NCT00709800已完成1 期
A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vical
- 入组人数
- 56
- 试验地点
- 6
- 主要终点
- Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects
研究概览
简要总结
The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle 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 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
结局指标
主要结局
Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects
时间窗: 6 months
次要结局
- Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1(6 months)
研究者
研究点 (6)
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