A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 210
- 主要终点
- Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
研究概览
简要总结
This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.
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
- •Demonstrates good general health
- •Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
- •Low risk of acquiring HIV infection
- •ALT lab value within normal range
排除标准
- •Previously received an investigational HIV vaccine
- •Has a known or suspected impairment of immunologic function
- •Has a clinically significant chronic medical condition that is considered progressive
- •Has a major psychiatric illness
- •Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
- •Weighs less than 105 lbs.
- •Has a recent (within two years) history of chronic alcohol abuse
- •Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
- •Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
- •Male subject is planning to impregnate or provide sperm donation during the study
研究组 & 干预措施
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
干预措施: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520) (Biological)
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
干预措施: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520) (Biological)
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
干预措施: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520) (Biological)
结局指标
主要结局
Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
时间窗: 30 weeks
次要结局
未报告次要终点