Condition: Malaria Falciparum · Sponsor: Sanaria Inc.
This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria infection (CHMI). PfSPZ-LARC2 Vaccine contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites). The primary objective of the study is to assess the safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population.
This description comes directly from the study's public registry record.
Peter Kremsner, MD · +49 7071 2987197 · peter.kremsner@uni-tuebingen.de
Andrea Kreidenweiss, PhD · +49 7071 2985569 · andrea.kreidenweiss@uni-tuebingen.de
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| University of Tubingen | Tübingen, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06862453