Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model
Status:
Completed
Trial end date:
2019-06-03
Target enrollment:
Participant gender:
Summary
This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to
evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P.
falciparum sporozoite infection model.
Healthy men and women, aged 18 to 45 years were to be enrolled in 3 study cohorts and to be
administered either P218 or placebo twice, 48 hours apart. Subjects in cohorts 2 and 3 were
to be inoculated with P. falciparum sporozoites. Enrolment in cohorts was to proceed
sequentially, to facilitate review of data by a Safety Review Team (SRT) before proceeding
with a subsequent cohort.
In cohort 1, safety and tolerability of P218 was assessed. In cohorts 2 and 3,
chemoprotective activity of P218 against malaria infection was assessed, as well as the
Influence of time of initiation of the P218 treatment on the protective effect.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Biologic LLP, UK FGK Representative Service B.V., The Netherlands Institute of Tropical Medicine, Belgium PrimeVigilance Ltd., UK Sanaria Inc. SGS Life Sciences SGS Life Sciences, a division of SGS Belgium NV Swiss BioQuant A.G., Switzerland Washington University School of Medicine