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

Phase 1

Completed

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12613000669796
• Lead Sponsor: Queensland Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the in vivo infectivity of QIMR3D7Pf in healthy volunteers, following infection with in vitro expanded blood stage P. falciparum parasites.<br>This outcome is assessed though regular PCR blood tests [Timepoints day 5- day 28 <br>]

Secondary Outcome Measures

Name	Time	Method
To confirm the parasite growth curves after I.V. inoculation of healthy volunteers with in vitro expanded blood stage P. falciparum strain 3D7 malaria parasites; This outcome is assessed though regular PCR blood tests [Timepoints day 5- day 28];To establish the parasite clearance profiles by PCR after administration of antimalarial drug at a target parasitemia of =1,000 parasites/mL after inoculation with an experimental malaria challenge; This outcome is assessed though regular PCR blood tests[Timepoints day 5- day 28];To assess the safety of an experimental malaria challenge using in vitro expanded blood stage parasites. This outcome is assessed though clinical assessment (history, vital signs, and physical examination), as well as urinalysis, haematology biochemistry and red cell alloantibody evaluation [Timepoint 90 DAYS]