US2008233142A1PendingUtilityA1

Use of penetration enhancers and barrier disruption methods to enhance the immune response of an antigen

Assignee: US GOV SEC ARMYPriority: Nov 14, 1996Filed: May 24, 2007Published: Sep 25, 2008
Est. expiryNov 14, 2016(expired)· nominal 20-yr term from priority
A61K 39/00A61K 9/0014A61K 31/739A61K 39/107Y02A50/30A61K 39/12C12N 2760/16034A61K 2039/54A61K 39/05C12N 2740/16234A61K 2039/55505A61K 39/39A61K 2039/55522A61K 39/102A61K 9/06A61K 2039/55533A61K 9/127A61K 39/205A61K 2039/70C12N 2760/20134A61K 2039/55561A61K 2039/55566A61K 2039/55544A61K 47/12A61K 9/107A61K 39/0258A61K 47/08A61K 2039/55572A61K 9/08A61K 39/145A61K 35/74A61K 9/7023A61K 2039/55511A61K 2039/53A61K 47/10A61K 39/008
69
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
1 - 59 . (canceled) 
     
     
         60 : 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) a pharmaceutically acceptable carrier; 
   
       wherein pretreating enhances the immune response. 
     
     
         61 : The method of  claim 60 , wherein pretreating comprises applying to the skin a chemical means, a physical means, a mechanical means, a hydration means, or a combination thereof. 
     
     
         62 : The method of  claim 60 , wherein pretreating comprises applying a chemical to the skin. 
     
     
         63 : The method of  claim 62 , wherein the chemical is an alcohol, an acetone, a detergent, a depilatory agent, a keratinolytic formulation, a cream, or a combination thereof. 
     
     
         64 : The method of  claim 60 , wherein pretreating comprises applying a device. 
     
     
         65 : The method of  claim 64 , 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. 
     
     
         66 . (canceled) 
     
     
         67 : The method of  claim 60 , wherein the antigen is a nucleic acid encoding an antigen, carbohydrate, a glycolipid, a glycoprotein, a lipid, a lipoprotein, a phospholipid, a polypeptide, a protein, a fusion protein, or chemical conjugate of a combination thereof. 
     
     
         68 : The method of  claim 60 , wherein the antigen is derived from a pathogen. 
     
     
         69 : The method of  claim 68 , wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 
     
     
         70 : The method of  claim 69 , wherein the virus is an influenza virus or a rabies virus. 
     
     
         71 : The method of  claim 70 , wherein the antigen is hemagglutinin A. 
     
     
         72 : The method of  claim 69 , wherein the bacterium is  E. coli  or  Bacillus anthracis.    
     
     
         73 : The method of  claim 72 , wherein the antigen is  E. coli  heat-labile enterotoxin (LT). 
     
     
         74 : The method of  claim 72 , wherein the antigen is a nucleic acid encoding  E. coli  heat-labile enterotoxin (LT). 
     
     
         75 : The method of  claim 60 , wherein the antigen is a pathogen. 
     
     
         76 : The method of  claim 75 , wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 
     
     
         77 : The method of  claim 76 , 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. 
     
     
         78 : The method of  claim 77 , wherein the virus is an influenza virus or a rabies virus. 
     
     
         79 : The method of  claim 78 , wherein the influenza virus comprises hemagglutinin A. 
     
     
         80 : The method of  claim 76 , wherein the bacterium is  E coli  or  Bacillus anthracis.    
     
     
         81 : The method of  claim 80 , wherein the  E. coli  comprises  E. coli  heat-labile enterotoxin (LT). 
     
     
         82 : The method of  claim 60 , wherein the antigen is a multivalent antigen. 
     
     
         83 : The method of  claim 60 , wherein the antigen activates an antigen presenting cell. 
     
     
         84 : The method of  claim 83 , wherein the antigen presenting cell is a Langerhans cell or a dermal dendritic cell. 
     
     
         85 : The method of  claim 60 , wherein the antigen is a whole microorganism, a whole cell, or a virion. 
     
     
         86 : The method of  claim 60 , wherein the formulation is applied using a patch. 
     
     
         87 : 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) a pharmaceutically acceptable carrier; 
   
       wherein treating enhances the immune response. 
     
     
         88 : The method of  claim 87 , wherein treating comprises applying to the skin a chemical means, a physical means, a mechanical means, a hydration means, or a combination thereof. 
     
     
         89 : The method of  claim 87 , wherein treating comprises applying a chemical to the skin. 
     
     
         90 : The method of  claim 89 , wherein the chemical is an alcohol, an acetone, a detergent, a depilatory agent, a keratinolytic formulation, a cream, or a combination thereof. 
     
     
         91 : The method of  claim 87 , wherein treating comprises applying a device. 
     
     
         92 : The method of  claim 91 , 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. 
     
     
         93 . (canceled) 
     
     
         94 : The method of  claim 87 , wherein the antigen is a nucleic acid encoding an antigen, carbohydrate, a glycolipid, a glycoprotein, a lipid, a lipoprotein, a phospholipid, a polypeptide, a protein, a fusion protein, or chemical conjugate of a combination thereof. 
     
     
         95 : The method of  claim 87 , wherein the antigen is derived from a pathogen. 
     
     
         96 : The method of  claim 95 , wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 
     
     
         97 : The method of  claim 96 , wherein the virus is an influenza virus or a rabies virus. 
     
     
         98 : The method of  claim 97 , wherein the antigen is hemagglutinin A. 
     
     
         99 : The method of  claim 96 , wherein the bacterium is  E. coli  or  Bacillus anthracis.    
     
     
         100 : The method of  claim 99 , wherein the antigen is  E. coli  heat-labile enterotoxin (LT). 
     
     
         101 : The method of  claim 99 , wherein the antigen is a nucleic acid encoding  E. coli  heat-labile enterotoxin (LT). 
     
     
         102 : The method of  claim 97 , wherein the antigen is a pathogen. 
     
     
         103 : The method of  claim 102 , wherein the pathogen is a virus, a bacterium, a parasite, or a fungus. 
     
     
         104 : The method of  claim 103 , 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. 
     
     
         105 : The method of  claim 104 , wherein the virus is an influenza virus or a rabies virus. 
     
     
         106 : The method of  claim 105 , wherein the influenza virus comprises hemagglutinin A. 
     
     
         107 : The method of  claim 103 , wherein the bacterium is  E coli  or  Bacillus anthracis.    
     
     
         108 : The method of  claim 107 , wherein the  E. coli  comprises  E. coli  heat-labile enterotoxin (LT). 
     
     
         109 : The method of  claim 87 , wherein the antigen is a multivalent antigen. 
     
     
         110 : The method of  claim 87 , wherein the antigen activates an antigen presenting cell. 
     
     
         111 : The method of  claim 110 , wherein the antigen presenting cell is a Langerhans cell or a dermal dendritic cell. 
     
     
         112 : The method of  claim 87 , wherein the antigen is a whole microorganism, a whole cell, or a virion. 
     
     
         113 : The method of  claim 87 , wherein the formulation is applied using a patch. 
     
     
         114 : The method of  claim 67 , wherein the nucleic acid is a DNA encoding an influenza protein. 
     
     
         115 : The method of  claim 94 , wherein the nucleic acid is a DNA encoding an influenza protein. 
     
     
         116 : The method of  claim 73 , wherein the LT is a genetically altered toxin. 
     
     
         117 : The method of  claim 74 , wherein the LT is a genetically altered toxin. 
     
     
         118 : The method of  claim 81 , wherein the LT is a genetically altered toxin. 
     
     
         119 : The method of  claim 100 , wherein the LT is a genetically altered toxin. 
     
     
         120 : The method of  claim 101 , wherein the LT is a genetically altered toxin. 
     
     
         121 : The method of  claim 108 , wherein the LT is a genetically altered toxin.

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