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.
Able and willing to complete the informed consent process
Available for the entire planned study duration
Male or Female
Aged 18 to 55 years
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
Single group
NF54/iGP3
Biological/VaccineMosquito-generated sporozoites of the genetically modified, inducible gametocyte-producing parasite line NF54/iGP3, created via CRISPR/Cas9 genetic engineering of the parental wildtype strain Plasmodium falciparum (Pf) NF54 to contain a trimethoprim (TMP)-inducible copy of the Pf gdv1 gene in the dispensable Pf cg6 locus.
To assess the infectivity, safety and tolerability of mosquito bite sporozoite challenge with NF54/iGP3 in healthy malaria-naïve participants by counting solicited and unsolicited adverse events.
Count the occurrence and assess the severity of local and systemic, solicited and unsolicited adverse events using CTCAE v5.0, following administration of NF54/iGP3 by mosquito bite.
To characterise the parasite growth profile of all blood stage parasites in participants following infection with NF54/iGP3 using qPCR (parasites/mL).
Measure the change in parasite count (parasites/mL) of blood-stage NF54/iGP3 parasites via qPCR, following inoculation until the administration of antimalarial treatment.
To characterise the post-treatment clearance profile of all blood stage parasites in participants following infection with NF54/iGP3 using qPCR (parasites/mL).
Measure the change in parasite count (parasites/mL) of blood-stage NF54/iGP3 parasites via qPCR, following administration of registered schizonticidal and gametocidal antimalarial treatments.
Measure the parasite count (parasites/mL) using qPCR in the participant's blood at the time of large volume blood withdrawal.
Measure the parasite count (parasites/mL) via qPCR in collected blood samples from study participants infected with NF54/iGP3, to determine the level of parasitemia.
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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
This trial is not recruiting at the moment. You can still explore other options:
