Hybrid lt-a/ct-b holotoxin for use as an adjuvant
AssigneeThe Administrators of the Tulane Educational Fund
InventorJohn D Clements
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Abstract
The present invention provides a novel composition which is a hybrid heat labile enterotoxin comprising the A-subunit of the heat labile toxin of Escherichia coli (LT-A) and the B-subunit of the cholera enterotoxin of Vibrio cholerae (CT-B). The hybrid toxin is designated LT-A/CT-B. The LT-A subunit, the CT-B subunit, or both subunits of the hybrid toxin may be mutant subunits, e.g., differing from wild-type subunits by amino acid substitutions, deletions or additions. Also provided are methods of using the novel LT-A/CT-B comprising compositions of the invention as adjuvants for vaccines, methods of making the LT-A/CT-B hybrid holotoxin, and kits.
Claims22
A composition comprising a LT-A/CT-B hybrid enterotoxin holotoxin, which holotoxin has immunologic adjuvant activity and is substantially less toxic than native E. coli heat-labile enterotoxin holotoxin as measured in the patent mouse assay.
A kit useful in producing an immune response in a host to a pathogen comprising two components:
- (a) an effective amount of antigen and (b) an adjuvant effective amount of an LT-A/CT-B hybrid enterotoxin holotoxin, which holotoxin has immunologic adjuvant activity and is substantially less toxic than native E. coli heat-labile enterotoxin holotoxin as measured in the patent mouse assay.
A method of creating or sustaining an immune response to an antigen in a host comprising administering an admixture of an effective amount of an antigen and an adjuvant effective amount of an LT-A/CT-B hybrid enterotoxin holotoxin, which holotoxin has immunologic adjuvant activity and is substantially less toxic than native E. coli heat-labile enterotoxin holotoxin as measured in the patent mouse assay, in an orally acceptable pharmaceutical carrier.
A method of inducing an immune response to an antigen in a host comprising administering an effective amount of an antigen in conjunction with an adjuvant effective amount of an LT-A/CT-B hybrid enterotoxin holotoxin, which holotoxin has immunologic adjuvant activity and is substantially less toxic than native E. coli heat-labile enterotoxin holotoxin as measured in the patent mouse assay.
A method of inducing an immune response against an enterotoxic bacterial organism comprising administering an adjuvant effective amount of an LT-A/CT-B hybrid enterotoxin holotoxin, which holotoxin has immunologic adjuvant activity and is substantially less toxic than native E. coli heat-labile enterotoxin holotoxin as measured in the patent mouse assay, as a component of a vaccine directed against the enterotoxic bacterial organism.
Dependencies are inferred from the claim text.