About this trial
The goal of this clinical trial is to learn if the genetically-modified malaria parasite NF54/iGP3 will safely infect humans with malaria. The investigators will also determine how the parasite grows in humans, and the effect of anti-malarial drugs.
Researchers will use a controlled human malaria infection (CHMI) model to infect participants with malaria to observe the development of the disease, collect malaria-infected blood, and then treat the participants to cure the malaria infection.
The collected malaria-infected blood will be used to create a frozen stock of malaria parasites for use in future research.
Eligibility criteria
Qualifiers
Able and willing to complete the informed consent process
Available for the entire planned study duration
Male or Female
Aged 18 to 55 years
Disqualifiers
Participant lives alone and is unable provide contact details of a support person who is aware of the individual's participation in the study and is available to provide assistance if required
Participation in any investigational product study within the 12 weeks preceding inoculation
Positive urine drug test at screening or on the day of malaria inoculation unless there is an explanation acceptable to the Investigator (e.g. the volunteer has stated in advance that they consumed a prescription or over-the-counter product which contained the detected drug) and/or the volunteer has a negative urine drug screen on retest by the pathology laboratory
Positive alcohol breath test at screening or on the day of malaria inoculation
Trial design
Treatments tested in this trial
- NF54/iGP3
Treatment groups
Sponsors and collaborators
University of Melbourne
Lead sponsor
Walter and Eliza Hall Institute of Medical Research
Collaborator
Swiss Tropical & Public Health Institute
Collaborator
QIMR Berghofer Medical Research Institute
Collaborator