Clinical trial NCT00697853: Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
Official title: Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B
Adjuvanted hepatitis B vaccine
Recombinant hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine

Detailed description: This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.

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 between 15 and 50 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 and/or from the parents or guardians of the subject.
* 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 vaccination 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.
* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
* 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 significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including 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.
* Oral temperature of ≥37.5°C (99.5°F).
* 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.
* History of chronic alcohol consumption and/or intravenous drug abuse

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At month 7
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At months 1, 2 and 6
measure: Occurrence and intensity of solicited local and general symptoms
timeFrame: 4-day follow-up period after each vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms
timeFrame: 30-day follow-up period after each vaccination
measure: Occurrence, intensity and relationship to vaccination of SAEs
timeFrame: Throughout the entire study
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: GSK Clinical Trial Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: