Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54/iGP3 GAP

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Melbourne

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

2 Participants
are divided into 1 treatment group

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