Method for Inducing a Cell-Mediated Immune Response and Improved Parenteral Vaccine Formulations Thereof

Abstract

A method of inducing either a T H 1 polarised immune response, a T H 2 polarised immune response or a combined T H 1 and T H 2 response to an antigen and associated vaccine formulations are disclosed. A method is provided for inducing a polarised T H 1 response by parenteral administration of microparticles sized such that at least 50% of the microparticles are less than 5 μm, the microparticles containing antigen entrapped or encapsulated by a biodegradable polymer. Additionally, a method is provided for inducing a polarised T H 2 response by parenteral administration of nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles containing antigen entrapped or encapsulated by a biodegradable polymer. Vaccine formulations containing the B. pertussis antigens PTd, FHA or a combination of PTd and FHA are provided.

1 .- 6 . (canceled)  
     
     
         7 . A method of inducing a T H 2 polarised immune response to an antigen, comprising parenterally administering to a subject nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles comprising the antigen entrapped or encapsulated by a biodegradable polymer.  
     
     
         8 . The method of  claim 7 , wherein the nanoparticles are sized such that at least 50% of the nanoparticles are less than 500 nm.  
     
     
         9 . The method of  claim 7 , wherein the biodegradable polymer comprises a copolymer of lactic acid and glycolic acid or enantiomers thereof.  
     
     
         10 . The method of  claim 7 , wherein the nanoparticles are formed using a coacervation method.  
     
     
         11 . The method of  claim 7 , wherein the antigen comprises a  B. pertussis  antigen.  
     
     
         12 . The method of  claim 7 , wherein the parenteral administration is selected from the group consisting of intraperitoneal administration, subcutaneous administration and intramuscular administration.  
     
     
         13 .- 20 . (canceled)  
     
     
         21 . A vaccine formulation for enhancing the T H 2 immune response to at least one antigen and adapted for parenteral administration comprising a pharmaceutically acceptable carrier and a pharmaceutically effective amount of nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles comprising the at least one antigen entrapped or encapsulated by a biodegradable polymer.  
     
     
         22 . The vaccine formulation of  claim 21 , wherein the nanoparticles are sized such that at least 50% of the nanoparticles are less than 500 nm.  
     
     
         23 . The vaccine formulation of  claim 21 , wherein the biodegradable polymer comprises a copolymer of lactic acid and glycolic acid and enantiomers thereof.  
     
     
         24 . The vaccine formulation of  claim 21 , wherein the nanoparticles are formed using a coacervation method.  
     
     
         25 . The vaccine formulation of  claim 21 , wherein the at least one antigen comprises a  B. pertussis  antigen.  
     
     
         26 . The vaccine formulation of  claim 21 , wherein the nanoparticles comprise at least 2 subpopulations of nanoparticles, each subpopulation comprising a different antigen entrapped or encapsulated by a biodegradable polymer.  
     
     
         27 .- 34 . (canceled)