NOROVIRUS VACCINE
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.
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.