Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Trial to Determine Safety and Protective Efficacy of Sanaria PfSPZ Challenge With Concurrent Pyrimethamine Treatment That Inhibits Development of Asexual B...

Chloroquine Phosphate is a 4-aminoquinoline compound that is commercially available for oral administration. It is a white, odorless, bitter tasting, crystalline substance freely soluble in water; and widely used for the treatment andprophylaxis of malaria. It is supplied and manufactured in tablets of 500 mg (equivalent to 300 mg chloroquine phosphaste base)

PYR is a folic acid antagonist that is commercially available; and has been commonly used as antimalarial drug for both treatment and prevention of malaria, usually in combination with sulfadoxine in adults, pregnant women, and children worldwide. It is manufactured in tablets of 25 mg.

Sanaria PfSPZ Challenge are aseptic, cryopreserved P.falciparum sporozoites used for CHMI trials, produced by the biotechnology company; Sanaria Inc. In brief, manufacture includes the production, under traditional environmental conditions, of eggs from a colony of A. stephensi mosquitoes housed in a controlled environmental chamber. The sporozoites are purified, counted, and, at a specified concentration, cryopreserved. Cryopreservation commences with the addition of cryoprotective additives to the purified sporozoites to produce the Sanaria PfSPZ Challenge product. Sanaria PfSPZ Challenge is dispensed into screw-cap vials containing 15,000, 50,000, or 100,000 PfSPZ in a 20 L aliquot. Sanaria PfSPZ Challenge is stored in liquid nitrogen vapour phase at 140 (Infinite)C to -196 (Infinite)C.