Norovirus vaccine

Abstract

A dry powder Norovirus vaccine is provided, which comprises at least two Norovirus antigens representing different genogroups. The vaccine may be produced by formulation with a mixture of different antigens or combination of monovalent powders with each containing one antigen. The formulated vaccine is suitable for mucosal administration and soluble in aqueous solutions for parenteral administration. A method of immunization is also provided, which comprises at least one administration of the vaccine via mucosal and/or parental route. The immunization may have multiple administrations of the vaccine, i.e., one or more immunizations via a mucosal route followed by one or more immunizations via a parenteral route or vice versa, to maximize both mucosal and systemic immune responses and protection against Norovirus infections.

We claim: 
     
         1 . A method for producing a multivalent dry powder  Norovirus  vaccine composition suitable for both parenteral and mucosal routes of administration comprising:
 a. obtaining a first solution comprising a  Norovirus  virus-like particle (VLP) antigen of genogroup GI;   b. introducing to the first solution, an anionic polysaccharide;   c. drying the first solution with the anionic polysaccharide to a substantially non-aqueous state, thereby producing a first dry powder formulation;   d. obtaining a second solution comprising a  Norovirus  VLP antigen of genogroup GII;   e. introducing to the second solution an anionic polysaccharide;   f. drying the second solution with the anionic polysaccharide to a substantially non-aqueous state, thereby producing a second dry powder formulation;   g. combining the first and second dry powder formulations to form a multivalent dry powder  Norovirus  vaccine formulation.   
     
     
         2 . The method of  claim 1 , wherein the drying is by lyophilization. 
     
     
         3 . The method of  claim 1 , wherein the drying is by spray drying. 
     
     
         4 . The method of  claim 1 , wherein the  Norovirus  VLP of genogroup GI and  Norovirus  VLP of genogroup GII are obtained by expressing the recombinant virus-like particles in an expression system selected from the group consisting of: prokaryote cells, eukaryote cells,  E. coli  cells,  S. cerevisiae  cells, insect cells, mammalian cells, HEK293 cells, CHO cells, tobacco mosaic virus, and baculovirus.