Patent EA-004744-B1 (EA)
Title: Adjuvant combination formulations
Inventor: HAGEN MICHAEL
IPC: A61K39/39
Filed: 2001-11-08
Abstract: 1. An antigenic composition comprising a selected antigen from a pathogenic virus, bacterium, fungus or parasite, or from a cancer cell or tumor cell, or from an allergen, or an autologous molecule, and an effective adjuvanting immuno stimulating) amount of the combination of: (1) aminoalkyl glucosamine phosphate compound (AGP), or a derivative or analog thereof, and (2) a cytokine or lymphokine, or an agonist to said cytokine or lymphokine, wherein the combination of adjuvants enhances the immune response in a vertebrate host to said antigen. 2. The antigenic composition of Claim 1 where the selected antigen is a polypeptide, peptide or fragment derived from a protein. 3. The antigenic composition of Claim 1 where the AGP is used in the form of a stable oil-in-water emulsion. 4. The antigenic composition of Claim 1 where the cytokine or lymphokine is selected from the group consisting of granulocyte macrophage colony stimulating factor and interleukin-12. 5. The antigenic composition of Claim 4 where the cytokine or lymphokine is granulocyte macrophage colony stimulating factor. 6. The antigenic composition of Claim 5 where the AGP is used in the form of a stable oil-in-water emulsion. 7. The antigenic composition of Claim 4 where the cytokine or lymphokine is interleukin-12. 8. The antigenic composition of Claim 7 where the AGP is used in the form of a stable oil-in-water emulsion. 9. The antigenic composition of Claim 1 which further comprises a diluent or carrier. 10. The antigenic composition of Claim 9 where the AGP is used in the form of a stable oil-in-water emulsion. 11. The antigenic composition of Claim 9 where the AGP is 2-[(R)-3-tetradecanoyloxy tetradecanoylamino]ethyl-2-dezixy-4-O-phosphono-3-O-[(R)-3-tetradecanoyloxy tetradecanoylamino]-beta-D-glucopyranoside (529). 12. The antigenic composition of Claim 1 where the selected antigen is from human immunodeficiency virus (HIV). 13. The antigenic composition of Claim 12 where the selected HIV antigen is an HIV protein, polypeptide, peptide or fragment derived from said protein. 14. The antigenic composition of Claim 13 where the selected antigens are the HIV peptides having the amino acid sequence: 15. The antigenic composition of Claim 14 where the HIV peptide is the peptide having the amino acid sequence: 16. The antigenic composition of Claim 14 where the HIV peptide is the peptide having the amino acid sequence: 17. The antigenic composition of Claim 14 where the HIV peptide is the peptide having the amino acid sequence: 18. The antigenic composition of Claim 14 where the HIV peptide is the peptide having the amino acid sequence: 19. The antigenic composition of Claim 14 where the HIV peptide is the peptide having the amino acid sequence 20. The antigenic composition of Claim 12 where the AGP A is used in the form of a stable oil-in-water emulsion. 21. The antigenic composition of Claim 12 where the cytokine or lymphokine is selected from the group consisting of granulocyte macrophage colony stimulating factor and interleukin-12. 22. The antigenic composition of Claim 21 where the cytokine or lymphokine is granulocyte macrophage colony stimulating factor. 23. The antigenic composition of Claim 22 where the AGP is used in the form of a stable oil-in-water emulsion. 24. The antigenic composition of Claim 21 where the cytokine or lymphokine is interleukin-12. 25. The antigenic composition of Claim 24 where the AGP is used in the form of a stable oil-in-water emulsion. 26. The antigenic composition of Claim 12 which further comprises a diluent or carrier. 27. The antigenic composition of Claim 26 where the AGP is used in the form of a stable oil-in-water emulsion. 28. The antigenic composition of Claim 12 where the AGP is 529. 29. A method for increasing the ability of an antigenic composition containing a selected antigen from a pathogenic virus, bacterium, fungus or parasite to elicit the immune response of a vertebrate host, which comprises administering to said host an antigenic composition of Claim 1. 30. A method for increasing the ability of an antigenic composition containing a selected antigen from a pathogenic virus, bacterium, fungus or parasite to elicit the immune response of a vertebrate host, which comprises administering to said host an antigenic composition of Claim 9. 31. A method for increasing the ability of an antigenic composition containing an HIV antigen to elicit the immune response of a vertebrate host, which comprises administering to said host an antigenic composition of Claim 12. 32. A method for increasing the ability of an antigenic composition containing an HIV antigen to elicit the immune response of a vertebrate host, which comprises administering to said host an antigenic composition of Claim 26. 33. The method of Claim 32 where the selected antigens are the HIV peptides having the amino acid sequence: 34. The method of Claim 33 where the HIV peptide is the peptide having the amino acid sequence: 35. The method of Claim 33 where the HIV peptide is the peptide having the amino acid sequence: 36. The method of Claim 33 where the HIV peptide is the peptide having the amino acid sequence: 37. The method of Claim 33 where the HIV peptide is the peptide having the amino acid sequence: 38. The method of Claim 33 where the HIV peptide is the peptide having the amino acid sequence 39. A method for increasing the ability of an antigenic composition containing a selected antigen from a pathogenic virus, bacterium, fungus or parasite to elicit cytotoxic T lymphocytes in a vertebrate host, which comprises administering to said host an antigenic composition of Claim 1. 40. A method for increasing the ability of an antigenic composition containing a selected antigen from a pathogenic virus, bacterium, fungus or parasite to elicit cytotoxic T lymphocytes in a vertebrate host, which comprises administering to said host an antigenic composition of Claim 9. 41. A method for increasing the ability of an antigenic composition containing an HIV antigen to elicit cytotoxic T lymphocytes in a vertebrate host, which comprises administering to said host an antigenic composition of Claim 12. 42. A method for increasing the ability of an antigenic composition containing an HIV antigen to elicit cytotoxic T lymphocytes in a vertebrate host, which comprises administering to said host an antigenic composition of Claim 26. 43. The method of Claim 42 where the selected antigens are the HIV peptides having the amino acid sequence: 44. The method of Claim 43 where the HIV peptide is the peptide having the amino acid sequence: 45. The method of Claim 43 where the HIV peptide is the peptide having the amino acid sequence: 46. The method of Claim 43 where the HIV peptide is the peptide having the amino acid sequence: 47. The method of Claim 43 where the HIV peptide is the peptide having the amino acid sequence: 48. The method of Claim 43 where the HIV peptide is the peptide having the amino acid sequence 49. A method for increasing the ability of an antigenic composition containing a cancer antigen or associated tumor antigen from a cancer cell or tumor cell to elicit a therapeutic or prophylactic anti-cancer effect in a vertebrate host, which comprises administering to said host an antigenic composition comprising said selected cancer antigen or tumor-associated antigen from a cancer cell or tumor cell, and an effective adjuvanting (immuno stimulating) amount of the combination of: (1) an AGP or a derivative and analog thereof, and (2) a cytokine or lymphokine, or an agonist to said cytokine or lymphokine. 50. A method for increasing the ability of an antigenic composition containing a selected allergen to moderate an allergic response in a vertebrate host, which comprises administering to said host an antigenic composition comprising said allergen, and an effective adjuvanting (immuno stimulating) amount of the combination of: (1) an AGP or a derivative and analog thereof, and (2) a cytokine or lymphokine, or an agonist to said cytokine or lymphokine. 51. An method for increasing the ability of an antigenic composition containing a selected antigen from a molecule or portion thereof which represents those produced by a host in an undesired manner, amount or location so as to reduce such an undesired effect, by including an effective adjuvanting amount of the combination of: (1) an AGP, or a derivative or analog thereof, and (2) a cytokine or lymphokine, or an agonist to said cytokine or lymphokine. 52. An antigenetic composition where selected antigen is a polypeptide, peptide or fragment derived from amyloid precursor protein, or an antibody thereto. 53. The antigenetic composition of Claim 52 where the selected antigen is the Abeta peptide, which is an internal 39-43 amino acid fragment of amyloid precursor protein, or a fragment of the Abeta peptide. 54. The antigenetic composition of Claim 53 where the selected antigen is the Abeta peptide having the amino acid sequence: Asp Ala Glu Phe Arg His Asp Ser Gly Tyr Glu Val His His Gln Lys Leu Val Phe Phe Ala Glu Asp Val Gly Ser Asn Lys Gly Ala Ile Ile Gly Leu Met Val Gly Gly Val Val Ile Ala (SEQ ID NO:6). 55. The method of Claim 59 where the AGP is 529. 56. A method for increasing the ability of an antigenic composition containing a selected antigen from a molecule or portion thereof which represents those produced by a host in an undesired manner, amount or location so as to reduce such an undesired effect, by including an effective adjuvanting amount of the combination of: (1) an AGP, or a derivative or analog thereof, and (2) a cytokine or lymphokine, or an agonist to said cytokine or lymphokine. 57. A method for increasing the ability of an antigenic composition to prevent or treat disease characterized by amyloid deposition in a vertebrate host, which comprises administering to said host a polypeptide, peptide or fragment derived from amyloid peptide protein, or an antibody thereto, and an eff