Antigenic compositions

Abstract

The invention relates to antigenic compositions and to methods for immunising animals using same. The antigenic compositions comprises a lipid formulation most usually in solid form, and at least one antigenic component. A preferred antigenic component is a living organism. In a preferred embodiment the composition is formulated for oral administration.

1 . An immunogenic composition comprising a pharmaceutically acceptable lipid formulation and at least one immunogenic component comprising an immunogenically effective amount of live organisms, said lipid formulation being a lipid matrix in a solid or paste form and the live organisms being uniformly dispersed throughout the lipid matrix, said composition further comprising an additional lipid. 
     
     
         2 . The composition of  claim 1 , said composition having a solid to fluid transition temperature between about 10° C. to 40° C. 
     
     
         3 . The composition of  claim 1 , said composition having a solid to fluid transition temperature between about 30° C. and about 40° C. 
     
     
         4 . An immunogenic composition comprising a pharmaceutically acceptable lipid formulation having a solid to fluid transition temperature of between about 10° C. and about 40° C., and at least one immunogenic component present in an immunogenically effective amount, said lipid formulation being a lipid matrix in a solid form or paste form and the immunogenic component being uniformly dispersed throughout the lipid matrix, said composition further comprising an additional lipid. 
     
     
         5 . The composition of  claim 4 , said composition having a solid to fluid transition temperature between about 30° C. and about 40° C. 
     
     
         6 . The composition of  claim 4 , said immunogenic component comprising live organisms, a protein, glycoprotein, peptide, or mixtures thereof. 
     
     
         7 . The composition of  claim 6 , said immunogenic component being isolated and/or purified. 
     
     
         8 . The composition of  claim 4 , further comprising an aqueous solution and an emulsifier. 
     
     
         9 . The composition of  claim 4 , further comprising an aqueous solution, an emulsifier, and a buffer. 
     
     
         10 . The composition of  claim 4  which is formulated for oral administration. 
     
     
         11 . The composition of  claim 1  wherein the live organisms are a biologically pure culture. 
     
     
         12 . The composition of  claim 6  wherein the live organisms are a biologically pure culture. 
     
     
         13 . The composition of  claim 1  wherein the live organisms are selected from the group consisting of fungi, protozoa, bacteria, and viruses. 
     
     
         14 . The composition of  claim 13  wherein the virus is HIV or SIV. 
     
     
         15 . The composition of  claim 13  wherein the bacteria is selected from  Brucella,  Anthrax, and  Mycobacterium.    
     
     
         16 . The composition of  claim 15  wherein the bacteria is  Mycobacterium.    
     
     
         17 . The composition of  claim 16  wherein the  Mycobacterium  is selected from  M. tuberculosis  complex (comprising  M. tuberculosis, M. bovis, M. africanum  and  M. microtii )  M. avium - intracellulare  complex (comprising  M. intracellulare  and  M. avium ),  M. paratuberculosis, M. vaccae, M. smegmatis, M. chelonae, M. fortiutum, M. kansasii, M. leprae, M. marinum, M. ulcerans, M. simiae, M. haemophilum, M. malmoense, M. shimoidei, M. gastri, M. terrae  complex, and  M. monchromogenicum,  including functionally equivalent variants, natural or genetically engineered clones, mutants, and recombinants of these strains, and immunogenic components thereof. 
     
     
         18 . The composition of  claim 1 , said additional lipid comprising 90% to 100%, C 16  and/or C 18  fatty acids. 
     
     
         19 . The composition of  claim 1 , said lipid formulation having the formula: 3% myristic acid; 26% palmitic acid; 15% stearic acid; 40% oleic acid; and 6% linoleic acid. 
     
     
         20 . The composition of  claim 1  which has less than about 10% aqueous components. 
     
     
         21 . The composition of  claim 1  which has less than about 5% aqueous components. 
     
     
         22 . The composition of  claim 4 , said composition having a solid to fluid transition temperature between about 30° C. to 37° C. 
     
     
         23 . The composition of  claim 4 , said additional lipid being 90% to 100% C 16  and/or C 18  fatty acids. 
     
     
         24 . The composition of  claim 4  said lipid formulation having the formula: 3% myristic acid; 26% palmitic acid; 15% stearic acid; 40% oleic acid; and 6% lineolic acid. 
     
     
         25 . The composition of  claim 1  further comprising one or more flavoring agents, attractants or odorants. 
     
     
         26 . The composition of  claim 1 , said lipid formulation comprising 47% lauric acid, 20% myristic acid, 12% palmitic acid, 12% stearic acid, and 3% oleic acid. 
     
     
         27 . The composition of  claim 1 , said lipid matrix being a coconut oil. 
     
     
         28 . The composition of  claim 4 , said lipid matrix being a coconut oil. 
     
     
         29 . The composition of  claim 4 , said lipid formulation comprising 47% lauric acid, 20% myristic acid, 12% palmitic acid, 12% stearic acid, and 3% oleic acid. 
     
     
         30 . The composition of  claim 4  comprising less than about 10% aqueous components. 
     
     
         31 . The composition of  claim 4  comprising less than about 5% aqueous components. 
     
     
         32 . The composition of  claim 4 , further comprising one or more flavoring agents, attractants or odorants. 
     
     
         33 . A method for immunizing an animal, the method comprising administering to said animal a composition according to  claim 1 . 
     
     
         34 . A method for immunizing an animal, the method comprising administering to said animal a composition according to  claim 4 . 
     
     
         35 . The method of  claim 33 , said composition being administered parenterally. 
     
     
         36 . The method of  claim 33 , said composition being administered subcutaneously. 
     
     
         37 . The method of  claim 34 , said animal being human. 
     
     
         38 . The method of  claim 34 , said animal being a cattle, deer, sheep, possum or badger. 
     
     
         39 . A method for manufacturing an immunogenic composition, comprising:
 dispeersing an antigen in the lipid formulation of  claim 1  by one or more of mixing or shaking, said antigens being uniformly dispersed throughout said lipid formulation.   
     
     
         40 . A method for manufacturing an immunogenic composition, comprising:
 dispersing an antigen in the lipid formulation of  claim 4  by one or more of mixing or shaking, said antigens being uniformly dispersed throughout said lipid formulation.