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 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) at least one antigen; wherein the composition is formulated for sustained release. 
   
   
       2 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) at least one viral antigen; wherein the antigen is an antigen of adeniviridae, arenaviridae, astroviridae, bunyaviridae, cliciviridae, flaviviridae, hepatitis delta virus, hepeviridae, mononegavirales, nidovirales, piconaviridae, orthomyxoviridae, papillomaviridae, parvoviridae, polyomaviridae, poxyiridae, reoviridae, retroviridae or togaviridae. 
   
   
       3 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) at least one bacterial antigen wherein the antigen is an antigen of actinobacteria, chlamydiae, filmicutes, proteobacteria or spirochaetes. 
   
   
       4 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) at least one fungal antigen wherein the antigen is an antigen of ascomycota or basidiomycota. 
   
   
       5 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) at least one parasitic antigen wherein the antigen is an antigen of phylum sarcomastigophora, phylum apiicomplexa, phylum ciliophora, phylum plathyhelminthes, phylum nematoda or phylum arthropoda. 
   
   
       6 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) at least one cancer antigen wherein the antigen is a cancer antigen of bone, brain, breast, digestive/gastrointestinal, endocrine, eye, genitourinary, germ cell, gynecologic, head and neck, hematological/blood, lung, musculoskeletal, neurologic, respiratory/thoracic or skin cancer. 
   
   
       7 . An immunogenic composition comprising: (a) a polynucleotide adjuvant comprising: a polyriboinosinic-polyribocytidylic acid (PIC), at least one an antibiotic, and at least one positive ion; and (b) a combination of two or more antigens wherein the antigens are antigens of adeniviridae, arenaviridae, astroviridae, bunyaviridae, cliciviridae, flaviviridae, hepatitis delta virus, hepeviridae, mononegavirales, nidovirales, piconaviridae, orthomyxoviridae, papillomaviridae, parvoviridae, polyomaviridae, poxyiridae, reoviridae, retroviridae, togaviridae, actinobacteria, chlamydiae, firmicutes, proteobacteria or spirochaetes, ascomycotaor basidiomycota, phylum sarcomastigophora, phylum apiicomplexa, phylum ciliophora, phylum plathyhelminthes, phylum nematoda and/or phylum arthropoda. 
   
   
       8 . The immunogenic composition according to any one of  claims 1  to  7 , wherein the composition comprises polynucleotide adjuvant composition molecules heterogeneous for molecular weight, wherein the molecular weight is at least 66,000 Daltons. 
   
   
       9 . The immunogenic composition according to any one of  claims 1  to  8 , wherein the composition comprises polynucleotide adjuvant composition molecules heterogeneous for molecular weight, wherein the molecular weight is from about 66,000 to 1,200,000 Daltons. 
   
   
       10 . The immunogenic composition according to any one of  claims 1  to  9 , wherein the composition comprises polynucleotide adjuvant composition molecules heterogeneous for molecular weight, wherein the molecular weight is at least 150,000 Daltons. 
   
   
       11 . The immunogenic composition of any one of  claims 1  to  10 , further comprising at least one immunomodulator. 
   
   
       12 . The immunogenic composition of any one of  claims 1  to  11 , wherein the antigen is an inactivated microorganism, attenuated microorganism, recombinant polypeptide and/or synthetic polypeptide. 
   
   
       13 . The immunogenic composition of any one of  claims 1  to  12  wherein the immunogenic composition or the PIKA adjuvant contained in the immunogenic composition, is in the form of a liquid, liquid solution, liquid drops, a solid, capsules, emulsions, suspensions, elixirs, creams, suppositories, gels, soft capsules, sprays, inhalants, aerosols, tablets, coated tablets, microcapsules, suppositories, dragees, syrups, slurries, enemas, granules, powders, tablets or lozenges. 
   
   
       14 . The immunogenic composition of any one of  claims 1  to  12  wherein at least one of the adjuvant composition or the immunogenic composition is freeze-dried. 
   
   
       15 . A kit comprising the immunogenic composition of any one of  claims 1  to  14 . 
   
   
       16 . A method for enhancing an immune response in a host to an antigen, the method comprising administering to the host the immunogenic composition of any of  claims 1  to  14 . 
   
   
       17 . The method of  claim 16 , wherein the host has an infectious disease and said administering of the antigenic compound elicits an immune response against the pathogen causing the infectious disease. 
   
   
       18 . The method of  claim 16  or  claim 17 , wherein said administering is by parenteral injection, intramuscular injection, intraperitoneal injection, intravenous injection, subcutaneous injection, topical delivery, transdermal delivery or intradermal delivery. 
   
   
       19 . The use of the immunogenic composition of any of  claim 1  to  14  for the preparation of a medicament for enhancing the immune response of a host to the antigen. 
   
   
       20 . The use of  claim 19 , wherein the host has an infectious disease and the administering of the antigen to the host elicits an immune response against the pathogen causing the infectious disease. 
   
   
       21 . The use of  claim 20 , wherein the administering is by parenteral injection, intramuscular injection, intraperitoneal injection, intravenous injection, subcutaneous injection, topical delivery, transdermal delivery or intradermal delivery. 
   
   
       22 . The method of any one of  claims 16  to  18  and the use of any one of  claims 19  to  21 , wherein the host is human. 
   
   
       23 . The method of any one of  claims 16  to  18  and the use of any one of  claims 19  to  21 , wherein the host is a non-human animal.