Treatment of Infection

Abstract

The invention relates to compositions including a substance useful as an adjuvant for potentiating an immune response, and methods of using the composition in individuals with infections of tissue within or adjacent to a transformation zone, such as the transformation zone of the cervix or anal canal.

1 . A therapeutic or pharmaceutical composition including a substance useful as an adjuvant for potentiating an immune response, the substance being comprised of
 a combination of a therapeutically effective amount of aluminium hydroxide and 3′-deacylated monophospholipid A (MPL); and   a pharmaceutically acceptable diluent or carrier   
       the composition being characterised in that the composition does not include an immunogen for invoking an immune response. 
     
     
         2 . The therapeutic or pharmaceutical composition according to  claim 1 , wherein the therapeutically effective amount of aluminium hydroxide is between 0.1 to 1 mg per unit dosage, and the therapeutically effective amount of MPL is between 1 to 100 μg. 
     
     
         3 . The therapeutic or pharmaceutical composition according to  claim 1 , wherein the therapeutically effective amount of aluminium hydroxide is between 0.2 to 0.5 mg per unit dosage, and the therapeutically effective amount of MPL is between 40 to 600 μg. 
     
     
         4 . The therapeutic or pharmaceutical composition according to any one of  claims 1 - 3 , formulated for topical administration. 
     
     
         5 . The therapeutic or pharmaceutical composition according to any one of  claims 1   4  further comprising one or more of the following: sodium chloride, L-histidine, sodium borate, lactic acid, sodium phosphate monobasic, sorbitan monostearate, polysorbate 60, cetyl esters wax, benzyl alcohol, glycerol, cetostearyl alcohol, isopropyl myristate, propylene glycol, purified water, chlorohexidine hydrochloride octyldodecanol, sodium hydroxide, stearic acid and paraffin liquid. 
     
     
         6 . The therapeutic or pharmaceutical composition according to any one of  claims 1   4  further comprising sodium chloride and sodium phosphate monobasic, and one or more of L-histidine, sodium borate, lactic acid, sorbitan monostearate, polysorbate 60, cetyl esters wax, benzyl alcohol, glycerol, cetostearyl alcohol, isopropyl myristate, propylene glycol, purified water, chlorohexidine hydrochloride and paraffin liquid. 
     
     
         7 . The therapeutic or pharmaceutical composition according to any one  claims 1 - 4  further comprising sodium chloride, L-histidine, Polysorbate 60 and sodium borate, and one or more of lack acid, sodium phosphate monobasic, sorbitan monostearate, cetyl estate wax, benzyl, alcohol, glycerol, cetostearyl alcohol, isopropyl myristate, propylene glycol, purified water, chlorohexidine hydrochloride octyldodecanol sodium hydroxide, stearic acid and paraffin liquid. 
     
     
         8 . A use of a compaction according to any one of  claims 1 - 7  in the manufacture of means for treating an infection in an individual. 
     
     
         9 . A method for treating an infection in an individual including the steps of selecting an individual having an infection of tissue within or adjacent to a transformation zone; and contacting the tissue with a therapeutically effective amount of a composition including a substance useful as an adjuvant for potentiating an immune response and which is a combination of aluminium hydroxide and 3′-deacylated monophospholipid A. 
     
     
         10 . A method according to  claim 9  wherein the infection is a HPV infection. 
     
     
         11 . A method of minimising the incidence of a complication of a cervical or anal HPV infection in an individual including the step of selecting an individual having a cervical or anal HPV infection and contacting infected tissue in or adjacent to a transformation zone in the individual with a therapeutically effected amount of a composition including a substance useful as an adjuvant for potentiating an immune response and which is a combination of aluminium hydroxide and 3′-deacylated monophospholipid A. 
     
     
         12 . A method according to any one of  claims 9  to  11 , wherein the individual having an infection of tissue is selected on the basis of cellular changes in a sample from the transformation zone of the individual, physical examination or by detection of nucleic and of an agent causing the infection. 
     
     
         13 . A method according to any one of  claims 9  to  12 , wherein the transformation zone is the cervical or the anal transformation zone. 
     
     
         14 . A method according to any one of  claims 9  to  13 , wherein the infection is in the transformation zone. 
     
     
         15 . A method for treating an individual having a cervical or anal HPV infection including the step of contacting infected tissue within or adjacent to the cervical or anal transformation zone in the individual with a therapeutically effective amount of a composition including a substance useful as an adjuvant for potentiating an immune response and which is a combination of aluminium hydroxide and 3′-deacylated monophospholipid. 
     
     
         16 . A method according to  claim 10 ,  11  or  15 , wherein the individual has a co-infection of viral, bacterial, fungal or protozoan origin. 
     
     
         17 . A method according to any one of  claims 9  to  1  wherein the transformation zone is abraded or ruptured prior to contacting the infected tissue within or adjacent to the transformation zone. 
     
     
         18 . A method according to any one of  claims 9  to  17  wherein the composition is brought into contact with the infected tissue by means of an apparatus, the apparatus comprising a stem means adapted for insertion along an orifice or canal to access the transformation zone; means carried by the stem means for occluding a distal restriction; and means to deliver an effective amount of the composition to the infected tissue. 
     
     
         19 . A method according to any one of  claims 9  to  17  wherein the composition is brought into contact with the surface of the infected tissue by direct application to the surface or injection of the composition into cells at the surface of the infected tissue. 
     
     
         20 . A method according to any one of  claims 9  to  18  wherein the composition further includes an immunogen selected from one or more of a viral immunogen, a bacterial immunogen, a fungal immunogen and a protozoan immunogen. 
     
     
         21 . A topical composition including a substance useful as an adjuvant for potentiating an immune response, the substance being comprised of a combination of a therapeutically effective amount of aluminium hydroxide and 3′-deacylated monophospholipid A (MPL); and a pharmaceutically acceptable diluent or carrier, the composition being characterised in that the composition does not include an immunogen for invoking an immune response.