Autoantigen composition

Abstract

The invention features methods for the prevention or treatment of autoimmune disorders in humans. The methods include administering an autoantigen in combination with an oil-based carrier. Included are methods for the prevention and treatment of diabetes mellitus which include treating a patient with a diabetes type 1 autoantigen, e.g., human insulin B-chain or GAD65, and an oil-based carrier approved for human use. Also included are vaccines and kits for the treatment of diabetes mellitus.

What is claimed is:  
     
         1 . A method for the prevention or treatment of diabetes comprising: administering to a human subject in need of prevention or treatment, a pharmaceutical composition comprising a Type 1 diabetes autoantigen or immunologically active fragment or variant thereof and an oil-based carrier.  
     
     
         2 . The method of  claim 1 , wherein the autoantigen is selected from the group consisting of: preproinsulin, GAD 65, ICA512/IA-2, HSP60, carboxypeptidase H, peripherin, and ganglioside.  
     
     
         3 . The method of  claim 1 , where the autoantigen is preproinsulin or an immunologically active fragment or variant thereof.  
     
     
         4 . The method of  claim 3 , wherein the autoantigen is human insulin B-chain or an immunologically active fragment or variant thereof.  
     
     
         5 . The method of  claim 4 , wherein the insulin B-chain fragment comprises amino acids 33-37 of SEQ ID NO:1.  
     
     
         6 . The method of  claim 1 , wherein the autoantigen is GAD65 or an immunologically active fragment or variant thereof.  
     
     
         7 . The method of  claim 1 , wherein the pharmaceutical composition is a vaccine.  
     
     
         8 . The method of  claim 1 , wherein the autoantigen is a synthetic peptide.  
     
     
         9 . The method of  claim 1 , wherein the oil based carrier is IFA or Montamide ISA or an equivalent composition.  
     
     
         10 . A pharmaceutical composition comprising a type 1 diabetes autoantigen and an oil-based adjuvant.  
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein the autoantigen is selected from the group consisting of: preproinsulin, GAD 65, ICA512/IA-2, HSP60, carboxypeptidase H, peripherin, and ganglioside.  
     
     
         12 . The pharmaceutical composition of  claim 10 , wherein the autoantigen is preproinsulin or an immunologically active fragment thereof.  
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein the autoantigen is human insulin B-chain or an immunologically active fragment or variant thereof.  
     
     
         14 . The pharmaceutical composition of 13, wherein the insulin B-chain fragment comprises amino acids 33-37 of SEQ ID NO: 1.  
     
     
         15 . The pharmaceutical composition of  claim 10 , wherein the autoantigen is GAD65 or an immunologically active fragment or variant thereof.  
     
     
         16 . The pharmaceutical composition of  claim 10 , wherein the autoantigen is a synthetic peptide.  
     
     
         17 . The pharmaceutical composition of  claim 10 , wherein the oil-based adjuvant is IFA or Montamide ISA or an equivalent composition.  
     
     
         18 . The pharmaceutical composition of  claim 13 , wherein the human insulin B-chain is solubilized in urea.  
     
     
         19 . A kit for preventing or treating type 1 diabetes comprising: a human type 1 diabetes autoantigen or immunologically active fragment or variant thereof, an oil-based carrier, and instructions indicating suitability for human use.  
     
     
         20 . The kit of  claim 19 , wherein the autoantigen is selected from the group consisting of: preproinsulin, GAD 65, ICA512/IA-2, HSP60, carboxypeptidase H, peripherin, and ganglioside.  
     
     
         21 . The kit of  claim 19 , wherein the autoantigen is a synthetic peptide.  
     
     
         22 . The kit of  claim 19 , wherein the autoantigen is lyophilized.  
     
     
         23 . The kit of  claim 19 , wherein the autoantigen is human insulin B-chain or an immunologically active fragment or variant thereof.  
     
     
         24 . The kit of  claim 19 , wherein the oil-based carrier is IFA or Montamide ISA or an equivalent composition.  
     
     
         25 . A method of enabling a health care provider to prevent or treat type 1 diabetes in a human subject, the method comprising: 
 providing a health care provider with a human diabetes type 1 autoantigen or immunologically active fragment or variant thereof;    optionally providing the health care provider with an oil-based carrier; and    providing the health care provider with instructions for use of the autoantigen to treat the subject.    
     
     
         26 . The method of  claim 25 , wherein the autoantigen is selected from the group consisting of: preproinsulin, GAD 65, ICA512/IA-2, HSP60, carboxypeptidase H, peripherin, and ganglioside.  
     
     
         27 . The method of  claim 25 , wherein the autoantigen is a synthetic peptide.  
     
     
         28 . The method of  claim 25 , wherein the autoantigen is lyophilized.  
     
     
         29 . The method of  claim 25 , wherein the autoantigen is human insulin B-chain or an immunologically active fragment or variant thereof.  
     
     
         30 . The method of  claim 25 , wherein the oil-based carrier is IFA or Montanide ISA or an equivalent composition.