An experimental study to investigate the transmission of malaria from a person infected with a specific species of malaria to mosquito feeding on that infected person’s blood

Phase 1

Completed

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

• Registration Number: ACTRN12613001008718
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the P. vivax induced blood stage malaria (IBSM) model with subsequent experimental mosquito feeding as a system to study infectivity to vector mosquitoes.<br>Assessed by: mid gut dissection of mosquitoes and microscopic visualization, to evaluate the production of oocysts<br>[Timepoint: 7-8 days after feeding];To assess the safety of the P. vivax blood stage malaria (IBSM) model in healthy malaria-naive volunteers <br>Assessed by close monitoring of clinical status, including physical examination vital signs electrocardiograms (ECG) and by laboratory pathology testing, including hematology, chemistry, and serology.<br>[Timepoint<br>Adverse event (such as fever fatigue, vomiting and diarrhea) screening through to Day 16, Day 28 <br>Hematology, biochemistry : screening, Day 0,14 16 28<br>ECG and Serology: Screening and Day 28 <br>Physical examination and vital signs: Screening, Day 0 and 7-28<br>]

Secondary Outcome Measures

Name	Time	Method
To further characterize the parasite growth curves after I.V. inoculation of healthy participants with P. vivax blood stage parasites.<br>Assessed by: PCR testing of collected blood <br>[Timepoint: Day 7-14];To further characterize the parasite clearance profiles by PCR after administration of antimalarial drug after inoculation with P. vivax blood stage parasites.<br>Assessed by: PCR testing of collected blood<br>[Timepoint: Day 14-16, 28]