NCT00082069已完成1 期
Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine
U.S. Army Medical Research and Development Command1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2004年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Systemic immune response
研究概览
简要总结
The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits.
详细描述
This is an open-labeled dose escalating trial in which a total of 32 subjects (minimum of 24 allowable) will receive one of four intranasal Invaplex 50 vaccine doses according to the following chart:
Test articles/dose
Group / N* / Invaplex 50
A / 8 / 10 micrograms
B / 8 / 50 micrograms
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be in very good health.
排除标准
- •Smoker, or have stopped smoking less than one year ago
- •History of chronic illnesses, such as: asthma, chronic sinusitis, or chronic seasonal allergies (such as hay fever)
- •Received a vaccination for Shigella or exposure to Shigella bacteria in a research study or through work in a laboratory
- •Positive for HIV, hepatitis B, and hepatitis C by blood test
- •Using anti-diarrheal, anti-constipation, or antacid medications on a regular basis
结局指标
主要结局
Systemic immune response
Safety
Mucosal immune response
次要结局
未报告次要终点
研究者
研究点 (1)
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