NCT01698060已完成1 期
An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of ND1.1 by Delivery Directly to the Ileum Using the InteliSite® Companion Capsule in Healthy Adult Males
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of ND1.1 oral vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able and willing to complete informed consent
- •Healthy, as established by medical history, physical exam, and laboratory assessments
- •Has normal bowel movements
- •Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge
排除标准
- •Ability to donate up to 550 ml of blood over several months
- •Exposure to any investigational drug or vaccine 8 weeks prior to study
- •Has traveled to Asia within 8 weeks of enrollment
- •Abnormal ECG findings
- •History of irritable bowl or any other inflammatory gastrointestinal disorder
- •Any individual with increased risk for bowl obstruction
- •Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSv in the past 12 months
- •History of substance abuse
- •Subject unwilling to use an approved method of contraception during study and for 2 months after study
- •Positive for HCV, HIV, or HBV
- •Presence of an implantable device that is sensitive to radio frequencies (e.g. pacemakers)
- •History of an autoimmune disorder, or an immunosuppressive disorder
- •Stool sample with occult blood at baseline
- •Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator, is a contraindication to the compliance of the protocol or informed consent
结局指标
主要结局
Safety
时间窗: 1 year
Frequency and magnitude of adverse events
次要结局
- Immunogenicity(1 year)
研究者
研究点 (1)
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