NCT00694213已完成1 期
A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With the Biojector® 2000 Needle-Free System
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vical
- 入组人数
- 47
- 试验地点
- 6
- 主要终点
- Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects.
研究概览
简要总结
The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.
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
- Triple (Participant, Care Provider, 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
- •18 to 45 years of age
- •Able to provide informed consent and be followed for 6 months
排除标准
- •No immunomodulatory therapy within the past 6 months
- •No evidence of immunodeficiency or pregnancy
- •No laboratory or evidence of clinically significant medical disease
- •No history of previous pDNA immunization
- •No influenza immunization within the past 30 days
- •No blood donations within 30 days of screening visit
- •No history of bleeding disorder
- •No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines
研究组 & 干预措施
2
Experimental
干预措施: VCL-IPM1 (Biological)
1
Experimental
干预措施: VCL-IPM1 (Biological)
3
Experimental
干预措施: VCL-IPT1 (Biological)
4
Placebo Comparator
干预措施: PBS (Biological)
结局指标
主要结局
Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects.
时间窗: 6 months
次要结局
- Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000(6 months)
研究者
研究点 (6)
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