Norovirus vaccine formulations

1. An immunogenic composition comprising at least one Norovirus antigen, chitosan, sucrose, and at least one adjuvant, wherein said antigen comprises Norovirus virus-like particles (VLPs) and the adjuvant is not a bacterial exotoxin, and wherein the composition is formulated as a stable dry powder such that the percent aggregation of VLPs remains relatively constant or decreases when measured over a twelve month period.

2. The composition of claim 1 , wherein said Norovirus antigen is selected from the group consisting of Norovirus genogroup I and genogroup II viral strains.

3. The composition of claim 1 , wherein said Norovirus VLPs comprise a capsid protein.

4. The composition of claim 3 , wherein said capsid protein is VP1 and/or VP2.

5. The composition of claim 1 , wherein the VLPs are monovalent VLPs.

6. The composition of claim 1 , wherein the VLPs are multivalent VLPs.

7. The composition of claim 6 , wherein the multivalent VLPs are selected from the group consisting of genogroup I and genogroup II Noroviruses.

8. The composition of claim 1 , wherein the Norovirus VLPs are produced in a recombinant cellular expression system or a baculovirus-infected cellular expression system.

9. The composition of claim 8 , wherein the cellular expression system is selected from the group consisting of yeast, bacterial, insect, and mammalian expression system.

10. The composition of claim 1 , further comprising a second Norovirus antigen.

11. The composition of claim 10 , wherein said first and second Norovirus antigens are monovalent VLPs from different genogroups.

12. The composition of claim 1 , wherein the adjuvant is selected from the group consisting of toll-like receptor (TLR) agonists, monophosphoryl lipid A (MPL), synthetic lipid A, lipid A mimetics or analogs, aluminum salts, cytokines, saponins, muramyl dipeptide (MDP) derivatives, CpG oligos, lipopolysaccharide (LPS) of gram-negative bacteria, polyphosphazenes, emulsions, virosomes, cochleates, poly(lactide-co-glycolides) (PLG) microparticles, poloxamer particles, microparticles, and liposomes.

13. The composition of claim 12 , wherein the adjuvant is a toll-like receptor (TLR) agonist.

14. The composition of claim 12 , wherein the adjuvant is MPL.

15. The composition of claim 1 , wherein the composition has an average particle size from about 10 to 500 micrometers in diameter.

16. The composition of claim 1 in combination with one or more devices for administering one or more doses of said composition.

17. The composition of claim 16 , wherein said one or more doses are unit doses.

18. The composition of claim 16 , wherein the device is a single-use nasal administration device.

19. The composition of claim 16 , wherein said composition is stored in said device.

20. The composition of claim 1 , wherein said composition is administered to a subject by a mucosal route.

21. The composition of claim 20 , wherein the mucosal route of administration is intranasal, oral, or vaginal.

22. The composition of claim 20 , wherein the composition is administered to the nasal mucosa by rapid deposition within the nasal passage from a device of the formulation held close or inserted into the nasal passageway.

23. The composition of claim 22 , wherein the composition is administered to one or both nostrils.

24. The composition of claim 1 , wherein the Norovirus antigen is present in a concentration of from about 0.01% (w/w) to about 80% (w/w).

25. The composition of claim 1 , wherein the dosage of the Norovirus antigen is present in an amount of from about 1 μg to about 100 mg per dose.

26. The composition of claim 25 , wherein the dosage of the Norovirus antigen is from about 1 μg to about 1 mg per dose.

27. The composition of claim 25 , wherein the dosage of the Norovirus antigen is from about 1 μg to about 500 μg per dose.

28. The composition of claim 25 , wherein the dosage of the Norovirus antigen is from about 1 μg to about 100 μg per dose.

29. A method of generating antibodies to Norovirus antigens, comprising administering to a subject the composition of claim 1 .

30. A method of inducing an immune response in a subject experiencing a Norovirus infection, comprising administering to the subject the composition of claim 1 , wherein said immune response is therapeutic.

31. The composition of claim 5 , wherein the monovalent VLPs comprise at least one capsid protein from a genogroup II Norovirus.

32. The composition of claim 31 , wherein the genogroup II Norovirus is a GII.4 Norovirus.

33. The composition of claim 1 , wherein the composition is reconstituted with diluent to form a liquid formulation.

34. The formulation of claim 33 , wherein said formulation is designed to be administered to a subject by a route selected from the group consisting of mucosal, intranasal, sublingual, oral, rectal, vaginal, intramuscular, intravenous, subcutaneous, intradermal, subdermal, and transdermal routes of administration.

35. The formulation of claim 34 , wherein the route of administration is intramuscular.

36. The formulation of claim 33 , wherein the formulation is in the form of a nasal spray or nasal drops.

37. The composition of claim 1 , wherein said composition elicits a Norovirus-specific immune response when administered to a mammal.