Purified Plasmodium and vaccine composition
Inventors
Sim, B. Kim Lee • Li, Minglin • Stafford, Richard E. • Hoffman, Stephen L.
Assignees
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Publication Number
US-8821896-B2
Publication Date
2014-09-02
Expiration Date
Abstract
Disclosed are substantially purified Plasmodium sporozoites and preparations of Plasmodium sporozoites substantially separated from attendant non-sporozoite material, where the preparations of Plasmodium sporozoites have increasing levels of purity. Vaccines and pharmaceutical compositions comprising purified Plasmodium sporozoites are likewise provided. Methods of purifying preparations of Plasmodium sporozoites are also provided.
Core Innovation
The patent describes substantially purified, live (attenuated or pathogenic) Plasmodium sporozoite preparations with sharply reduced attendant non-sporozoite material (“attendant/SGM”). The purified preparations include vaccine/pharmaceutical compositions comprising such purified sporozoites.
The disclosed purified sporozoite preparations are described as metabolically active and non-attenuated, infectious Plasmodium sporozoites. The patent further describes residual attendant material constraints, including less than 85 nanograms of attendant material per 25,000 sporozoites.
The patent discloses purification methods using a defined series of size-exclusion/track-etched membrane filters, including differing nominal versus precise pore sizes and a filter train arrangement, to achieve low residual attendant material. The purification performance is quantified using an SGM-ELISA assay.
Claims Coverage
The independent claim covers conferring protective immunity in a human host against malaria caused by a Plasmodium-species parasite by administering a pharmaceutically suitable, aseptic, purified sporozoite preparation with limited attendant material, together with an antimalarial agent regimen effective against asexual erythrocytic stage parasites. The main inventive features are grounded in the preparation’s defined biological state, the species selection, the attendant-material threshold, and the concurrent antimalarial regimen.
Aseptic purified metabolically active, non-attenuated infectious Plasmodium sporozoites for protective immunity
Administering to a human host an aseptic, purified preparation of metabolically active, non-attenuated, infectious Plasmodium sporozoites to confer protective immunity against malaria caused by a Plasmodium-species parasite.
Selected Plasmodium species sporozoites
Using sporozoites selected from the group consisting of P. falciparum, P. vivax, P. malariae, P. ovale, P. knowlesi, and any combination thereof.
Concurrent antimalarial regimen effective against asexual erythrocytic stage parasites
Administering an antimalarial agent effective against asexual erythrocytic stage parasites concurrent with administering the purified sporozoite preparation.
Limited attendant material threshold for pharmaceutical suitability
Providing the purified preparation suitable for pharmaceutical use and comprising less than 85 nanograms of attendant material per 25,000 sporozoites.
The claim set centers on administering a pharmaceutically suitable, aseptic, purified sporozoite preparation that is metabolically active, non-attenuated, and infectious, with limited attendant material per defined number of sporozoites, selected among specified Plasmodium species, and administered concurrently with an antimalarial regimen effective against asexual erythrocytic stage parasites to confer protective immunity.
Stated Advantages
Confer protective immunity in a human host against malaria caused by a Plasmodium-species parasite.
Documented Applications
A method of conferring protective immunity in a human host against malaria caused by a Plasmodium-species parasite by administering purified, metabolically active, non-attenuated, infectious Plasmodium sporozoites together with an antimalarial agent regimen effective against asexual erythrocytic stage parasites.
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