Back to resultsSafety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Primary Purpose
Hepatitis B Disease
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
287615 containing HBsAg with adjuvants
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B Disease focused on measuring Adjuvants, HBsAg
Eligibility Criteria
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
Sites / Locations
- GSK Clinical Trials Call Center
Outcomes
Primary Outcome Measures
Intensity of the CTL response at Week 6
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00508833
Brief Title
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Official Title
Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Disease
Keywords
Adjuvants, HBsAg
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
287615 containing HBsAg with adjuvants
Primary Outcome Measure Information:
Title
Intensity of the CTL response at Week 6
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Gent
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
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