Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: July 27, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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.

Condition Intervention Phase
Hepatitis B Disease
Biological: 287615 containing HBsAg with adjuvants
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 200
Study Start Date: March 2000

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00508833

GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided Identifier: NCT00508833     History of Changes
Other Study ID Numbers: 287615/005
Study First Received: July 27, 2007
Last Updated: July 27, 2007
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
HBsAg processed this record on November 27, 2015