IPC분류정보
국가/구분 |
United States(US) Patent
등록
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국제특허분류(IPC7판) |
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출원번호 |
US-0790715
(2004-03-03)
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등록번호 |
US-7378097
(2008-05-27)
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발명자
/ 주소 |
- Glenn,Gregory M.
- Alving,Carl R.
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출원인 / 주소 |
- The United States of America as represented by the Secretary of the Army
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대리인 / 주소 |
Morgan, Lewis & Bockius LLP
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인용정보 |
피인용 횟수 :
2 인용 특허 :
221 |
초록
▼
A transcutaneous immunization system where the topical application of an adjuvant and an antigen or nucleic acid encoding for an antigen, to intact skin induces a systemic or mucosol antibody response. The immune response so elicited can be enhanced by physical or chemical skin penetration enhancem
A transcutaneous immunization system where the topical application of an adjuvant and an antigen or nucleic acid encoding for an antigen, to intact skin induces a systemic or mucosol antibody response. The immune response so elicited can be enhanced by physical or chemical skin penetration enhancement.
대표청구항
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What we claim is: 1. A method for inducing an antigen-specific immune response in a subject comprising: a) pretreating an area of the skin of the subject, wherein pretreating comprises applying means for enhancing penetration and/or barrier disruption of the skin; and b) applying a formulation tran
What we claim is: 1. A method for inducing an antigen-specific immune response in a subject comprising: a) pretreating an area of the skin of the subject, wherein pretreating comprises applying means for enhancing penetration and/or barrier disruption of the skin; and b) applying a formulation transcutaneously to the pretreated area to induce an antigen-specific immune response, wherein the formulation comprises: 1) an antigen in an amount effective to induce an antigen-specific immune response; 2) an adjuvant present in an amount effective to enhance the immune response to the antigen; and, 3) a pharmaceutically acceptable carrier; wherein pretreating enhances the immune response. 2. The method of claim 1, wherein pretreating comprises applying to the skin a chemical means, a physical means, a mechanical means, a hydration means, or a combination thereof. 3. The method of claim 1, wherein pretreating comprises applying a chemical to the skin. 4. The method of claim 3, wherein the chemical is an alcohol, an acetone, a detergent, a depilatory agent, a keratinolytic formulation, a cream, or a combination thereof. 5. The method of claim 1, wherein pretreating comprises applying a device. 6. The method of claim 5, wherein the device is selected from the group consisting of a propellant device, a device comprising tines, a device comprising microneedles, a device comprising a tine disk, a tape stripping device, a gas powered gun, a swab, an emery board, an abrasive pad, an electroporation device, an ultrasound device, and an iontophoresis device. 7. The method of claim 1, wherein the antigen is a nucleic acid encoding an antigen, carbohydrate, a glycolipid, a glycoprotein, a lipid, a lipoprotein, phospholipid, a polypeptide, a protein, a fusion protein, or chemical conjugate of a combination thereof. 8. The method of claim 1, wherein the antigen is derived from a pathogen. 9. The method of claim 8, wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 10. The method of claim 9, wherein the virus is an influenza virus or a rabies virus. 11. The method of claim 10, wherein the antigen is hemagglutinin A. 12. The method of claim 9, wherein the bacterium is E. coli or Bacillus anthracis. 13. The method of claim 12, wherein the antigen is E. coli heat-labile enterotoxin (LT). 14. The method of claim 12, wherein the antigen is a nucleic acid encoding E. coli heat-labile enterotoxin (LT). 15. The method of claim 1, wherein the antigen is a pathogen. 16. The method of claim 15, wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 17. The method of claim 16, wherein the virus is a whole virus, a live virus, an attenuated live virus, an inactivated virus, a detergent treated virus, or a combination thereof. 18. The method of claim 17, wherein the virus is an influenza virus or a rabies virus. 19. The method of claim 18, wherein the influenza virus comprises hemagglutinin A. 20. The method of claim 16, wherein the bacterium is E coli or Bacillus anthracis. 21. The method of claim 20, wherein the E. coli comprises E. coli heat-labile enterotoxin (LT). 22. The method of claim 1, wherein the antigen is a multivalent antigen. 23. The method of claim 1, wherein the adjuvant comprises a molecule selected from the group consisting of a bacterial ADP-ribosylating exotoxin (bARE), a binding B subunit of a bARE, a toxoid of a bARE, a genetically altered bARE, and a genetically detoxified mutant of a bARE. 24. The method of claim 23, wherein the antigen is an influenza antigen. 25. The method of claim 1, wherein the adjuvant is a nucleic acid encoding a molecule selected from the group consisting of a bacterial ADP-ribosylating exotoxin (bARE), a binding B subunit of a bARE, a toxoid of a bARE, a genetically altered bARE, and a genetically detoxified mutant of a bARE. 26. The method of claim 25, wherein the nucleic acid encodes E. coli heat labile enterotoxin (LT). 27. The method of claim 1, wherein the antigen and the adjuvant are the same molecule. 28. The method of claim 27, wherein the molecule is E. coli heat-labile enterotoxin (LT). 29. The method of claim 27, wherein the molecule is hemagglutinin A. 30. The method of 1, wherein the formulation is applied using a patch. 31. The method of claim 1, wherein the adjuvant is selected from the group consisting of nucleic acid encoding an adjuvant, bacterial exotoxin, cytokine, chemokine, lipopolysaccharide, a molecule containing unmethylated CpG motifs, a heat shock protein, a derivative of a heat shock protein, tumor necrosis factor, genetically detoxified toxin, and combinations thereof. 32. The method of claim 1, wherein the adjuvant is provided as a nucleic acid comprising a sequence encoding the adjuvant. 33. The method of claim 1, wherein the antigen or adjuvant activates an antigen presenting cell. 34. The method of claim 33, wherein the antigen presenting cell is a Langerhans cell or a dermal dendritic cell. 35. The method of claim 1, wherein the antigen is a whole microorganism, a whole cell, or a virion. 36. A method for inducing an antigen-specific immune response in a subject comprising concurrently, a) treating an area of the skin of the subject, wherein treating comprises applying means for enhancing penetration and/or barrier disruption of the skin; and b) applying a formulation transcutaneously to the treated area to induce an antigen-specific immune response, wherein the formulation comprises: 1) an antigen in an amount effective to induce an antigen-specific immune response; 2) an adjuvant present in an amount effective to enhance the immune response to the antigen; and, 3) a pharmaceutically acceptable carrier; wherein treating enhances the immune response. 37. The method of claim 36, wherein treating comprises applying to the skin a chemical means, a physical means, a mechanical means, a hydration means, or a combination thereof. 38. The method of claim 36, wherein treating comprises applying a chemical to the skin. 39. The method of claim 38, wherein the chemical is an alcohol, an acetone, a detergent, a depilatory agent, a keratinolytic formulation, a cream, or a combination thereof. 40. The method of claim 36, wherein treating comprises applying a device. 41. The method of claim 40, wherein the device is selected from the group consisting of a propellant device, a device comprising tines, a device comprising microneedles, a device comprising a tine disk, a tape stripping device, a gas powered gun, a swab, an emery board, an abrasive pad, an electroporation device, an ultrasound device, and an iontophoresis device. 42. The method of claim 36, wherein the antigen is a nucleic acid encoding an antigen, carbohydrate, a glycolipid, a glycoprotein, a lipid, a lipoprotein, phospholipid, a polypeptide, a protein, a fusion protein, or chemical conjugate of a combination thereof. 43. The method of claim 36, wherein the antigen is derived from a pathogen. 44. The method of claim 43, wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 45. The method of claim 44, wherein the virus is an influenza virus or a rabies virus. 46. The method of claim 45, wherein the antigen is hemagglutinin A. 47. The method of claim 44, wherein the bacterium is E. coli or Bacillus anthracis. 48. The method of claim 47, wherein the antigen is E. coli heat-labile enterotoxin (LT). 49. The method of claim 47, wherein the antigen is a nucleic acid encoding E. coli heat-labile enterotoxin (LT). 50. The method of claim 34, wherein the antigen is a pathogen. 51. The method of claim 50, wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 52. The method of claim 51, wherein the virus is a whole virus, a live virus, an attenuated live virus, an inactivated virus, a detergent treated virus, or a combination thereof. 53. The method of claim 52, wherein the virus is an influenza virus or a rabies virus. 54. The method of claim 53, wherein the influenza virus comprises hemagglutinin A. 55. The method of claim 51, wherein the bacterium is E coli or Bacillus anthracis. 56. The method of claim 55, wherein the E. coli comprises E. coli heat-labile enterotoxin (LT). 57. The method of claim 34, wherein the antigen is a multivalent antigen. 58. The method of claim 34, wherein the adjuvant comprises a molecule selected from the group consisting of a bacterial ADP-ribosylating exotoxin (bARE), a binding B subunit of a bARE, a toxoid of a bARE, a genetically altered bARE, and a genetically detoxified mutant of a bARE. 59. The method of claim 58, wherein the antigen is an influenza antigen. 60. The method of claim 34, wherein the adjuvant is a nucleic acid encoding a molecule selected from the group consisting of a bacterial ADP-ribosylating exotoxin (bARE), a binding B subunit of a bARE, a toxoid of a bARE, a genetically altered bARE, and a genetically detoxified mutant of a bARE. 61. The method of claim 60, wherein the nucleic acid encodes E. coli heat labile enterotoxin (LT). 62. The method of claim 36, wherein the antigen and the adjuvant are the same molecule. 63. The method of claim 62, wherein the molecule is E. coli heat-labile enterotoxin (LT). 64. The method of claim 62, wherien the molecule is hemagglutinin A. 65. The method of 36, wherein the formulation is applied using a patch. 66. The method of claim 36, wherein the adjuvant is selected from the group consisting of nucleic acid encoding an adjuvant, bacterial exotoxin, cytokine, chemokine, lipopolysaccharide, a molecule containing unmethylated CpG motifs, a heat shock protein, a derivative of a heat shock protein, tumor necrosis factor, genetically detoxified toxin, and combinations thereof. 67. The method of claim 36, wherein the adjuvant is provided as a nucleic acid comprising a sequence encoding the adjuvant. 68. The method of claim 36, wherein the antigen or adjuvant activates an antigen presenting cell. 69. The method of claim 68, wherein the antigen presenting cell is a Langerhans cell or a dermal dendritic cell. 70. The method of claim 36, wherein the antigen is a whole microorganism, a whole cell, or a virion. 71. A method for inducing an antigen-specific immune response in a subject comprising: a) delivering parenterally a first formulation comprising an antigen to a subject; b) treating an area of the skin of the subject, wherein treating comprises applying means for enhancing penetration and/or barrier disruption of the skin to enhance the immune response; and c) applying transcutaneously a second formulation comprising an adjuvant to the area of the skin, thereby inducing an antigen-specific immune response. 72. The method of claim 71, wherein treating comprises applying to the skin a chemical means, a physical means, a mechanical means, a hydration means, or a combination thereof. 73. The method of claim 71, wherein treating comprises applying a chemical to the area of the skin. 74. The method of claim 73, wherein the chemical is an acetone, a detergent, a depilatory agent, a keratinolytic formulation, or a combination thereof. 75. The method of claim 71, wherein treating comprises applying a device. 76. The method of claim 75, wherein the device is selected from the group consisting of a propellant device, a device comprising tines, a device comprising microneedles, a device comprising a tine disk, a tape stripping device, a gas powered gun, a swab, an emery board, an abrasive pad, an electroporation device, an ultrasound device, and an iontophoresis device. 77. The method of claim 71, wherein the antigen is a nucleic acid encoding an antigen, a carbohydrate, a glycolipid, a glycoprotein, a lipid, a lipoprotein, phospholipid, a polypeptide, a protein, a fusion protein, or chemical conjugate of a combination thereof. 78. The method of claim 71, wherein the antigen is derived from a pathogen. 79. The method of claim 78, wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 80. The method of claim 79, wherein the virus is an influenza virus or a rabies virus. 81. The method of claim 80, wherein the antigen is hemagglutinin A. 82. The method of claim 79, wherein the bacterium is E. coli or Bacillus anthracis. 83. The method of claim 82, wherein the antigen is E. coli heat-labile enterotoxin (LT). 84. The method of claim 81, wherein the antigen is a nucleic acid encoding E. coli heat-labile enterotoxin (LT). 85. The method of claim 71, wherein the antigen is a pathogen. 86. The method of claim 85, wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 87. The method of claim 86, wherein the virus is a whole virus, a live virus, an attenuated live virus, an inactivated virus, a detergent treated virus, or a combination thereof. 88. The method of claim 87, wherein the virus is an influenza virus or a rabies virus. 89. The method of claim 88, wherein the influenza virus comprises hemagglutinin A. 90. The method of claim 86, wherein the bacterium is E coli or Bacillus anthracis. 91. The method of claim 90, wherein the E. coli comprises E. coli heat-labile enterotoxin (LT). 92. The method of claim 71, wherein the antigen is a multivalent antigen. 93. The method of claim 71, wherein the adjuvant comprises a molecule selected from the group consisting of a bacterial ADP-ribosylating exotoxin (bARE), a binding B subunit of a bARE, a toxoid of a bARE, a genetically altered bARE, and a genetically detoxified mutant of a bARE. 94. The method of claim 93, wherein the antigen is an influenza antigen. 95. The method of claim 71, wherein the adjuvant is a nucleic acid encoding a molecule selected from the group consisting of a bacterial ADP-ribosylating exotoxin (bARE), a binding B subunit of a bARE, a toxoid of a bARE, a genetically altered bARE, and a genetically detoxified mutant of a bARE. 96. The method of claim 95, wherein the nucleic acid encodes E. coli heat labile enterotoxin (LT). 97. The method of claim 71, wherein the adjuvant is selected from the group consisting of nucleic acid encoding an adjuvant, bacterial exotoxin, cytokine, chemokine, lipopolysaccharide, a molecule containing umethylated CpG motifs, a heat shock protein, a derivative of a heat shock protein, tumor necrosis factor, genetically detoxified toxin, and combinations thereof. 98. The method of claim 71, wherein the adjuvant is provided as a nucleic acid comprising a sequence encoding the adjuvant. 99. The method of claim 71, wherein the antigen or adjuvant activates an antigen presenting cell. 100. The method of claim 99, wherein the antigen presenting cell is a Langerhans cell or a dermal dendritic cell. 101. The method of claim 71, wherein the antigen is a whole microorganism, a whole cell, or a virion. 102. The method of claim 71, wherein the first formulation is administered subcutaneously, intradermally, or intramuscularly. 103. The method of claim 71, wherein the second formulation is applied using a patch. 104. The method of claim 7, wherein the nucleic acid is a DNA encoding an influenza protein. 105. The method of claim 42, wherein the nucleic acid is a DNA encoding an influenza protein. 106. The method of claim 77, wherein the nucleic acid is a DNA encoding an influenza protein. 107. The method of claim 28, wherein the LT is a genetically altered toxin. 108. The method of claim 63, wherein the LT is a genetically altered toxin.
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