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

GlaxoSmithKline2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2000年3月1日最近更新: 2007年7月30日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 200
试验地点: 2
主要终点: Intensity of the CTL response at Week 6

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy volunteers between 18 and 40 years of age
•Written informed consent obtained from subject
•Female of non-childbearing potential

排除标准

•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

结局指标

主要结局

Intensity of the CTL response at Week 6

次要结局

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

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

研究点 (2)

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