Yellow Fever Human Infection Model With YF-17D
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- yellow fever 17D in urine
研究概览
简要总结
No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.
详细描述
No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-50 years
排除标准
- •contraindication to receive YF-17D (immune deficiency, thymus illness)
- •previous YF vaccination
- •pregnancy
- •chicken egg allergy
- •hypersensitivity to any other substance in the YF-17D vaccine
- •interval of < 4 weeks of another live attenuated vaccine
研究组 & 干预措施
intervention arm
yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril)
干预措施: Yellow Fever Vaccine (Drug)
结局指标
主要结局
yellow fever 17D in urine
时间窗: within 30 days of the vaccination
yellow fever 17D in urine at sequential time points after vaccination
次要结局
- peak of YF 17D viruria after vaccination(within 30 days of the vaccination)
- YF-17D viremia (in plasma) after vaccination(within 14 days of the vaccination)
研究者
Anna HE Roukens
Principal Investigator
Leiden University Medical Center