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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00508833
• Collaborator: (none)
• Enrollment: 200
• Location: 1

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Mar 1, 2000

Outcome Measures

Primary Outcome Measures

1. Intensity of the CTL response at Week 6 []

Secondary Outcome Measures

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	GSK Clinical Trials Call Center	Gent		Belgium

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00508833
• Other Study ID Numbers: 287615/005
• First Posted: Jul 30, 2007
• Last Update Posted: Jul 30, 2007
• Last Verified: Jul 1, 2007

• Keywords provided by , ,: Adjuvants; HBsAg
• Additional relevant MeSH terms: Hepatitis B

Study Results

No Results Posted as of Jul 30, 2007