Nontoxic mucosal adjuvant
AssigneeChiron Corporation
InventorRino Rappuoli
Life of this patent
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Abstract
A non-toxic mucosal adjuvant is provided which may be admixed with further antigens to provide a vaccine administrable to mucosal surfaces in organisms including man. Preferably, the non-toxic mucosal adjuvant is a detoxified mutant of a bacterial ADP-ribosylating toxin, optionally comprising one or more amino acid additions, deletions or substitutions.
Claims64
An immunogenic composition comprising an immunologically effective amount of an antigen selected from the group consisting of a viral antigen and a bacterial antigen, and
- a mucosal adjuvant, comprising a detoxified mutant A subunit of a cholera toxin (CT) or an E. coli heat labile toxin (LT1 or LT2), wherein said detoxified mutant comprises one or more amino acid substitutions as compared to wild-type sequence of said toxin, and wherein said mucosal adjuvant is not said antigen.
A method for the manufacture of composition comprising an antigen and a mucosal adjuvant, the method comprising the steps of:
- (a) performing site-directed mutagenesis on the A-subunit of a cholera toxin (CT) or an E. coli heat labile toxin (LTI and LT2) in order to detoxify said toxin;
- and (b) bringing said detoxified toxin into association with an antigen selected from the group consisting of a viral antigen and a bacterial antigen, such that said detoxified toxin functions as a mucosal adjuvant.
A method of enhancing an immune response to an antigen in a mammal comprising administering to said mammal an immunogenic composition comprising
- an immunologically effective amount of an antigen selected from the group consisting of a viral antigen and a bacterial antigen, and
- a mucosal adjuvant, wherein said mucosal adjuvant comprises a detoxified mutant A subunit of a cholera toxin (CT) or an E. coli heat labile toxin (LTI and LT2), wherein the detoxified mutant A subunit comprises an amino acid substitution in one or more residues of said toxin, and wherein said antigen is not said mucosal adjuvant.
Dependencies are inferred from the claim text.