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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis B Disease

Treatments

Biological: 287615 containing HBsAg with adjuvants

Study type

Interventional

Funder types

Industry

Identifiers

NCT00508833

287615/005

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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