Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
Phase 1
Completed
- Conditions
- Hepatitis B
- Interventions
- Biological: HBV-MPL vaccine 208129Biological: Engerix™-B
- Registration Number
- NCT00699231
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B
- 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
- 30
Inclusion Criteria
- Dialysis patients
- A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- Age: from 18 years onwards
- Seronegative for anti- hepatitis antibodies
Exclusion Criteria
- History of persistent hepatic, cardiac or respiratory disease
- Any acute disease at the moment of entry into the study
- Chronic alcohol consumption
- Hepatomegaly, right upper quadrant pain or tenderness
- Any treatment with coticosteroids or immunomodulating drugs
- Known hypersensitivity to any component of the vaccine
- Simultaneous participation in any other clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C2 HBV-MPL vaccine 208129 Volunteers participating in the hospital's vaccination program Group D1 Engerix™-B Unvaccinated haemodialysis patients Group B1 Engerix™-B Vaccine-responders requiring a booster dose Group A1 Engerix™-B Non-responders to vaccination after at least 7 previous injections Group D2 HBV-MPL vaccine 208129 Unvaccinated haemodialysis patients Group A2 HBV-MPL vaccine 208129 Non-responders to vaccination after at least 7 previous injections Group B2 HBV-MPL vaccine 208129 Vaccine-responders requiring a booster dose Group C1 Engerix™-B Volunteers participating in the hospital's vaccination program
- Primary Outcome Measures
Name Time Method Anti-HBs antibody concentrations Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation Occurrence and intensity of solicited local and general symptoms 4-day follow-up period after each vaccination Occurrence of unsolicited adverse events During the course of the study Occurrence of serious adverse events During the course of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇧🇪Brussels, Belgium