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

Hepatitis B Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508833
• Other study ID #: 287615/005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2007
• Last updated: July 27, 2007
• Start date: March 2000

Study information

• Verified date: July 2007
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hepatitis B Disease

Intervention

Biological:
• 287615 containing HBsAg with adjuvants

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of the CTL response at Week 6
Secondary	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