Re-exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- A difference in occurrence of signs or symptoms between EHMI-8 and control volunteers
研究概览
简要总结
In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P. falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in this study strongly supports the development of whole parasite vaccines and is therefore an important finding to malaria vaccine development. In this study (EHMI8B) the investigators would like to explore the longevity of the protective immune response and simultaneously further characterise immune mechanisms responsible for protection by re-exposing EHMI-8 volunteers to infected mosquito bites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
A difference in occurrence of signs or symptoms between EHMI-8 and control volunteers
时间窗: 21 days
A significant difference in time of thick smear positivity between EHMI-8 and control volunteers
时间窗: 21 days
A significant difference in kinetics of parasitemia between EHMI-8 and control volunteers as measured by PCR.
时间窗: 21 days
A significant quantitative difference in parasitemia as measured by PCR between EHMI-8 and control volunteers
时间窗: 21 days
次要结局
- Difference in immunological parameters between EHMI-8 and control volunteers.(140 days)