An experimental study to characterize the in vivo safety and infectivity of the Plasmodium vivax isolate HMPBS02-Pv in humans
Blood stage challenge pilot study to assess the safety and the infectivity of Plasmodium vivax isolate HMPBS02-Pv in healthy volunteers.
QIMR Berghofer Medical Research Institute
2 participants
Sep 18, 2014
Interventional
Conditions
Summary
The goal of this single-centre study is to establish a ‘universal’, blood group O bank, of P. vivax infected human red blood cells (RBCs) for use in future malaria challenge studies. The study will use P. vivax HMPBS02-Pv challenge inoculum to infect two healthy participants in order to characterize the safety and infectivity of the parasite isolate P. vivax HMPBS02-Pv in vivo. Each participant will be inoculated on Day 0 with around 100 viable P. vivax-infected RBCs administered intravenously. The participants will be monitored for malaria symptoms firstly by phone, and then on an outpatient basis, for the unexpected early onset of malaria symptoms and for malaria parasites by PCR. On the day designated for commencement of treatment, as determined by PCR results and/or onset of clinical symptoms, participants will be admitted to the study unit and confined for safety monitoring and anti-malarial treatment (Riamet (Registered Trademark')) Following initiation of anti-malarial treatment, the participants will be monitored as in-patients for 48 hours to ensure tolerance of therapy and clinical response. Once clinically well, the participants will be followed up on an out-patient basis for continued dosing of anti-malarial drug, safety and clearance of malaria parasites via PCR. Follow up visits for safety assessments will be performed on Day 28 and Day 90 after malaria infection.
Eligibility
Inclusion Criteria5
- Healthy adults (male or female) subjects, who do not live alone (from Day 0 until at least the end of the antimalarial drug treatment) and be contactable and available for the duration of the trial (maximum of 4 months).
- Body weight, minimum 50.0 kg, body mass index between 18.0 and 32.0 kg/m2, inclusive.
- Female participants of childbearing potential should be blood group Rh positive and have adequate contraception in place.
- Able and willing (in the Investigator’s opinion) to give consent and comply with all study requirements.
- Non-smokers or smoking not more than 5 cigarettes per day and able to stop smoking during the confinement period in the study.
Exclusion Criteria7
- History of clinical malaria or participation to a previous malaria challenge studies, or travel to or lived (greater than 2 weeks) in a malaria-endemic country during the past 12 months.
- Has evidence of increased cardiovascular disease risk
- Pregnant or breast feeding
- History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- 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.
- A history of clinically significant ECG abnormalities and known pre-existing prolongation of the QTc interval considered clinically significant.
- Subject who has ever received a blood transfusion, and females of child bearing potential who are blood group Rh negative.
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Interventions
This is a single-centre study using a naturally acquired P. vivax HMPBS02-Pv challenge inoculum to infect healthy participants in order to characterize the in vivo infectivity of the parasite isolate P. vivax HMPBS02-Pv. This study will be conducted in two consenting and eligible participants. Each participant will be inoculated on Day 0 with around 100 viable P. vivax-infected human erythrocytes administered intravenously. On an outpatient basis, the participants will be monitored by PCR for presence of malaria parasites and for unexpected early onset of malaria symptoms, signs or parasitological evidence of malaria. On the day designated for commencement of treatment, participants will be admitted to the study unit and confined for safety monitoring and anti-malarial treatment with the antimalarial drug Riamet (artemether 20mg/lumefantrine 120mg). This treatment will be administered as an oral tablet; 6 doses of 4 tablets (total course 24 tablets) given over a period of 60 hours following food. All doses with exception of the last will be given under direct observation of clinical staff. It is expected the last dose is taken by participants at home. Participants will have a phone call from a study staff member to check on symptoms and ensure compliance/completion with treatment following the dose taken at home. At commencement of antimalarial treatment, the participants will be followed as inpatients for 48 hours to ensure tolerance of therapy and clinical response. Once clinically well, the participants will be followed up on an outpatient basis for continued dosing of anti-malarial drug, safety and clearance of malaria parasites via qPCR. Follow up visits for safety assessments will be performed on Day 28 and Day 90 after malaria infection and the participants are required to be contactable and available up to 2 weeks following this end of study visit. The overall period of participation will therefore be around 14 weeks from the time malaria infection.
Locations(1)
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ACTRN12614000930684