Clinical Trial

Disease: Malaria Infection, (NCT06881732)

Disease info:

Malaria is a mosquito-borne parasitic infection that remains life-threatening. Transmission occurs primarily via bites from infected female Anopheles mosquitoes, with occasional spread through blood transfusion or contaminated needles.

Early symptoms include fever, chills, and headaches. Without prompt treatment, particularly of Plasmodium falciparum infections, disease may escalate within 24 hours to severe manifestations such as respiratory distress, seizures or coma.

Those at highest risk include infants, young children, pregnant women, travellers to endemic areas and individuals with HIV/AIDS.

Five Plasmodium species infect humans.

P. falciparum is the most lethal and predominates in Africa.

P. vivax dominates outside sub-Saharan Africa.

P. malariae, P. ovale and P. knowlesi occur less frequently.

Effective control relies on vector avoidance (insecticide-treated nets, indoor spraying), chemoprophylaxis, and rapid antimalarial therapy to prevent progression from mild to severe disease.

- World Health Organization, Malaria

Frequency:
According to WHO’s latest World malaria report, there were an estimated 263 million cases and 597 000 malaria deaths worldwide in 2023.
Official title:
Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54/iGP3 GAP
Who:

Contact 

Name: Dana de Kretser

Phone: +61 (03) 9342 9401

Email: dana.dekretser@unimelb.edu.au

Sponsor:

University of Melbourne
 

Partners:

Walter and Eliza Hall Institute of Medical Research

Swiss Tropical & Public Health Institute

QIMR Berghofer Medical Research Institute

Locations:

Victoria, Australia

Doherty Clinical Trials, Melbourne, Victoria, Australia, 3002

Study start:
Jul. 1, 2025
Enrollment:
2 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Insertion of inducible gene overexpression cassette
Gene:
GDV1
Delivery method:
Plasmid - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

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.

Last updated: Sep. 20, 2025
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