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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00508833
First received: July 27, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508833

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

No publications provided

ClinicalTrials.gov 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:
Adjuvants
HBsAg

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013