Apheresis of healthy subjects with induced blood stage Plasmodium vivax

Phase 1

Completed

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

• Registration Number: ACTRN12617001502325
• 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: 2017-10-25
• Study Completion: 2019-05-30
• Last Update Posted: 17 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1.Adult (male and non-pregnant, non-lactating female) subjects between 18 and 55 years of age, inclusive who do not live alone (from Day 0 until at least the end of the anti-malarial drug treatment) and will be contactable and available for the duration of the trial and up to 2 weeks following end of study visit.
2.Body mass index between 18.0 and 32.0 kg/m2, inclusive and a minimum body weight of 50 kg.
3.Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
4.Normal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position.
5.Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects enrolled in this study.
6.As there is the risk of adverse effects with artemether/lumefantrine and chloroquine in pregnancy, it is important that any subjects involved in this study do not get pregnant.
7.All subjects must be Duffy Blood group positive and have blood type O. Female subjects of childbearing potential should be blood group Rh positive.

Exclusion Criteria

1.Any history of malaria or participation in a previous malaria challenge study.
2.Must not have travelled to or lived (greater than 2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the study.
3.Has evidence of increased cardiovascular disease risk.
4.History of splenectomy.
5.Presence or history of drug hypersensitivity, or allergic disease diagnosed by an allergist/immunologist and/or treated by a physician for allergy or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
6.Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma, epilepsy, or obsessive compulsive disorder.
7.Frequent headaches and/or migraines, recurrent nausea, and/or vomiting (more than twice a month).
8.Presence of acute infectious disease or fever (e.g., sub-lingual temperature greater than or equal to 38.5 Degrees Celcius) within the 5 days prior to inoculation with malaria parasites.
9.Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise participant safety.
10.Participant has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, diarrhoea).
11.Participation in any investigational product study within the 12 weeks preceding the study.
12.Blood donation, any volume, within 1 month before inclusion, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to the Australian Red Cross Blood Service (Blood Service) or other blood bank during the 8 weeks preceding the treatment drug dose in the study.
13.Participant who has ever received a blood transfusion.
14.Any vaccination within the last 28 days.
15.Any recent ( less than 6 weeks) or current systemic therapy with an antibiotic or drug with potential anti-malarial activity (i.e. chloroquine, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, doxycycline etc.).
16.Cardiac/QT risk.
17.Known hypersensitivity to artemether/lumefantrine or chloroquine or any of thier excipients, or 4-aminoquinolines, artemether or other artemisinin derivatives, lumefantrine, piperaquine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified