Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
研究概览
简要总结
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 45 years of age
- •Written informed consent
- •Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
- •Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry
排除标准
- •Any previous vaccination against Herpes simplex.
- •Any previous administration of MPL.
- •Pregnancy or lactation.
- •Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
- •Clinical signs of acute or febrile illness at the time of entry into the study.
- •Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
- •Any vaccination within one week of study vaccination.
- •Previous known hypersensitivity to vaccination or to any component of the vaccine.
- •Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
- •Recent history of alcoholism or drug abuse (within the past 6 months).
- •Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
结局指标
主要结局
To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
时间窗: After the second and third doses of each vaccine
To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
时间窗: After the second and third dose of each vaccine formulation
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
时间窗: During 3 days after each dose of each vaccine
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
时间窗: After 2 and 3 doses of vaccines
次要结局
未报告次要终点