NCT00032708已完成2 期
A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults
National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2004年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and interferon-y producing T cells
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
- Double
入排标准
- 接受健康志愿者
- 否
入选标准
- •For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox.
- •If female, not pregnant or lactating.
- •Promise to use an effective method of birth control for 7 months after vaccination.
- •Negative result on a test for HIV, AIDS, Hepatitis B and C.
- •Acceptable as blood donors.
- •For cohorts A, B, C, D (previously vaccinated): Aged 32 to 60 years; known history of smallpox vaccination with a typical vaccinia scar; no smallpox vaccination after
- •Healthy adults (aged 18-60).
排除标准
- •Eczema or history of eczema, or other chronic skin disorder.
- •Pregnancy or lactation.
- •History of immunodeficiency, liver disease, severe kidney impairment, malignancy, HIV, Hepatitis B, or Hepatitis C.
- •Household contact with persons who are under 12 months of age, pregnant or lactating, or have any of the specified diseases.
研究者
研究点 (2)
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