuscular injection

Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female ≥ 15 years of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the subject/ from the parents or guardians of the subject.
  • Known to be seronegative for anti-HBs-antibodies, anti-HBc-antibodies and/or HBsAg.
  • Positive for the HLA-DQ2 genotype as determined in the previous sero-HBV-069 prevalence study.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
  • Previous vaccination against hepatitis B.
  • History of non-response to previous hepatitis B vaccination.
  • Known exposure to hepatitis B within 6 weeks.
  • History of hepatitis B infection.
  • Confirmed human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrollment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
  • Pregnant or lactating female
  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: NCT00697749

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208129/034
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208129/034
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208129/034
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 208129/034
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208129/034
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 208129/034
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00697749     History of Changes
Other Study ID Numbers: 208129/034 
Study First Received: June 11, 2008
Last Updated: September 15, 2016
Health Authority: Belgium: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Recombinant hepatitis B vaccine
Adjuvanted hepatitis B vaccine
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016