Purified plasmodium and vaccine compositions
Inventors
Sim, B. Kim Lee • Li, Minglin • Stafford, Richard E. • Hoffman, Stephen L.
Assignees
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Publication Number
US-8043625-B2
Publication Date
2011-10-25
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
A purified preparation of Plasmodium-species sporozoites is provided that comprises less than 85 nanograms of attendant material per 25,000 sporozoites. The document defines substantially purified by an attendant-material criterion, with lower thresholds described for preferred embodiments. The purified preparations are characterized as aseptically prepared in an excipient.
Purification is performed to remove attendant non-sporozoite material, including salivary gland material (SGM). A size-exclusion filtration purification scheme is described that reduces attendant material while maintaining sporozoite viability in excipient. Purification performance is quantified by attendant-material reduction.
Attenuated sporozoites are described in the malaria vaccine platform by attenuation via radiation exposure, so that potency is achieved in metabolically active hepatocyte invasion without progression beyond the liver stage. Potency is assessed using PfLSA-1 expression in human hepatocyte cultures. Vaccine/pharmaceutical compositions are described using the purified attenuated sporozoites, and purified pathogenic sporozoites are described for use as research/challenge materials.
Claims Coverage
The partial content provides one independent claim. The claim is directed to a purified preparation of Plasmodium-species sporozoites defined by an attendant-material threshold per number of sporozoites, with dependent refinements indicated for tighter numerical limits and related preparation and attenuation constraints.
Purified preparation of Plasmodium-species sporozoites with limited attendant material
A purified preparation of Plasmodium-species sporozoites comprising less than 85 nanograms of attendant material per 25,000 sporozoites.
Across the independent claim and indicated dependent refinements, the core claim element is a purified Plasmodium sporozoite preparation constrained by low attendant material per 25,000 sporozoites, with further described refinements that tighten the attendant-material limits and specify additional preparation/attenuation-related characteristics.
Stated Advantages
Reduces attendant material in sporozoite preparations to substantially purified levels.
Documented Applications
Research/challenge materials using purified pathogenic sporozoites.
Malaria vaccine/pharmaceutical compositions using the purified attenuated sporozoites.
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