Clinical trial NCT00698906: Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y
Official title: Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 19-40 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B
HBV-MPL
Recombinant Hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

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:

* Age: between 19 and 40 years old.
* Good physical condition as established by clinical examination and history taking at the time of entry.
* Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
* Written informed consent obtained from the subjects

Exclusion Criteria:

* Positive titres at screening for anti-hepatitis antibodies.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous participation in any other clinical trial.
* Previous vaccination with a hepatitis B vaccine.
* Previous vaccination with an MPL containing vaccine.
* Administration of immunoglobulins in the past 3 months and during the whole study period
* Vaccination one month before and one month after each dose of the study vaccine

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Month 1, 2 and 6
measure: Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms
timeFrame: 31-day follow-up after vaccination
measure: Incidence of serious adverse events
timeFrame: During the study period
Other outcomes:
Locations:
city: Wien
country: Austria
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: