Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y
Phase 2
Completed
- Conditions
- Hepatitis B
- Interventions
- Biological: HBV-MPL vaccineBiological: Engerix™-B
- Registration Number
- NCT00698555
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will evaluate the immunogenicity and safety of different formulations of the candidate 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
Inclusion Criteria
- Age: between 18 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 6 months and during the whole study period
- Vaccination one month before and one month after each dose of the study vaccine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A HBV-MPL vaccine - Group B HBV-MPL vaccine - Group C HBV-MPL vaccine - Group D HBV-MPL vaccine - Group E HBV-MPL vaccine - Group F Engerix™-B -
- Primary Outcome Measures
Name Time Method Anti-HBs antibody concentrations Month 7
- Secondary Outcome Measures
Name Time Method Anti-HBs antibody concentrations Month 1, 2, 6 and 12 Cell mediated immunity Month 1, 2, 6, 7 and 12 Occurrence and intensity and relationship to vaccination of solicited local and general symptoms 4-day follow-up after vaccination Occurrence and intensity and relationship to vaccination of unsolicited symptoms 31-day follow-up after vaccination Incidence of SAE Throughout the study period
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇧🇪Gent, Belgium