An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
研究概览
简要总结
The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.
详细描述
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Between 18 and 40 years of age
- •Seropositive for antibodies against HSV
- •Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
- •Good physical condition as established by physical examination and history taking at the time of entry
排除标准
- •Any abnormal laboratory value among the tests performed at screening.
- •History of persistent hepatic, renal, cardiac or respiratory diseases
- •Clinical signs of acute illness at the time of entry into the study.
- •Previous history of asthma or hypersensitivity to drugs.
- •Seropositive for antibodies against the human immunodeficiency virus
- •Pregnancy and lactation.
- •Treatment with corticosteroids or immunomodulating drugs.
- •Simultaneous participation in another clinical trial.
- •Administration of any other vaccine or immunoglobulins during the study period
结局指标
主要结局
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
时间窗: Throughout the study
Measurement of haematology/biochemical parameters on blood samples
时间窗: Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
时间窗: On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
时间窗: From day 0 to day 45 following vaccination
次要结局
未报告次要终点