NCT00075049已完成1 期
Dbl-Blind, Rand Phase 1/2a Human Challenge Study, to Eval Safety, Reactogenicity, Immunogenicity and Preliminary Efficacy After Sporozoite Challenge/Rechallenge of Vaccines Containing RTS,S
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2003年12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
- 104
- 试验地点
- 2
- 主要终点
- To assess the safety and reactogenicity of the candidate vaccine
研究概览
简要总结
This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
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
- •Be in good general health
- •Be able to participate for 4-15 months
排除标准
- •Pregnant or planning pregnancy
- •History of malaria or exposure to malaria in past 12 months
- •Received an investigational malaria vaccine
- •Past history of allergic reaction to previous immunization
- •Positive blood tests for HIV and specific types of hepatitis
结局指标
主要结局
To assess the safety and reactogenicity of the candidate vaccine
次要结局
- To assess the humoral immune response to the candidate vaccine
- To assess the efficacy of the candidate vaccine
研究者
研究点 (2)
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