ACTRN12613001008718已完成1 期
A Pilot Study To Assess Mosquito Transmissibility of Plasmodium vivax In Participants Inoculated intravenously with the parasite Isolate Hmpbs-Pv
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years(—)
- 性别
- All
入选标准
- •1.Adults (males and non pregnant and non lactating females), aged between 18 and 50 years who do not live alone (from Day 0 until at least the end of the antimalarial drug treatment).
- •2.BMI within the range 18–30 kg/m2; weight greater than 50kg, with good peripheral venous access
- •3.Able and willing (in the Investigator’s opinion) to comply with all study requirements.
- •4.Non-smokers.
- •5.Female participants of childbearing potential must have adequate contraception in place.
- •6.Blood group A Duffy antigen positive.
排除标准
- •1.History of clinical malaria, or traveled to or lived (greater than 2 weeks) in a malaria-endemic country during the past 12 months.
- •2.Known severe reaction to mosquito bites other than local itching and redness.
- •3.Evidence of increased cardiovascular disease risk.
- •4.History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- •5.Being unwilling to defer blood donations for the duration of the trial and for at least 6 months after the end of their involvement in the study.
- •6.A history of clinically significant ECG abnormalities and known pre-existing prolongation of the QTc interval considered clinically significant.
- •7. Have ever received a blood transfusion.
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