Norovirus vaccine formulations

1. An immunogenic composition comprising at least one Norovirus antigen and an effective amount of at least one adjuvant, wherein the adjuvant is a toll-like receptor (TLR) agonist that is not a bacterial exotoxin, wherein said antigen comprises Norovirus virus-like particles (VLPs), and wherein the composition is formulated as a stable dry powder, wherein the percent aggregation of VLPs in the composition remains 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 MPL.

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

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

15. The composition of claim 14 , wherein said one or more doses are unit doses.

16. The composition of claim 14 , wherein the device is a single-use nasal administration device.

17. The composition of claim 14 , wherein said composition is stored in said device.

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

19. The composition of claim 18 , wherein the mucosal route of administration is intranasal, oral, or vaginal.

20. The composition of claim 18 , 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.

21. The composition of claim 20 , wherein the composition is administered to one or both nostrils.

22. 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).

23. 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.

24. The composition of claim 23 , wherein the dosage of the Norovirus antigen is from about 1 μg to about 1 mg per dose.

25. The composition of claim 23 , wherein the dosage of the Norovirus antigen is from about 1 μg to about 500 μg per dose.

26. The composition of claim 23 , wherein the dosage of the Norovirus antigen is from about 1 μg to about 100 μg per dose.

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

28. The composition of claim 27 , wherein the genogroup II Norovirus is a GII.4 Norovirus.

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

30. The formulation of claim 29 , 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.

31. The formulation of claim 30 , wherein the route of administration is intramuscular.

32. The formulation of claim 29 , wherein the formulation is in the form of a nasal spray or nasal drops.

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

34. The composition of claim 1 , wherein the composition further comprises a sugar.

35. The composition of claim 34 , wherein said sugar is present at a concentration of between 10 and 200 mg/mL.

36. The composition of claim 1 , wherein said composition comprises Norovirus VLPs produced from genogroup I and genogroup II viral strains.

37. The composition of claim 34 , wherein said sugar is selected from the group consisting of sucrose, trehalose and lactose.

38. The composition of claim 1 , wherein the composition further comprises a mucoadhesive.

39. A composition comprising at least two Norovirus antigens, an effective amount of at least one adjuvant that is a TLR agonist that is not a bacterial exotoxin, and a mucoadhesive, wherein at least one of said Norovirus antigens comprises Norovirus virus-like particles (VLPs) produced from a genogroup I viral strain, and wherein at least one of said Norovirus antigens comprises Norovirus VLPs produced from a genogroup II viral strain, and wherein the composition is formulated as a stable dry powder.

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

41. 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.