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Plasmodium falciparum, strain NF54, sporozoites is an investigational substance with no marketing authorisation in the product records.[1] Its product name in the registry is PfSPZ Challenge (NF54), supplied by University Hospital Tuebingen.[1] The substance is classified under parasitic diseases in the registry and is used as a test agent in one trial.[1] Sporozoites are the parasite stage transmitted by mosquito bites; they first infect the liver before releasing forms that invade red blood cells and cause malaria disease.[2]
Sporozoites are formed inside oocysts in the mosquito midgut and become fully infectious after colonising the insect salivary glands, where they remain quiescent until transmission.[2] When injected intravenously into a volunteer, the sporozoites travel to the liver, transform into replicative forms, and subsequently release thousands of merozoites that invade red blood cells and initiate malaria.[2] In challenge studies, this deliberate exposure lets researchers test whether a preventive medicine stops the parasite from establishing a blood-stage infection.
PfSPZ Challenge (NF54) is a solution for injection given by intravenous injection.[1] In the registered trial, the challenge dose was 3200 sporozoites administered intravenously.[1] The registry also notes that in one product record the substance is part of a fixed combination.[1]
One completed Phase 2 trial investigated PfSPZ Challenge (NF54) in malaria.[1] The study enrolled 32 healthy, non-immune volunteers and tested whether a weekly oral dose of atovaquone-proguanil (250/100 mg) could protect against malaria after intravenous challenge with PfSPZ Challenge (NF54).[1] The primary efficacy endpoint was the proportion of protected volunteers, defined as the absence of amplifying parasitaemia — a rising number of parasites in the blood — for 21 days after challenge.[1] The study also measured a primary safety endpoint relating to the number of adverse events.[1]
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