Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Phase 1
Completed
- Conditions
- Hepatitis B Disease
- Registration Number
- NCT00508833
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Healthy volunteers between 18 and 40 years of age
- Written informed consent obtained from subject
- Female of non-childbearing potential
Exclusion Criteria
- Any hepatitis B vaccination.
- Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
- Pregnancy or lactating female
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Intensity of the CTL response at Week 6
- Secondary Outcome Measures
Name Time Method Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇧🇪Gent, Belgium