Immunogenic Substances Comprising a Polyinosinic Acid - Polycytidilic Acid Based Adjuvant

Abstract

The present invention provides a polynucleotide adjuvant (PICKCa) composition and methods of use in eliciting an immune response, in particular a mucosal immune response. The polynucleotide adjuvant comprises of a polyriboinosinic-polyribocytidylic acid (PIC), at least one antibiotic and at least one positive ion. The present invention also provides an immunogenic composition comprising the polynucleotide adjuvant composition together with other immunogenic compositions such as an antigen (e.g., as in a vaccine) selected from viral, bacterial, fungal, parasitic and/or cancer antigens. The present invention further contemplates methods of use of such adjuvant compositions, particularly in eliciting an immune response, in particular a mucosal immune response to an antigenic compound.

1 - 23 . (canceled) 
     
     
         24 . An immunogenic composition suitable for human use, the immunogenic composition comprising:
 (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one antibiotic, and at least one positive ion; and   (b) at least one antigen.   
     
     
         25 . The immunogenic composition according to  claim 24 , wherein the immunogenic composition comprises polynucleotide adjuvant composition molecules heterogenous for molecular size, wherein the molecular weight range is from about 6.4-24.0 Svedbergs. 
     
     
         26 . The immunogenic composition according to  claim 24 , wherein the immunogenic composition comprises polynucleotide adjuvant composition molecules heterogeneous for molecular weight, wherein the molecular weight range is from about 12.8 to 24.03 Svedbergs. 
     
     
         27 . The immunogenic composition according to  claim 24 , wherein the immunogenic composition comprises polynucleotide adjuvant composition molecules heterogeneous for molecular weight, wherein the molecular weight range is from about 13.5 to 24.03 Svedbergs. 
     
     
         28 . The immunogenic composition according to  claim 24 , wherein the antibiotic is kanamycin and the positive ion is calcium. 
     
     
         29 . The immunogenic composition according to  claim 24 , wherein the polynucleotide adjuvant composition is capable of eliciting a balanced humoral and cell mediated immune response. 
     
     
         30 . The immunogenic composition according to  claim 24 , wherein the antigen is selected from the group consisting of adeniviridae, arenaviridae, astroviridae, bunyaviridae, cliciviridae, flaviviridae, hepadnaviridae, hepatitis delta virus, hepesviridae, mononegavirales, nidovirales, piconaviridae, orthomyxoviridae, papillomaviridae, parvoviridae, polyomaviridae, poxyiridae, reoviridae, retroviridae, togaviridae, actinobacteria, chlamydiae, firmicutes, proteobacteria or spirochaetes, ascomycotaor basidiomycota, phylum sarcomastigophora, phylum apicomplexa, phylum ciliophora, phylum plathyhelminthes, phylum nematoda and phylum arthropoda. 
     
     
         31 . The immunogenic composition according to  claim 30 , wherein the antigen is a hepadnaviridae antigen. 
     
     
         32 . The immunogenic composition according to  claim 31 , wherein the hepadnaviridae antigen is hepatitis B virus surface antigen. 
     
     
         33 . The immunogenic composition according to  claim 32 , wherein the ratio of the polynucleotide adjuvant composition to hepatitis B virus surface antigen is greater than 10 to 1. 
     
     
         34 . The immunogenic composition according to  claim 30 , wherein the antigen is a flaviviridae antigen. 
     
     
         35 . The immunogenic composition according to  claim 34 , wherein the antigen is Japanese encephalitis virus. 
     
     
         36 . The immunogenic composition according to  claim 30 , wherein the antigen is a  Mycobacterium  antigen. 
     
     
         37 . The immunogenic composition according to  claim 36 , wherein the antigen is  Mycobacterium tuberculosis.    
     
     
         38 . The immunogenic composition according to  claim 24 , wherein the composition comprises two or more antigens. 
     
     
         39 . A kit for eliciting an immune response to an antigen in a human, comprising:
 a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one antibiotic, and at least one positive ion, wherein the immunogenic composition comprises polynucleotide adjuvant composition molecules heterogeneous for molecular weight, and   an antigen.   
     
     
         40 . The kit according to  claim 39 , further comprising a device for intranasal delivery. 
     
     
         41 . A method for eliciting an immune response to an antigen, the method comprising:
 administering to the host the immunogenic composition of  claim 24 .   
     
     
         42 . The method according to  claim 41 , wherein the administering comprises parenteral injection, intramuscular injection, intraperitoneal injection, intravenous injection, subcutaneous injection, intranasal delivery, topical delivery, transdermal delivery or intradermal delivery. 
     
     
         43 . The method according to  claim 41 , wherein the host has an infectious disease and said administering of the immunogenic compound elicits an immune response against the pathogen causing the infectious disease.