Novel compositions of saponin adjuvants and excipients

Abstract

Certain novel compositions of the adjuvant saponin QS-21 having improved properties are disclosed. The compositions of the present invention are designed (1) to minimize the lytic effects of QS-21, (2) to improve the tolerance of QS-21 containing formulations in humans or other animals, (3) to stabilize the QS-21 from alkaline hydrolysis and/or (4) to maintain the high adjuvant potency of the QS-21 product. These compositions may be employed with vaccines comprising proteins or peptides, polysaccharides, lipids, or nucleic acids.

1 - 45 . (canceled)  
     
     
         46 . A method for enhancing an immune response to an antigen in an individual to which said antigen is administered comprising administering to said individual an amount, effective to enhance said immune response, of a composition comprising a saponin adjuvant and an excipient, said excipient being selected from the group consisting of a β-cyclodextrin, a human serum albumin, a deacylsaponin, a Polysorbate, and Triton X-100.  
     
     
         47 . The method of  claim 46 , wherein the saponin adjuvant is a heterogeneous saponin adjuvant.  
     
     
         48 . The method of  claim 47 , wherein the heterogenous saponin adjuvant is Quil-A.  
     
     
         49 . The method of  claim 46 , wherein the saponin adjuvant comprises two or more substantially pure saponins selected from the group consisting of QS-7, QS-17, QS-18, and QS-21.  
     
     
         50 . The method of  claim 46 , wherein the saponin adjuvant is a substantially pure saponin adjuvant.  
     
     
         51 . The method of  claim 50 , wherein the substantially pure saponin adjuvant is selected from the group consisting of QS-7, QS-17, QS-18 and QS-21.  
     
     
         52 . The method of  claim 50 , wherein the substantially pure saponin adjuvant is QS-21.  
     
     
         53 . The method of  claim 50 , wherein the substantially pure saponin adjuvant is QS-7.  
     
     
         54 . The method of  claim 46 , wherein the antigen is a peptide, a protein, a polysaccharide, a lipid, or a nucleic acid.  
     
     
         55 . The method according to  claim 46 , wherein the excipient is a Polysorbate or Triton X-100.  
     
     
         56 . The method according to  claim 55 , wherein the excipient is a Polysorbate.  
     
     
         57 . The method according to  claim 56 , wherein the Polysorbate is Polysorbate 20, Polysorbate 40, Polysorbate 60, or Polysorbate 80.  
     
     
         58 . The method according to  claim 46 , wherein the excipient is β-cyclodextrin.  
     
     
         59 . The method according to  claim 58 , wherein the β-cyclodextrin is hydroxypropyl-β-cyclodextrin.  
     
     
         60 . The method of  claim 46 , wherein the excipient is a human serum albumin.  
     
     
         61 . The method of  claim 46 , wherein the excipient is a deacylsaponin (“DS”).  
     
     
         62 . The method of  claim 61 , wherein the excipient is DS-1.  
     
     
         63 . The method of  claim 46 , wherein said antigen and said composition are administered to said individual concurrently.  
     
     
         64 . The method of  claim 46 , wherein said individual is a mammal.  
     
     
         65 . The method of any one of claims  46 - 53 ,  56 ,  58  and  63 , wherein said individual is a human.