Papilloma virus capsomere vaccine formulations and methods of use

Abstract

Vaccine formulations comprising viral capsomeres are disclosed along with methods for their production. Therapeutic and prophylactic methods of use for the vaccine formulations are also disclosed.

1 . A vaccine formulation comprising a human papilloma virus capsomere, said capsomere comprising a fusion protein comprising a human papilloma virus L1 protein adjacent amino acid residues from a second protein.  
     
     
         2 . A vaccine formulation comprising a human papilloma virus capsomere, said capsomere comprising a truncated human papilloma virus L1 protein having a deletion of one or more amino acid residues necessary for formation of a virus-like particle.  
     
     
         3 . The vaccine formulation of  claim 2  wherein said capsomere comprises a fusion protein comprising a truncated human papilloma virus L1 protein adjacent amino acid residues from a second protein.  
     
     
         4 . The vaccine formulation of any one of claims  1 ,  2 , or  3  wherein the L1 protein is encoded in the genome of a human papilloma virus selected from the group consisting of HPV6, HPV11, HPV16, HPV18, HPV33, HPV35, and HPV45.  
     
     
         5 . The vaccine formulation of  claim 4  wherein the papilloma virus is HVP16.  
     
     
         6 . The vaccine formulation of any one of claims  2 ,  3 , or  5  wherein carboxy terminal amino acid residues are deleted from the L1 protein.  
     
     
         7 . The vaccine formulation of  claim 6  wherein 1 to 34 carboxy terminal amino acid residues are deleted from the L1 protein.  
     
     
         8 . The vaccine formulation of  claim 7  wherein 34 carboxy terminal amino acid residues are deleted from the L1 protein.  
     
     
         9 . The vaccine formulation of any one of claims  2 ,  3 , or  5  wherein amino terminal amino acid residues are deleted from the L1 protein.  
     
     
         10 . The vaccine formulation of any one of claims  2 ,  3  or  5  wherein internal amino acid residues are deleted from the L1 protein.  
     
     
         11 . The vaccine formulation of  claim 10  wherein the amino acid residues deleted from the L1 protein comprise a nuclear localization signal.  
     
     
         12 . The vaccine formulation of claims  2  or  3  wherein the amino acids residues from the second protein are derived from an HPV protein.  
     
     
         13 . The vaccine formulation of  claim 12  wherein the HPV protein is an early HPV protein.  
     
     
         14 . The vaccine formulation of  claim 12  wherein the early HPV protein is selected from the group consisting of E1, E2, E3, E4, E5, E6, and E7.  
     
     
         15 . A method of treating an individual infected with an HPV virus comprising the step of administering to a patient in need thereof an amount of the vaccine formulation of claims  1 ,  2 ,  3 ,  5 ,  7 ,  8 ,  11 ,  13  or  14  effective to reduce the level of HPV infection.  
     
     
         16 . A method for preventing papilloma virus infection comprising the step of administering to an individual susceptible thereto an amount of the vaccine formulation of claims  1 ,  2 ,  3 ,  5 ,  7 ,  8 ,  11 ,  13  or  14  effective to inhibit HPV infection.