Compositions and methods for a multi-adjuvant only approach to immunoprophylaxis for preventing infections

Abstract

This disclosure provides a new vaccine composition and methods for its use. The composition contains an effective amount of each of: an aluminum hydroxide, a mono-phosphoryl lipid (MPL), and a whole glucan particles (WGP) but no an antigen that raises an immune response against a bacterial or fungal infection.

1 . A composition comprising an effective amount of each of: aluminum hydroxide, MPL mono-phosphoryl lipid (MPL), and whole glucan particles (WGP), with the proviso that the composition does not comprise an antigen effective to induce an immune response against a fungal or bacterial pathogen. 
     
     
         2 - 22 . (canceled) 
     
     
         23 . The composition of  claim 1 , further comprising an effective amount of a mannan. 
     
     
         24 . The composition of  claim 1 , wherein the aluminum hydroxide is Alhydrogel®. 
     
     
         25 . The composition of  claim 1 , wherein the effective amount comprises:
 a. from about 0.1 to about 10 mg/ml of aluminum hydroxide;   b. from about 0.1 to about 10 mg/ml of MPL;   c. combined in a ratio of from about 1:1 to about 1:20 for elements 25a. and 25b. to WGP.   
     
     
         26 . The composition of  claim 1 , further comprising a pharmaceutically acceptable carrier. 
     
     
         27 . The composition of  claim 23 , wherein the effective amount of mannose comprises from about 0.01 mg/ml to about 1 mg/ml. 
     
     
         28 . A method to enhance immunity in a subject against an infection caused by a bacterial or fungal pathogen, the method comprising administering to the subject an effective amount of a composition of  claim 1 . 
     
     
         29 . The method of  claim 28 , wherein the bacterium is selected from  S. aureus, A. baumannii, K. Pneumoniae, P. aeruginosa, E. coli, Enterobacter  spp.,  Serratia, Stenotrophomonas , and the fungus is selected from  Candida  spp. 
     
     
         29 . The method of  claim 28 , wherein the composition is administered by a method comprising intramuscular, subcutaneous, or intravenous administration. 
     
     
         30 . The method of  claim 28 , wherein the composition is administered once, twice, or three times over the period of one to three months. 
     
     
         31 . The method of  claim 28 , wherein the subject is at risk of a bacterial or fungal infection. 
     
     
         32 . The method of  claim 28 , wherein the subject is infected with the bacterial or fungal microorganism. 
     
     
         33 . The method of  claim 28 , further comprising assaying the subject for a bacterial or fungal infection prior to administration of the composition. 
     
     
         34 . A method to treat a disorder used by a bacterial or fungal infection in a subject in need thereof, the method comprising administering an effective amount of the composition of  claim 1 . 
     
     
         35 . The method of  claim 34 , wherein the bacterial or fungal microorganism is selected from  S. aureus, A. baumannii, K. Pneumoniae, P. aeruginosa, E. coli, Enterobacter  spp.,  Serratia, Stenotrophomonas, Candida  spp. 
     
     
         36 . The method of  claim 34 , wherein the composition is administered by a method comprising parenteral administration, including subcutaneous, intra-muscular, or intravenous. 
     
     
         37 . The method of  claim 34 , wherein the composition is administered once, twice, or three times. 
     
     
         38 . The method of  claim 34 , further comprising assaying the subject for a bacterial or fungal infection prior to administration of the composition. 
     
     
         39 . A kit comprising the composition of  claim 1  and instructions for use. 
     
     
         40 . A method to identify an compound or agent that provides a benefit selected from one or more of: enhances immunity against a bacterial or fungal microbial infection or treats a bacterial or fungal infection or a disease related to a bacterial or fungal microbial infection, the method comprising admixing the compound or agent with the composition of  claim 1  and administering the admixed composition to a non-human subject infected with a bacterial or fungal microorganism and assaying for post-administration infection or survival, wherein the compound or agent that enhances the activity of the composition of  claim 1  is an agent that provides the benefit.