Nucleic acid compositions for stimulating immune responses

1. A composition comprising

an immunostimulatory nucleic acid molecule comprising the nucleotide sequence of SEQ ID NO:1, wherein the immunostimulatory nucleic acid has a nucleotide backbone comprising at least one phosphorothioate modification, and wherein the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

2. The composition of claim 1 , wherein the immunostimulatory nucleic acid molecule consists of the nucleotide sequence of SEQ ID NO:1.

3. The composition of claim 1 , further comprising an antigen.

4. The composition of claim 3 , wherein the antigen is selected from the group consisting of a microbial antigen, a cancer antigen, and an allergen.

5. The composition of claim 4 , wherein the microbial antigen is selected from the group consisting of a bacterial antigen, a viral antigen, a fungal antigen and a parasitic antigen.

6. The composition of claim 3 , wherein the antigen is encoded by a nucleic acid vector.

7. The composition of claim 3 , wherein the nucleic acid vector is separate from the immunostimulatory nucleic acid.

8. The composition of claim 3 , wherein the antigen is a peptide antigen.

9. The composition of claim 1 , further comprising an adjuvant.

10. The composition of claim 9 , wherein the adjuvant is a mucosal adjuvant.

11. The composition of claim 1 , further comprising a cytokine.

12. The composition of claim 1 , further comprising a therapeutic agent selected from the group consisting of an anti-microbial agent, an anti-cancer agent and an allergy/asthma medicament.

13. The composition of claim 12 , wherein the anti-microbial agent is selected from the group consisting of an anti-bacterial agent, an anti-viral agent, an anti-fungal agent, and an anti-parasite agent.

14. The composition of claim 12 , wherein the anti-cancer agent is selected from the group consisting of a chemotherapeutic agent, a cancer vaccine, and an immunotherapeutic agent.

15. The composition of claim 12 , wherein the allergy/asthma medicament is selected from the group consisting of PDE-4 inhibitor, bronchodilator/beta-2 agonist, K+ channel opener, VLA-4 antagonist, neurokin antagonist, TXA2 synthesis inhibitor, xanthanine, arachidonic acid antagonist, 5 lipoxygenase inhibitor, thromboxin A2 receptor antagonist, thromboxane A2 antagonist, inhibitor of 5-lipox activation protein, and protease inhibitor.

16. The composition of claim 1 , wherein the nucleotide backbone is chimeric.

17. The composition of claim 1 , wherein the nucleotide backbone is entirely modified.

18. The composition of claim 1 , further comprising a pharmaceutically acceptable carrier.

19. The composition of claim 1 , wherein the immunostimulatory nucleic acid is free of methylated CpG dinucleotides.

20. The composition of claim 1 , wherein the immunostimulatory nucleic acid includes more than four CpG motifs.

21. The composition of claim 1 , wherein the immunostimulatory nucleic acid is T-rich.

22. The composition of claim 1 , wherein the immunostimulatory nucleic acid includes a poly-T sequence.

23. The composition of claim 1 , wherein the immunostimulatory nucleic acid includes a poly-G sequence.

24. The composition of claim 1 , wherein the immunostimulatory nucleic acid is formulated for oral administration.

25. The composition of claim 1 , wherein the immunostimulatory nucleic acid is formulated as a nutritional supplement.

26. The composition of claim 25 , wherein the nutritional supplement is formulated as a capsule, a pill, or a sublingual tablet.

27. The composition of claim 1 , wherein the immunostimulatory nucleic acid is formulated for local administration.

28. The composition of claim 1 , wherein the immunostimulatory nucleic acid is formulated for parenteral administration.

29. The composition of claim 1 , wherein the immunostimulatory nucleic acid is formulated in a sustained release device.

30. The composition of claim 1 , wherein the immunostimulatory nucleic acid is formulated for delivery to a mucosal surface.

31. The composition of claim 1 , wherein the mucosal surface is selected from the group consisting of an oral, nasal, rectal, vaginal, and ocular surface.

32. The composition of claim 1 , wherein the immunostimulatory nucleic acid stimulates a mucosal immune response.

33. The composition of claim 1 , wherein the immunostimulatory nucleic acid stimulates a systemic immune response.

34. The composition of claim 1 , wherein the immunostimulatory nucleic acid is provided in an amount effective to stimulate a mucosal immune response.

35. The composition of claim 1 , wherein the immunostimulatory nucleic acid is provided in an amount effective to stimulate a systemic immune response.

36. The composition of claim 1 , wherein the immunostimulatory nucleic acid is provided in an amount effective to stimulate an immune response.

37. The composition of claim 1 , wherein the immunostimulatory nucleic acid is provided in an amount effective to stimulate an immune response against an infectious agent.

38. The composition of claim 1 , wherein the immunostimulatory nucleic acid is provided in an amount effective to stimulate an immune response against an allergen.

39. The composition of claim 1 , wherein the immunostimulatory nucleic acid is provided in an amount effective to stimulate an immune response against a cancer.

40. The composition of claim 29 , wherein the sustained release device is a microparticle.

41. The composition of claim 37 , wherein the infectious agent is a herpes simplex virus.

42. A method for stimulating an immune response in a subject in need thereof comprising administering to a subject a composition comprising an immunostimulatory nucleic acid molecule comprising the nucleotide sequence of SEQ ID NO:1, in an amount effective to stimulate an immune response, wherein in the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

43. A method for inducing an innate immune response, comprising administering to the subject a composition comprising an immunostimulatory nucleic acid comprising the nucleotide sequence of SEQ ID NO:1, in an amount effective for activating an innate immune response, wherein the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

44. A composition comprising an immunostimulatory nucleic acid comprising the nucleotide sequence of SEQ ID NO:1, wherein the immunostimulatory nucleic acid is 21-100 nucleotides in length, and wherein the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

45. A composition comprising an immunostimulatory nucleic acid comprising the nucleotide sequence of SEQ ID NO:1 and an antigen, wherein the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

46. A composition comprising an immunostimulatory nucleic acid comprising the nucleotide sequence of SEQ ID NO:1, wherein the immunostimulatory nucleic acid is single stranded and wherein the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

47. A composition comprising an immunostimulatory nucleic acid consisting of the nucleotide sequence of SEQ ID NO:1, wherein the immunostimulatory nucleic acid comprises a CpG motif which is unmethylated.

48. The method of claim 42 , wherein the immunostimulatory nucleic acid is 21-100 nucleotides in length.

49. The method of claim 42 , wherein the immunostimulatory nucleic acid consists of the nucleotide sequence of SEQ ID NO:1.

50. The method of claim 42 , wherein the composition comprises an antigen.