Method to enhance an immune response of nucleic acid vaccination

Abstract

This invention provides a method to enhance an immune response of nucleic acid vaccination by simultaneous administration of a polynucleotide and a polypeptide of interest.

What is claimed is:  
     
         1 . A method to enhance an immune response of nucleic acid vaccination by simultaneous administration of: (i) a polynucleotide encoding for a polypeptide of interest; and (ii) the polypeptide of interest.  
     
     
         2 . The method of  claim 1  wherein the nucleic acid is DNA.  
     
     
         3 . The method of  claim 1  wherein the nucleic acid is RNA.  
     
     
         4 . The method of  claim 2  wherein the DNA and protein are admixed.  
     
     
         5 . The method of  claim 1  wherein the polypeptide is administered 0-10 days after the polynucleotide.  
     
     
         6 . The method of  claim 5  wherein the polypeptide is administered within 3-7 days after the polynucleotide.  
     
     
         7 . The method of  claim 1  wherein the polypeptide is presented in a delayed release formulation and administered at the same time as the polynucleotide.  
     
     
         8 . A method to enhance an immune response of polypeptide vaccination by simultaneous administration of: (i) a nucleic acid encoding for a polypeptide of interest; and (ii) the polypeptide of interest.  
     
     
         9 . The method of  claim 8  wherein the nucleic acid is DNA.  
     
     
         10 . The method of  claim 8  wherein the nucleic acid is RNA.  
     
     
         11 . The method of  claim 9  wherein the DNA and protein are admixed.  
     
     
         12 . The method of  claim 8  wherein the polypeptide is presented in a delayed release formulation and administered at the same time as the polynucleotide.  
     
     
         13 . The method of  claim 8  wherein the immune response is a Th1 response.  
     
     
         14 . A pharmaceutical composition comprising DNA+polypeptide, wherein the DNA encodes the polypeptide of interest and wherein the ratio of DNA:Polypeptide is from 1000:1 to 1:1 (w/w).  
     
     
         15 . The pharmaceutical composition of  claim 14  wherein the polypeptide is presented in a delayed release formulation.  
     
     
         16 . The method of  claim 15  wherein the polypeptide is coated with a biodegradable polymer comprising poly(capro-lactone) or poly(lactide-co-glycolide).  
     
     
         17 . A method to prepare a pharmaceutical formulation according to  claim 14 , which method comprises: purifying a polynucleotide encoding for a polypeptide of interest; purifying a polypeptide of interest; and admixing the combination thereof.  
     
     
         18 . A method to prepare a pharmaceutical formulation according to  claim 15 , which method comprises: purifying a polynucleotide encoding for a polypeptide of interest; purifying a polypeptide of interest; encapsulating the polypeptide of interest in a delayed release formulation; and admixing the combination thereof.  
     
     
         19 . A vaccine comprising DNA+polypeptide, wherein the DNA encodes the polypeptide of interest, and wherein the ratio of DNA:Polypeptide is from 1000:1 to 1:1 (w/w).  
     
     
         20 . The vaccine of  claim 19  wherein the polypeptide is presented in a delayed release formulation.  
     
     
         21 . The vaccine according to  claim 19  comprising DNA+polypeptide and a suitable adjuvant.  
     
     
         22 . The vaccine according to  claim 20  comprising DNA+polypeptide presented in a delayed release formulation and a suitable adjuvant.  
     
     
         23 . The use of DNA+polypeptide admixed together in the manufacture of a composition for use in enhancing the immune response of a mammal.  
     
     
         24 . The use of DNA+polypeptide wherein the polypeptide is presented in a delayed release formulation admixed together in the manufacture of a composition for use in enhancing the immune response of a mammal.