Clinical trial NCT00697749: Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Recombinant hepatitis B vaccine
Adjuvanted hepatitis B vaccine
Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 230
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility 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

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At month 7
Secondary outcomes:
measure: Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
timeFrame: During a 4 day follow-up period after each vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms
timeFrame: During a 30 day follow-up period after each vaccination
measure: Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
timeFrame: During the study period
measure: Anti-HBs antibody concentrations
timeFrame: Day 0, Month 1, Month 6 and Month 7
measure: Cell mediated immunity
timeFrame: At Months 0 and 7
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: