Compositions and methods for treating intracellular diseases

Abstract

The present invention provides methods of treating intracellular infections comprising the step of administering a vector construct which directs the expression of at least one immunogenic portion of an antigen derived from an intracellular pathogen, and also administering to the warm-blooded animal a protein which comprises the immunogenic portion of the antigen, such that an immune response is generated.

1 . An immunogenic composition comprising
 (a) a replication incompetent vector construct, which comprises a polynucleotide encoding at least one immunogenic portion of an antigen from an intracellular pathogen; and   (b) a protein, which comprises at least one immunogenic portion of the antigen from the intracellular pathogen.   
     
     
         2 . The composition of  claim 1  further comprising a pharmaceutically acceptable carrier or diluent. 
     
     
         3 . The composition of  claim 1  further comprising an immunomodulatory co-factor. 
     
     
         4 . The composition of  claim 1  wherein the antigen is from a Hepatitis C virus (HCV), a Hepatitis B Virus (HBV), or a Human Immunodeficiency Virus (HIV). 
     
     
         5 . The composition of  claim 4  wherein the antigen is a Hepatitis C virus antigen selected from the group consisting of: a core C antigen, an E1 antigen, an E2/NS1 antigen, an NS2 antigen, an NS3 antigen, an NS4 antigen, and an NS5 antigen. 
     
     
         6 . The composition of  claim 4  wherein the antigen is a Hepatitis B virus antigen selected from the group consisting of: an HBeAg antigen, an HBcAg antigen, an HBsAg antigen, an HBxAg antigen, an ORF5 antigen, an ORF6 antigen and an HBV Pol antigen. 
     
     
         7 . The composition of  claim 4  wherein the antigen is a Human Immunodeficiency Virus (HIV) antigen. 
     
     
         8 . The composition of  claim 1  wherein the non-replicating vector construct is selected from the group consisting of: an alphavirus vector construct, an adeno-associated virus vector construct, a parvovirus vector construct, and a retrovirus vector construct. 
     
     
         9 . The composition of  claim 1  wherein the non-replicating vector construct is a eukaryotic layered vector initiation system (ELVIS) construct. 
     
     
         10 . A method for treating intracellular infections in a warm-blooded animal, comprising:
 (a) administering a replication-incompetent vector construct to the animal,   wherein the vector construct comprises a polynucleotide that encodes at least one immunogenic portion of an antigen obtained from an intracellular pathogen; and   (b) administering a protein to the animal,   wherein the protein comprises at least one immunogenic portion of the antigen obtained from the intracellular pathogen.   
     
     
         11 . The method of  claim 10  wherein the protein is administered prior to administering the vector construct. 
     
     
         12 . The method of  claim 10  wherein the intracellular pathogen is a virus. 
     
     
         13 . The method of  claim 10  wherein the antigen is a Hepatitis C virus antigen selected from the group consisting of: a core C antigen, an E1 antigen, an E2/NS1 antigen, an NS2 antigen, an NS3 antigen, an NS4 antigen, and an NS5 antigen. 
     
     
         14 . The method of  claim 10  wherein the antigen is a Hepatitis B virus antigen selected from the group consisting of: an HBeAg antigen, an HBcAg antigen, an HBsAg antigen, an HBxAg antigen, an ORF5 antigen, an ORF6 antigen and an HBV Pol antigen. 
     
     
         15 . The method of  claim 10  wherein the intracellular pathogen is a parasite. 
     
     
         16 . The method of  claim 10  wherein an immunomodulatory co-factor is co-administered with the vector construct. 
     
     
         17 . The method of  claim 10  wherein an immunomodulatory co-factor is co-administered with the protein. 
     
     
         18 . The method of  claim 10  wherein the non-replicating vector construct is selected from the group consisting of: an alphavirus vector construct, an adeno-associated virus vector construct, a parvovirus vector construct, and a retrovirus vector construct. 
     
     
         19 . The method of  claim 10  wherein the non-replicating vector construct is a eukaryotic layered vector initiation system (ELVIS) construct.