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

NCT06881732 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Malaria Falciparum
  • Malaria Infection
  • Malaria Transmission

Interventions

BIOLOGICAL

NF54/iGP3

Mosquito-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.

Sponsors & Collaborators

  • Walter and Eliza Hall Institute of Medical Research

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • QIMR Berghofer Medical Research Institute

    collaborator OTHER

  • University of Melbourne

    lead OTHER

Principal Investigators

  • James McCarthy · University of Melbourne

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06881732 on ClinicalTrials.gov