Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) Sporozoites
Status:
Completed
Trial end date:
2020-12-17
Target enrollment:
Participant gender:
Summary
This is a single-centre, open-label, Phase Ib study designed to assess if intravenous
injection of approximately 3200 P. falciparum (NF54 strain) sporozoites can be safely
administered to achieve blood-stage parasitaemia with a kinetics/PCR profile that will allow
for the future characterisation of antimalarial blood-stage activity of new chemical entities
in a relatively small number of participants during early drug development.
Healthy, malaria-naïve adults, aged 18-55 years, will be enrolled in a maximum of 2 cohorts.
Enrolment into the cohorts will proceed sequentially, with two target levels of parasitaemia,
i.e., 5000 parasites/mL blood in Cohort 1 and 10000 parasites/mL blood in Cohort 2.
(Based on observed levels of parasitaemia in Cohort 1, the target threshold for treatment in
Cohort 2 was maintained at 5,000 p/mL (vs 10,000 p/mL in the protocol)).
The 3-day antimalarial therapy regimen will be further administered and monitored until
parasite clearance. Safety and tolerability will be monitored during the whole study
duration.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
FGK Representative Service B.V., The Netherlands Institute of Tropical Medicine, Belgium Iqvia Pty Ltd PrimeVigilance Ltd., UK Sanaria Inc. SGS Life Sciences SGS Life Sciences, a division of SGS Belgium NV Swiss BioQuant A.G., Switzerland
Treatments:
Artemether Artemether, Lumefantrine Drug Combination Lumefantrine