Dry solid aluminum adjuvant-containing vaccines and related methods thereof

Abstract

Described herein are dry vaccine compositions and methods of freezing aluminum-containing vaccines such that when converted into a dried powder, the dry vaccine can be readily reconstituted to form a stable liquid vaccine without significant loss of activity.

1 . A dry vaccine comprising:
 an antigenic protein and an aluminum adjuvant, wherein at least 75% of said antigenic protein is adsorbed to said aluminum adjuvant.   
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . The dry vaccine of  claim 1 , wherein said aluminum adjuvant is aluminum hydroxide, aluminum phosphate, potassium phosphate, or potassium aluminum sulfate. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . The dry vaccine of  claim 1 , comprising less than 2% water. 
     
     
         8 . The dry vaccine of  claim 1 , wherein at least 80% of said antigenic protein is adsorbed to said aluminum adjuvant. 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . The dry vaccine of  claim 1 , further comprising an excipient. 
     
     
         12 - 16 . (canceled) 
     
     
         17 . A method for preparing a vaccine thin film comprising:
 applying a liquid vaccine to a freezing surface;   allowing said liquid vaccine to disperse and freeze on said freezing surface thereby forming a vaccine thin film.   
     
     
         18 . The method of  claim 17 , wherein said liquid vaccine comprises an aluminum adjuvant. 
     
     
         19 . The method of  claim 18 , wherein said aluminum adjuvant comprises aluminum hydroxide, aluminum phosphate, aluminum sulfate, or aluminum potassium sulfate. 
     
     
         20 . The method of  claim 17 , wherein said liquid vaccine comprises about 0.5% to 5% (wt/vol) of an aluminum adjuvant/liquid vaccine. 
     
     
         21 . The method of  claim 17 , wherein said liquid vaccine comprises an excipient. 
     
     
         22 . The method of  claim 17 , wherein said liquid vaccine comprises about 0.5% to 5% (wt/vol) of an excipient/liquid vaccine. 
     
     
         23 - 28 . (canceled) 
     
     
         29 . The method of  claim 17 , further comprising removing the solvent from the vaccine thin film to form a dry vaccine. 
     
     
         30 . The method of  claim 29 , wherein said dry vaccine comprises an antigenic protein and an aluminum adjuvant, wherein at least 75% of said antigenic protein is adsorbed to said aluminum adjuvant. 
     
     
         31 .- 36 . (canceled) 
     
     
         37 . The method of  claim 30 , wherein said dry vaccine comprises an excipient. 
     
     
         38 - 40 . (canceled) 
     
     
         41 . The method of  claim 29 , wherein said removing of the solvent comprises lyophilization. 
     
     
         42 . The method of  claim 29 , further comprising solvating said dry vaccine thereby forming a reconstituted liquid vaccine. 
     
     
         43 - 45 . (canceled) 
     
     
         46 . The method of  claim 42 , wherein the level of antigenic protein adsorbed to said aluminum adjuvant of said reconstituted liquid vaccine is at least 90% of the level of antigenic protein adsorbed to said aluminum adjuvant of said liquid vaccine. 
     
     
         47 . The method of  claim 42 , wherein said reconstituted liquid vaccine comprises particles, wherein said particles comprise said antigenic protein adsorbed to said aluminum adjuvant. 
     
     
         48 . The method of  claim 47  wherein said particles have an average diameter of between 10 nm and 5 μm. 
     
     
         49 - 53 . (canceled) 
     
     
         54 . A method of treating a disease in a patient in need of such treatment, said method comprising administering a therapeutically effective amount of a solvated dry vaccine of  claim 1  to said patient, wherein said disease is diphtheria, tetanus, pertussis, influenza, pneumonia, otitis media, bacteremia, meningitis, hepatitis, cirrhosis, anthrax poisoning, rabies, warts, poliomyelitis, Japanese encephalitis, or cancer. 
     
     
         55 . (canceled)