Respiratory syncytial virus (rsv) polyanhydride nanoparticle vaccine

Abstract

Disclosed are compositions and methods for vaccinating susceptible individuals against infection by respiratory syncytial virus (RSV). The disclosed compositions include vaccine compositions comprising an effective amount of respiratory syncytial virus (RSV) F protein in a pre-fusion stabilized form and/or M protein incorporated into biodegradable polyanhydride polymer particles for inducing an immune response against RSV. The vaccine compositions also may include a suitable adjuvant.

We claim: 
     
         1 . A vaccine composition comprising an effective amount of respiratory syncytial virus (RSV) F protein in a pre-fusion stabilized form and/or M protein incorporated into biodegradable polyanhydride polymer particles for inducing an immune response against RSV. 
     
     
         2 . The vaccine composition of  claim 1 , comprising an effective amount of RSV F protein in the pre-fusion stabilized form incorporated into the biodegradable polyanhydride polymer particles for inducing an immune response against RSV. 
     
     
         3 . The vaccine composition of  claim 1 , wherein the F protein in a pre-fusion stabilized form is selected from the group consisting of DS-Cav1, DS-TriC, Vav-1-TriC, DX-Cav1-TriC, Pre-F-GCN4t, SC-DM, and SC-TM. 
     
     
         4 . The vaccine composition of  claim 1 , wherein the F protein in a pre-fusion stabilized form is DS-Cav1. 
     
     
         5 . The vaccine composition of  claim 1 , comprising an effective amount of RSV M protein incorporated into the biodegradable polyanhydride polymer particles for inducing an immune response against RSV. 
     
     
         6 . The vaccine composition of  claim 1 , further comprising an adjuvant. 
     
     
         7 . The vaccine composition of  claim 6 , wherein the adjuvant is incorporated into the biodegradable polyanhydride polymer particles. 
     
     
         8 . The vaccine composition of  claim 1 , further comprising a CpG oligonucleotide. 
     
     
         9 . The vaccine composition of  claim 8 , wherein the CpG oligonucleotide is incorporated into the biodegradable polyanhydride polymer particles. 
     
     
         10 . The vaccine composition of  claim 8 , wherein the CpG oligonucleotide is a CpG oligodeoxynucleotide (ODN). 
     
     
         11 . The vaccine composition of  claim 10 , wherein the CpG oligonucleotide is incorporated into the biodegradable polyanhydride polymer particles. 
     
     
         12 . The vaccine composition of  claim 1 , wherein the biodegradable polyanhydride polymer particles have an average effective diameter of less than about 5 μM. 
     
     
         13 . The vaccine composition of  claim 1 , wherein the vaccine composition induces an antibody response as well as a CD4 T cell response when administered to a subject in need thereof. 
     
     
         14 . The vaccine composition of  claim 1 , wherein the biodegradable polyanhydride polymer particles comprise a polymer formed from a 1,ω-bis(p-carboxyphenoxy)(C 2 -C 12 )alkane, a 1,ω-bis(p-carboxyphenoxy)(C 2 -C 12 )dioxa-alkane, and a (C 5 -C 20 )alkanoic diacid. 
     
     
         15 . The vaccine composition of  claim 1 , wherein the biodegradable polyanhydride polymer particles comprise a polymer formed from 1,6-bis(p-carboxyphenoxy)hexane (CPH), 1,8-bis(p-carboxyphenoxy)-3,6-dioxaoctance (CPTEG), and sebacic acid (SA). 
     
     
         16 . The vaccine composition of  claim 1 , wherein the biodegradable polyanhydride polymer particles comprise a polymer formed from 1,6-bis(p-carboxyphenoxy)hexane (CPH), 1,8-bis(p-carboxyphenoxy)-3,6-dioxaoctance (CPTEG), and sebacic acid (SA), wherein the polymer is formed from CPH and CPTEG at a ratio range of CPH:CPTEG of 80-60:20-40. 
     
     
         17 . The vaccine composition of  claim 1 , further comprising an RSV protein selected from NS1, NS2, N, P, SH, G, M2-1, M2-2, L, or any combinations thereof. 
     
     
         18 . A method comprising administering the vaccine of  claim 1  to a subject who is at risk for infection by RSV. 
     
     
         19 . The method of  claim 18 , wherein after the vaccine composition is administered to the subject, the subject is protected against infection by RSV. 
     
     
         20 . The method of  claim 18 , wherein the vaccine composition is administered by a route selected from intranasal, pulmonary, oral, subcutaneous, intramuscular, or intravenous.