Immunogenic substances comprising a polyinosinic acid-polycytidilic acid based adjuvant

Abstract

The present invention provides a polynucleotide adjuvant composition and methods of use in eliciting an immune response. 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). The present invention further contemplates methods of use of such adjuvant compositions, particularly in eliciting an immune response to an antigenic compound.

1 . An immunogenic composition comprising a PIKA adjuvant and an antigen, wherein the immunogenic composition is formulated for sustained release.  
   
   
       2 . An immunogenic composition comprising PIKA adjuvant and a 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 PIKA adjuvant and a bacterial antigen wherein the antigen is an antigen of actinobacteria, chlamydiae, firmicutes, proteobacteria or spirochaetes.  
   
   
       4 . An immunogenic composition comprising PIKA adjuvant and a fungal antigen wherein the antigen is an antigen of ascomycotaor or basidiomycota.  
   
   
       5 . An immunogenic composition comprising PIKA adjuvant and a 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 PIKA adjuvant and a 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 PIKA adjuvant and 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 or phylum arthropoda.  
   
   
       8 . An immunogenic composition comprising  claims 1  to  7  plus an immunomodulator  
   
   
       9 . An immunogenic composition of any of  claims 1  to  7  where the antigen is an inactivated microorganism, attenuated microorganism, recombinant polypeptide or synthetic polypeptide.  
   
   
       10 . The immunogenic composition of any of  claims 1  to  7  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, powders, tablets or lozenges.  
   
   
       11 . The immunogenic composition of any of  claims 1  to  7  wherein at least one of the adjuvant composition or the immunogenic composition is freeze-dried.  
   
   
       12 . A kit comprising the immunogenic composition of any of  claims 1  to  7 .  
   
   
       13 . 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  7 .  
   
   
       14 . The method of  claim 13 , wherein said administering is by parenteral injection, intramuscular injection, intraperitoneal injection, intravenous injection, subcutaneous injection, topical delivery, transdermal delivery or intradermal delivery.  
   
   
       15 . The use of the immunogenic composition of any of  claim 1  to  7  for the preparation of a medicament for enhancing the immune response of a host to the antigen.  
   
   
       16 . The method of  claim 13 , wherein the host is human.  
   
   
       17 . The method of  claim 13 , wherein the host is a non-human animal.