Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
This study has been completed.
Information provided by:
First received: June 11, 2008
Last updated: June 13, 2008
Last verified: June 2008
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
Biological: HBV-MPL vaccine 208129
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||Study to Compare the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted HBV Vaccine (0, 6 Month Schedule) to Engerix™-B (0, 1, 6 Month Schedule) in Healthy (≥ 15 Years) Volunteers Positive for the HLA-DQ2 Genotype
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 ]
| Study Start Date:
| Primary Completion Date:
||January 2000 (Final data collection date for primary outcome measure)
Experimental: Group A
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Active Comparator: Group B
3-dose intramuscular injection
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
|Ages Eligible for Study:
||15 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697749
|GSK Clinical Trials Call Center
|Wilrijk, Belgium |
No publications provided
||Isabelle Harpigny, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 11, 2008
||June 13, 2008
||Belgium: Institutional Review Board
Keywords provided by GlaxoSmithKline:
Adjuvanted hepatitis B vaccine
Recombinant hepatitis B vaccine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections