At a glance
ClinicalIndex Comparison Record- ✓Age 18–55 years, inclusive
- ✓Body weight ≥50 kg and BMI 18.0–32.0 kg/m²
- ✓Certified healthy by comprehensive clinical assessment and normal vital signs: SBP 90–140 mmHg, DBP 50–90 mmHg, HR 40–100 bpm
- ✓Normal 12-lead ECG with QTcF ≤450 ms average, no second/third degree AV block or abnormal T wave morphology
- ✕Any prior history of malaria or participation in a previous malaria challenge study
- ✕Travel to or residence (>2 weeks) in a malaria-endemic country in the past 12 months or planned travel during study
- ✕Known severe reaction to mosquito bites other than local itching and redness
- ✕Cardiovascular disease risk >10% (5-year risk) per Gaziano method based on age, sex, SBP, smoking, BMI, diabetes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Blood Stage Challenge Study to Asses Mosquito Transmissibility in Participants Inoculated With Plasmodium Falciparum
In Brief
A Phase 1 clinical trial evaluating Administration of the malaria inoculum and Piperaquine Phosphate 480 mg for Malaria. Completed, enrolled 6 participants across 1 site.
Detailed Summary
This is a single-centre, open-label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that treatment of participants with the antimalarial drug piperaquine, in addition to effectively clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this purpose, experimental mosquito feeding directly on participants and artificial membrane mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per cohort). Subsequent cohorts will not commence until at least after day 28 of the previous cohort and review by Safety Review Team. This interval will also allow cohorting of experimental infection of mosquitoes to optimise logistics and enable iterative improvements in the system if applicable.
Study Details
Timeline
Interventions
Each participant in the cohort will be inoculated on Day 0 with \~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.
When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate