Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
研究概览
简要总结
The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Written informed consent
- •Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
- •Good clinical condition as evidenced by history taking and physical examination
排除标准
- •History of persistent hepatic, renal, cardiac or respiratory diseases.
- •Clinical signs of acute illness at the time of entry into the study.
- •Seropositive for antibodies against the human immunodeficiency virus (HIV).
- •Pregnancy, lactation.
- •Treatment with corticosteroids or immunomodulating drugs.
- •Simultaneous participation in another clinical trial.
- •Any previous history of allergy.
- •Any concomitant vaccination or administration of immunoglobulin during the study period.
- •Any abnormal laboratory value among the tests performed at screening
研究组 & 干预措施
Group A
HSV seropositive subjects
干预措施: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant (Biological)
Group B
HSV seronegative subjects
干预措施: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant (Biological)
Group C
HSV seropositive subjects
干预措施: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant (Biological)
Group D
HSV seronegative subjects
干预措施: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant (Biological)
结局指标
主要结局
To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
时间窗: Days 0, 30, 60, 180 and 365 after vaccination
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
时间窗: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
次要结局
未报告次要终点