A Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 360
- 主要终点
- Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine
研究概览
简要总结
This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9 vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good general health
- •Subject tests negative for Hepatitis B, Hepatitis C, and HIV
- •Subjects of reproductive potential agree to use an accepted method of birth control through the entire study
排除标准
- •Subject has a recent history of fever at time of vaccination
- •Subject has received immune globulin or blood product 3 months prior to injection
- •Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
- •Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
- •Subject has a chronic medical condition that is considered progressive
- •Subject has history of malignancy
- •Subject weighs less than 105 lb.
- •Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
- •Subject has contraindication to intramuscular injection
- •Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
- •Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
研究组 & 干预措施
1
V520 (1x10^9 vp/d)
干预措施: Comparator: V520 (1x10^9 vp/d) (Biological)
2
V520 (1x10^10 vp/d)
干预措施: Comparator: V520 (1x10^10 vp/d) (Biological)
3
Placebo to V520
干预措施: Comparator: Placebo (Biological)
1
V520 (1x10^9 vp/d)
干预措施: V520 (Biological)
结局指标
主要结局
Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine
时间窗: 4 weeks after third vaccination
次要结局
- breadth of immune response measured by several assays(4 weeks after third vaccination)