An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7Pf

Queensland Institute of Medical Research0 个研究点目标入组 2 人开始时间: 2013年6月19日最近更新: 2020年1月13日

适应症

试验速览

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•1. Participants will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
•2. Participants must have a BMI within the range 18–30 kg/m2.
•3. Participants must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
•4. Be contactable and available for the duration of the trial (maximum of 4 weeks).
•5. Participants must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
•6. Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
•7. Good peripheral venous access.

•1. History of malaria or tavelled to or lived (greater than 2 weeks) in a malaria-endemic country during the past 12 months
•2. Has evidence of increased cardiovascular disease risk
•3. History of splenectomy.
•4. History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
•5. Presence of current or suspected serious chronic diseases or significant intercurrent disease of any type
•6. Unwilling to defer blood donations for 6 months.
•7. Recent or current therapy with an antibiotic or drug with potential antimalarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc.).
•8. Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6
•9. Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants.
•10. Presence of acute infectious disease or fever
•15. Evidence of acute illness within the four weeks before trial prior to screening.
•11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
•12. A history of drug habituation, or any prior intravenous usage of an illicit substance.
•13. Medical requirement for intravenous immunoglobulin or blood transfusions.
•14. Participation in any investigational product study within the 8 weeks preceding the study.
•15. Any clinically significant biochemical or haematologic abnormality
•16. Vital signs outside the reference range and clinically significant.

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