Stable Anthrax Vaccine Formulations

Abstract

Formulations of anthrax protective antigen are provided that are stable in storage for prolonged periods. Methods of using the formulations to prepare vaccine are also provided. Vaccines comprising the formulations are useful, for example, to protect against anthrax infection.

1 - 16 . (canceled) 
     
     
         17 . A stable vaccine for stimulating an immune response to a  Bacillus anthracis  protective antigen comprising:
 a) a purified  B. anthracis  protective antigen protein; and   b) a glycine formulation buffer; and   c) a pharmaceutically acceptable adjuvant.   
     
     
         18 . The vaccine of  claim 17 , wherein said glycine formulation buffer comprises about 50 mM to about 500 mM glycine. 
     
     
         19 . The vaccine of  claim 18 , wherein said glycine formulation buffer comprises about 250 mM glycine, about 25 mM sodium phosphate and about 0.01% polysorbate 80. 
     
     
         20 . The vaccine of  claim 17 , wherein said glycine formulation buffer further comprises proline and/or alanine 
     
     
         21 . The vaccine of  claim 17 , wherein said glycine formulation buffer is at about pH 6.2-8.0. 
     
     
         22 . The vaccine of  claim 17 , wherein said glycine formulation buffer is at about pH 7.0. 
     
     
         23 . The vaccine of  claim 17 , wherein said glycine formulation buffer is at about pH 7.4. 
     
     
         24 . (canceled) 
     
     
         25 . The vaccine of  claim 17 , wherein said adjuvant is selected from the group consisting of alhydrogel, CpG, an immunostimulatory sequence (ISS) and calcium phosphate. 
     
     
         26 . The vaccine of  claim 25 , wherein said adjuvant is Alhydrogel. 
     
     
         27 . The vaccine of  claim 26 , wherein said vaccine comprises about 750 μg aluminum. 
     
     
         28 . The vaccine of  claim 17 , wherein said purified  B. anthracis  protective antigen protein is produced from an asporogenic  B. anthracis  bacterium. 
     
     
         29 . The vaccine of  claim 28 , wherein said asporogenic  B. anthracis  bacterium is a ΔSterne-1(pPA102)CR4 strain of bacteria. 
     
     
         30 . The vaccine of  claim 17 , wherein said purified  B. anthracis  protective antigen protein comprises amino acids 30-735 of SEQ ID NO: 1. 
     
     
         31 . The vaccine of  claim 17 , wherein said purified  B. anthracis  protective antigen protein comprises SEQ ID NO: 1. 
     
     
         32 . The vaccine of  claim 17 , wherein said vaccine comprises at least about 25 μg purified  B. anthracis  protective antigen protein. 
     
     
         33 . (canceled) 
     
     
         34 . (canceled) 
     
     
         35 . The vaccine of  claim 17 , wherein said vaccine comprises at least about 25 μg purified  B. anthracis  protective antigen protein and about 750 μg aluminum. 
     
     
         36 - 45 . (canceled) 
     
     
         46 . A method of preventing or treating an anthrax disease comprising administering a pharmaceutically effective amount of the vaccine of  claim 17  to a subject. 
     
     
         47 . The method of  claim 46 , wherein said anthrax disease is inhalation anthrax. 
     
     
         48 . A method of inducing an immune response in a subject comprising administering to the subject a vaccine of  claim 17 . 
     
     
         49 . A method of vaccinating a subject against anthrax comprising administering to the subject a vaccine of  claim 17 . 
     
     
         50 . The vaccine of  claim 17 , wherein the vaccine is a liquid solution or suspension.