Norovirus vaccine formulations

Abstract

The present invention relates to antigenic and vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to a process for the production of both monovalent and multivalent VLPs, the VLPs comprising capsid proteins from one or more Norovirus genogroups.

1 - 32 . (canceled) 
     
     
         33 . A method of generating an immune response to two or more Norovirus strains in a subject, comprising administering to a subject an antigenic formulation comprising a combination of at least two monovalent Norovirus VLPs or an antigenic formulation comprising multivalent VLPs. 
     
     
         34 . The method of claim  32 , wherein at least one of said Norovirus strains is different than the strains of said VLPs. 
     
     
         35 . The method of  claim 33 , wherein said two or more Norovirus strains are of different genotypes. 
     
     
         36 . The method of  claim 33 , wherein at least one of said Norovirus strains is different than the genotypes of said VLPs. 
     
     
         37 . The method of  claim 33 , wherein said two or more Norovirus strains are of different genogroups. 
     
     
         38 . The method of  claim 33 , wherein at least one of said Norovirus strains is different than the genogroups of said VLPs. 
     
     
         39 . The method of  claim 37 , wherein said genogroups are selected from the group consisting of GI, GII, GIII and GIV. 
     
     
         40 . The method of  claim 33 , wherein said monovalent Norovirus VLPs are derived from genogroup I or genogroup II viral sequences or a consensus viral sequence derived from two or more Norovirus strains. 
     
     
         41 . The method of  claim 37 , wherein said monovalent Norovirus VLPs are derived from genotypes I.1 and II.4. 
     
     
         42 . The method of  claim 33 , wherein the antigenic formulation is administered mucosally or parenterally. 
     
     
         43 . The method of claim  7 , wherein mucosal administration is accomplished intranasally. 
     
     
         43 . The method of  claim 42 , wherein parenteral administration is accomplished intramuscularly. 
     
     
         44 . The method of  claim 33 , wherein the antigenic formulation includes one or more adjuvants selected from the group consisting of toll-like receptor agonists and aluminum salts. 
     
     
         45 . The method of  claim 33 , wherein the antigenic formulation further comprises a delivery agent. 
     
     
         46 . A method of generating an immune response to at least one Norovirus strain in a subject, comprising administering to a subject an antigenic formulation comprising a combination of at least two monovalent norovirus VLPs or an antigenic formulation comprising multivalent VLPs, wherein the immune response to said at least one Norovirus strain is greater on average than the response obtained against said at least one Norovirus strain by administering any of the monovalent VLPs in isolation. 
     
     
         47 . The method of  claim 47 , wherein said at least one Norovirus strain is different than any of the strains used to produce said VLPs. 
     
     
         48 . The method of  claim 47 , wherein said at least one Norovirus strain is of a different genotype than any of the strains used to produce said VLPs. 
     
     
         49 . The method of  claim 47 , wherein said at least one Norovirus strain is of a different genogroup than any of the strains used to produce said VLPs.