Condition: Malaria (Plasmodium Falciparum) · Sponsor: Sanaria Inc.
This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa. The PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-/linup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress. Because Pf parasites with the LARC phenotype replicate in the liver before disintegrating, they amplify and diversify parasite protein expression and are expected to be a potent immunogen to induce anti-malarial immunity, equaling or exceeding the potency and efficacy of the replication-competent chemo-attenuated Sanaria® PfSPZ-CVac (chloroquine) vaccine approach. Because the parasites are intrinsically attenuated, they are expected to be safe and well tolerated, similar to radiation-attenuated Sanaria® PfSPZ Vaccine, to the replication deficient, early arresting PfSPZ-GA1 Vaccine, and to the single-gene(mei2)-deleted GA2 (LARC1) parasites tested at the Leiden University Medical Center that provided 90% protection against CHMI after a single dose. The active treatments to be assessed for efficacy are one immunization …
This description comes directly from the study's public registry record.
Prof Sodiomon Bienvenu SIRIMA, MD PhD · +226 7020 0444 · s.sirima@gras.bf
Dr Alphonse Ouedraogo, MD PhD · +22625355690 · a.ouedraogo@gras.bf
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| Groupe de Recherche Action en Santé (GRAS), Unité de Recherche Clinique de Banfora 06 BP 10248 | Ouagadougou, Burkina Faso | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07385287