Genetic immunization with nonstructural proteins of hepatitis C virus

Abstract

Nucleic acid molecule that comprise a hepatitis C nonstructural protein including specifically disclosed DNA sequences are disclosed. Pharmaceutical compositions that contain nucleic acid molecules comprising a hepatitis C nonstructural protein including a nucleotide sequence encoding NS3, NS4, or NS5, or a combination thereof, operably linked to regulatory elements functional in human cells are disclosed. Methods of immunizing individuals susceptible to or infected by hepatitis C virus comprising administering such pharaceutical compositions are disclosed.

1 - 34 . (canceled)  
   
   
       35 . A pharmaceutical composition comprising 
 a recombinant nucleic acid molecule comprising a nucleotide sequence encoding hepatitis C virus nonstructural proteins NS3, NS4 or NS5, or a combination thereof, wherein said nucleotide sequence is operably linked to regulatory elements, and    a pharmaceutically acceptable carrier or diluent.    
   
   
       36 . The pharmaceutical composition of  claim 35  wherein said recombinant nucleic acid encodes a fusion protein encoding hepatitis C virus nonstructural proteins NS3, NS4 or NS5, or a combination thereof.  
   
   
       37 . The pharmaceutical composition of  claim 35  wherein said recombinant nucleic acid consists of a nucleotide sequence encoding hepatitis C virus nonstructural proteins NS3, NS4 and NS5, operably linked to regulatory elements, said regulatory elements comprising a promoter, enhancer, polyadenylation sequence, and a hepatitis C virus 5′ untranslated region (5′-UTR).  
   
   
       38 . The recombinant nucleic acid molecule of  claim 37  wherein said 5′-UTR comprises at least the 9 most 3′ nucleotides of a 5′-UTR of hepatitis C virus.  
   
   
       39 . The pharmaceutical composition of  claim 37  wherein said promoter is a cytomegalovirus promoter and said enhancer is a Rous Sarcoma Virus enhancer.  
   
   
       40 . The pharmaceutical composition of  claim 35  wherein said nonstructural proteins NS3, NS4 or NS5 are at least 50 amino acids in length.  
   
   
       41 . The pharmaceutical composition of  claim 35  wherein said nucleotide sequence is operably linked to regulatory elements, said regulatory elements comprising a promoter, enhancer, polyadenylation sequence, and a hepatitis C virus 5′ untranslated region (5′-UTR).  
   
   
       42 . The recombinant nucleic acid molecule of  claim 41 , wherein said 5′-UTR comprises at least the 9 most 3′ nucleotides of a 5′-UTR of hepatitis C virus.  
   
   
       43 . The pharmaceutical composition of  claim 41  wherein said promoter is a cytomegalovirus promoter and said enhancer is a Rous Sarcoma Virus enhancer.  
   
   
       44 . The method of  claim 35  wherein said pharmaceutical composition further comprises a facilitator.  
   
   
       45 . The method of  claim 44  wherein said facilitator is bupivacaine.