MMV533 Plasmodium Falciparum Volunteer Infection Study

Inclusion Criteria

• Having given written informed consent prior to undertaking any study-related procedure.
• Male or female aged between 18 to 55 years inclusive.
• Available for the duration of the study and for 2 weeks following the End of Study Visit (EOS).
• Lives with a spouse, family member, or housemate from the time of inoculation with the malaria challenge agent through to the EOS.
• Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
• Willing to defer blood donations to a blood service for a minimum of 6 months after the EOS.
• Heterosexual women of childbearing potential (WOCBP) must agree to the use of a highly effective method of birth control (see below) combined with a barrier contraceptive from the screening visit until 30 days after the last dose of the IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last dose of IMP) and have a negative result on urine pregnancy test performed before inoculation with the malaria challenge agent.
• Women of non-childbearing potential (WONCBP)
• Males who have, or may have female sexual partners of child bearing potential during the course of the study must agree to use a double method of contraception including condom plus diaphragm, or condom plus intrauterine device, or condom plus stable oral/transdermal/injectable/implantable hormonal contraceptive by the female partner, from the time of informed consent through to 60 days (covering a spermatogenesis cycle) after the last dose of the IMP. Abstinent males must agree to start a double method if they begin sexual relationship with a female during the study and up to 60 days after the last dose of study drug. Males with female partners of child-bearing potential that are surgically sterile, or males who have undergone sterilisation and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception.
• Vital signs after 5 minutes resting in supine position:
• Systolic blood pressure (SBP) - 90-140 mmHg,
• Diastolic blood pressure (DBP) - 40-90 mmHg,
• Heart rate (HR) 40-100 bpm.

At Screening and pre-inoculation with the malaria challenge agent: normal standard mean of triplicate 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges:

• QT ≤ 500 msec,
• QT Interval Corrected Using Fridericia's Formula (QTcF) QTcF ≤ 450 msec, QT Interval Corrected Using Bazett's Formula (QTcB) QTcB ≤ 450 msec
• PR interval ≤ 210 msec for both males and females, and
• Normal ECG tracing unless the Principal Investigator or delegate considers an ECG tracing abnormality to be not clinically relevant.
• In the opinion of the Principal Investigator or delegate, the individual has a high probability of adherence with and completion of the study, and willing and able to withdraw and refrain from restricted medications.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Fluent in English and able to understand and comply with written and verbal protocol-related requirements.
• Agrees to adhere to the lifestyle considerations throughout the study (see Section 4.3.3) and is willing to consume 240 mL full-fat milk with each dose of rescue medication Riamet®.

Exclusion Criteria

• Any lifetime history of malaria or participation in a previous malaria challenge study or malaria vaccine trial.
• Must not have had malaria exposure that is considered significant by the Principal Investigator or delegate. This includes but is not limited to:
• history of having travelled to or lived (> 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 trial;
• history of having lived for >1 year in a malaria-endemic region in the past