NCT00532974Unknown1 期
A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)
Epimmune4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms.
研究概览
简要总结
The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 Infection
- •CD4 Tcell count >350
- •HIV-1 RNA levels to <400 copies
- •Negative HbsAg and anti-HCV antibody
排除标准
- •Recent receipt of experimental HIV-1 vaccines
- •Recent use of immunomodulatory agents
- •Hypersensitivity or serious reactions to study vaccine components
- •Active opportunistic infections
结局指标
主要结局
Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms.
时间窗: six months
次要结局
未报告次要终点
研究者
研究点 (4)
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