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Home > Protocol Summaries: Compounds > SB287615 > Protocol Summary for 287615/005

Protocol Summary for 287615/005

Protocol Summary
Protocol Id: 287615/005
Secondary Ids:
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
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: Interventional
Oversight Authority:
  • Belgium: Institutional Review Board
Collaborators:
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:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: March 2000
Study Completion Date:
Study Completion Date Type: None
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Prevention
Allocation: Randomized
Masking: Double Blind
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Intensity of the CTL response at Week 6
Secondary Outcomes:
  • 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
Conditions:
  • Hepatitis B Vaccine
Keywords:
  • Adjuvants
  • HBsAg
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 40 Years
Enrollment: 200
Enrollment Type: Anticipated
Healthy Volunteers?: Yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.