NCT00699764已完成3 期
Safety of SmithKline Beecham Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL & Its Efficacy to Prevent Genital Herpes Disease in HSV Positive or Negative Consorts of Subjects With Genital Herpes Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,491
- 主要终点
- To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences
研究概览
简要总结
The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease.
详细描述
This study was monitored by a Data Safety Monitoring Board 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 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 at the time of first vaccination
- •Written informed consent
- •Females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control
- •The volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history
排除标准
- •Any previous history of or current clinical signs or symptoms of genital herpes disease.
- •Any previous vaccination against herpes simplex.
- •Any previous administration of MPL.
- •History of herpetic keratitis.
- •History of erythema multiforme.
- •Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose.
- •Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
- •HIV positive at the time of enrollment
- •Clinical signs of acute or febrile illness at the time of entry into the study.
- •Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
- •Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
- •Any vaccine administration less than one week before or after a study vaccination.
- •Previous known hypersensitivity to vaccination or to any component of the vaccine.
- •Simultaneous participation in any other clinical trial of an investigational compound.
- •Recent history of alcoholism or drug abuse
- •Recent clinical history or evidence of significant hepatic disease
- •Recent clinical history or evidence of renal dysfunction
- •Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
- •Inability or unwillingness to comply with the protocol or not expected to complete the study period
结局指标
主要结局
To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences
时间窗: During the 7 month vaccination period
To evaluate the protective efficacy of gD2t with adjuvant to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV seropositive at baseline
时间窗: Survival analysis beginning at Month 0
次要结局
- To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline(After 3 doses of vaccine (between months 7 and 19))
- To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative at baseline(Survival analysis beginning at Month 0)
- To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy male and female adults who are HSV seronegative or HSV-1 seropositive at baseline(Survival analysis beginning at Month 0)
- To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent symptoms of genital herpes disease in healthy female adults who are HSV seronegative at baseline(Survival analysis beginning at Month 0)
- To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline
- To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline.
研究者
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