US2023330202A1PendingUtilityA1

Nanoemulsion and methods of use thereof

67
Assignee: WASHINGTON UNIVERSITY ST LOUISPriority: Jun 19, 2017Filed: May 8, 2023Published: Oct 19, 2023
Est. expiryJun 19, 2037(~10.9 yrs left)· nominal 20-yr term from priority
Inventors:Shabaana Abdul KhaderMushtaq AhmedAli FattomDouglas H. SmithTarek Hamouda
A61K 40/42A61K 40/24A61K 40/19A61K 39/04G01N 33/505A61K 2039/5154A61K 2039/522A61K 2039/541A61K 2039/543A61K 2039/545A61K 2039/55561A61K 2039/55566
67
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Claims

Abstract

The present disclosure relates to compositions and methods for inducing an immune response to a composition of the invention in a subject. Additionally, the present disclosure generally relates to methods for screening for immune response to a composition of the invention.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A composition of the invention comprising:
 (a) an nanoemulsion, or a dilution thereof, wherein the nanoemulsion comprises:
 (i) an aqueous phase; 
 (ii) about 1% to about 80% (v/v) of at least one oil; 
 (iii) about 0.001% to about 10% (v/v) of at least one surfactant; 
 (iv) about 0.01% to about 50% (v/v) of at least one solvent; and 
 (v) less than about 5% (v/v) of at least one quaternary ammonium compound and; 
   (b) at least one isolated mycobacterial antigen, or an antigenic fragment thereof;   wherein the nanoemulsion consists of droplets with an average diameter of less than about 1,000 nm.   
     
     
         2 . The composition of  claim 1 , wherein the at least one isolated mycobacterial antigen, or an antigenic fragment thereof is selected from  Mycobacterium tuberculosis.    
     
     
         3 . The composition of  claim 1 , wherein the at least one isolated antigen, or an antigenic fragment thereof is selected from the group consisting of ESAT-6, CFP10, Hsp16.3, MTB32A, MTB39A, Ag85A, Ag85B, Ag85C, Rv1733c, Rv2626c, Rv3407, Rv2628, RpfB, RpfD, RpfE, and combinations thereof. 
     
     
         4 . The composition of  claim 1 , wherein the aqueous phase is selected from the group consisting of distilled water, purified water, water for injection, de-ionized water, tap water, and a phosphate buffered saline. 
     
     
         5 . The composition of  claim 1 , wherein the at least one oil is selected from the group consisting of soybean, avocado, squalene, olive, canola, corn, rapeseed, safflower, sunflower, fish and other plant oil. 
     
     
         6 . The composition of  claim 1 , wherein the at least one surfactant is selected from the group consisting of polysorbate 80 and polysorbate 20. 
     
     
         7 . The composition of  claim 1 , wherein the at least one solvent is an alcohol. 
     
     
         8 . The composition of  claim 1 , wherein the at least one quaternary ammonium compound is cetylpyridinum chloride (CPC). 
     
     
         9 . The composition of  claim 1 , wherein the isolated antigen, or an antigenic fragment thereof is present in an amount of from about 10 μg to about 50 μg. 
     
     
         10 . The composition of  claim 1 , wherein the isolated antigen, or an antigenic fragment thereof is present in an amount of about 25 μg. 
     
     
         11 . The composition of  claim 1 , wherein the isolated antigen, or an antigenic fragment thereof is ESAT-6 or Ag85B. 
     
     
         12 . The composition of  claim 1 , wherein the nanoemulsion droplets have an average diameter of less than 700 nm. 
     
     
         13 . The composition of  claim 1 , wherein the nanoemulsion droplets have an average diameter of about 400 nm. 
     
     
         14 . A method of inducing an immune response in a subject, the method comprising administering to the subject a composition of the invention comprising:
 (a) a nanoemulsion comprising:
 (i) droplets having an average diameter of less than about 1,000 nm; 
 (ii) an aqueous phase; 
 (iii) about 1% to about 80% (v/v) of at least one oil; 
 (iv) about 0.001% to about 10% (v/v) of at least one surfactant; 
 (v) about 0.01% to about 50% (v/v) of at least one solvent; 
 (vi) less than about 5% (v/v) of at least one quaternary ammonium compound; and 
   (b) at least one isolated mycobacterial antigen, or an antigenic fragment thereof.   
     
     
         15 . The method of  claim 14 , wherein the at least one isolated mycobacterial antigen, or an antigenic fragment thereof is selected from  Mycobacterium tuberculosis.    
     
     
         16 . The method of  claim 14 , wherein the at least one isolated antigen is selected from the group consisting of ESAT-6, CFP10, Ag85B, Hsp16.3, MTB32A, MTB39A, RV2660c, Ag85A, Ag85B, Ag85C, Rv1733cΔ/Rv2626c/rpfD ETC, and combinations thereof. 
     
     
         17 . The method of  claim 14 , wherein the at least one oil is selected from the group consisting of soybean, avocado, squalene, olive, canola, corn, rapeseed, safflower, sunflower, fish and other plant oil. 
     
     
         18 . The method of  claim 14 , wherein the at least one surfactant is selected from the group consisting of polysorbate 80 and polysorbate 20. 
     
     
         19 . The method of  claim 14 , wherein the at least one solvent is an alcohol. 
     
     
         20 . The method of  claim 14 , wherein the at least one quaternary ammonium compound is cetylpyridinum chloride (CPC). 
     
     
         21 . The method of  claim 14 , wherein the isolated antigen, or an antigenic fragment thereof is present in an amount of from about 10 μg to about 50 μg. 
     
     
         22 . The method of  claim 14 , wherein the isolated antigen, or an antigenic fragment thereof is present in an amount of about 25 μg. 
     
     
         23 . The method  claim 14 , wherein the isolated antigen, or an antigenic fragment thereof is ESAT-6 and Ag85B. 
     
     
         24 . The method of any one of  claims 14  to  23 , wherein the droplets have an average diameter of less than 700 nm. 
     
     
         25 . The method of any one of  claims 14  to  23 , wherein the droplets have an average diameter of about 400 nm. 
     
     
         26 . The method of any one of  claims 14  to  25 , wherein the composition is sequentially administered with  Mycobacterium bovis  bacille Calmette-Guérin (BCG). 
     
     
         27 . The method of any one of  claims 14  to  25 , wherein the composition is concurrently administered with  Mycobacterium bovis  bacille Calmette-Guérin (BCG). 
     
     
         28 . The method of any one of  claims 14  to  27 , wherein the composition is formulated into a dosage form selected from the group consisting of a liquid dispersion, gel, aerosol, nasal aerosol, ointment, cream, semi-solid dose forms, and suspensions. 
     
     
         29 . The method of any one of  claims 14  to  27 , wherein the composition is formulated into a nasal aerosol. 
     
     
         30 . The method of any one of  claims 14  to  27 , wherein the composition is a modified release formulation. 
     
     
         31 . A method of screening a composition of the invention for an immune response
 (i) administering the composition to be screened to a screening platform;   (ii) infecting the screening platform with a strain of mycobacteria;   (iii) measuring the immune response in the screening platform;   (iv) comparing the immune response of the screening platform in step (iii) to a control screening platform that was not administered the composition;   wherein if there is a difference, the composition elicits an immune response.   
     
     
         32 . The method of  claim 31  wherein the immune response is a T cell response. 
     
     
         33 . The method of  claim 32  wherein the immune response is a reduction in the delay of T cell response. 
     
     
         34 . The method of  claim 32  wherein the immune response is an increase of T cell response. 
     
     
         35 . A method of screening a composition of the invention for an immune response
 (i) administering the composition to be screened to a screening platform;   (ii) infecting the screening platform with a strain of mycobacteria;   (iii) measuring the immune response in the screening platform;   (iv) comparing the immune response of the screening platform in step (iii) to a control screening platform that was not administered the composition;   wherein, dendritic cells can be administered before, after, or simultaneously at the time of infection;   wherein if there is a difference in immune response between the screening platform in step (iii) and the control screening platform, the composition elicits an immune response.   
     
     
         36 . The method of  claim 35  wherein the immune response is a T cell response. 
     
     
         37 . The method of  claim 36  wherein the immune response is a reduction in the delay of T cell response. 
     
     
         38 . The method of  claim 36  wherein the immune response is an increase of T cell response. 
     
     
         39 . The method of  claim 35  wherein the dendritic cells are activated. 
     
     
         40 . The method of  claim 35  wherein the dendritic cells are primed. 
     
     
         41 . The method of  claim 35  wherein the dendritic cells are primed and activated.

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