NCT00850616已完成1 期
A Phase I Dose Ranging Study of the Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Immune response to MRKAd5+6 trigene vaccine
研究概览
简要总结
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine
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 has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection
- •Subject agrees to use an acceptable method of birth control through week 52 of the study
排除标准
- •Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine
- •Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
- •Subject has known or suspected impaired immune function
- •Subject has participated in any other HIV vaccine trial
- •Female subject is pregnant or breastfeeding
研究组 & 干预措施
8
Placebo Comparator
Placebo
干预措施: Comparator: Placebo to V526 (Biological)
6
Experimental
MRKAd5+6 Trigene 1x10^9 Ad vg
干预措施: V526 (Biological)
4
Experimental
MRKAd5 Trigene 0.5x10^10 Ad5 vg
干预措施: V526 (Biological)
7
Experimental
MRKAd5+6 Trigene 1x10^10 Ad vg
干预措施: V526 (Biological)
5
Experimental
MRKAd5 Trivalent 1.5x10^10 Ad5 vg
干预措施: V526 (Biological)
3
Experimental
MRKAd6 Trigene 0.5x10^11 Ad6 vg
干预措施: V526 (Biological)
2
Experimental
MRKAd6 Trigene 0.5x10^10 Ad6 vg
干预措施: V526 (Biological)
1
Experimental
MRKAd6 Trigene 0.5x10^9 Ad6 vg
干预措施: V526 (Biological)
结局指标
主要结局
Immune response to MRKAd5+6 trigene vaccine
时间窗: 30 week
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
时间窗: Week 30
次要结局
- Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6(Week 30)
研究者
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