Vaccine adjuvant composition comprising inulin particles

Abstract

The present invention provides a composition comprising or consisting of inulin particles for use in the reduction or inhibition of inflammation, and/or for treating or preventing inflammatory disease, in a subject. Also provided is a pharmaceutically acceptable composition comprising: particles of inulin; and a substance comprising or consisting of one or more pathogen-associated molecular patterns (PAMPs), or an equivalent kit of parts, and methods and uses of the composition and kit for inducing or modulating an immune response in a subject, such as modulating an immune response to an antigen or allergen and/or as a vaccine. Also provided is a single-dose vaccine composition comprising inulin particles, an antigen and, optionally, an antigen-binding carrier material, and methods and uses of the vaccine.

1 . A composition comprising or consisting of inulin particles for use in the reduction or inhibition of inflammation, or for treating or preventing inflammatory disease, in a subject. 
     
     
         2 . The composition of  claim 1  wherein, separately, simultaneously or sequentially, relative to the administration of the inulin particles, the subject is also exposed to a pro-inflammatory substance or composition, and the composition comprising or consisting of inulin particles is for use in reducing or inhibiting the inflammatory response of the subject to the pro-inflammatory substance or composition. 
     
     
         3 . The composition of  claim 2 , wherein the pro-inflammatory substance or composition contains a substance comprising or consisting of a pathogen-associated molecular pattern (PAMP), and the composition comprising inulin particles is for use in reducing or inhibiting the inflammatory response of the subject to the PAMP. 
     
     
         4 . The composition of  claim 3 , wherein the composition comprising inulin particles and the pro-inflammatory composition are administered to the subject simultaneously, such as in a single administration containing a mixture of both compositions. 
     
     
         5 . The composition of  claim 3  wherein the composition further comprises an antigen or allergen. 
     
     
         6 . A pharmaceutically acceptable composition comprising:
 (a) the composition of  claim 1 ;   (b) a substance comprising or consisting of one or more, but no greater than ten distinct molecular species of pathogen-associated molecular pattern (PAMP); and further comprising   (c) one or more additional substances selected from the group consisting of an antibody, antisense oligonucleotide, protein, antigen, allergen, a polynucleotide molecule, recombinant viral vector, a whole microorganism, or a whole virus.   
     
     
         7 . A kit of parts comprising: (a) a first container that contains a composition comprising or consisting of the composition of  claim 1 ; and (b) a second container that contains a substance comprising or consisting of a pathogen-associated molecular pattern (PAMP). 
     
     
         8 . The composition of any of  claim 5  wherein the substance comprising or consisting of a PAMP is an innate immune activator, and comprises or consists of a substance that is selected from the group consisting of an agonist of one or more of a Toll-like receptor (TLR), a RIG ligase, a NOD-like receptor, a C type Lectin, a complement receptor, an Fc receptor, a scavenger receptor, a RNA helicase receptor, or a NALP or comprises or consists of a substance that is selected from the group consisting of lipoteichoic acid, RNA, DNA, CpG oligonucleotide, and an unmethylated polynucleotide molecule. 
     
     
         9 . The composition of  claim 3 , wherein the substance comprising or consisting of a PAMP is an innate immune activator, and comprises or consists of a substance that is selected from the group consisting of an agonist of one or more of a Toll-like receptor (TLR), a RIG ligase, a NOD-like receptor, a C type Lectin, a complement receptor, an Fc receptor, a scavenger receptor, a RNA helicase receptor, or a NALP, or comprises or consists of a substance that is selected from the group consisting of lipoteichoic acid, RNA, DNA, CpG oligonucleotide, and an unmethylated polynucleotide molecule. 
     
     
         10 . The composition of  claim 5 , wherein the inulin particle comprises or consists of inulin which is selected from one or more of gamma inulin, delta inulin and epsilon inulin, or combinations of any one or more of these inulins with aluminium phosphate or aluminium hydroxide. 
     
     
         11 . The composition of  claim 3 , wherein the composition comprising or consisting of inulin particles, and the pro-inflammatory composition, further comprises one or more additional substances selected from the group consisting of an antibody, antisense oligonucleotide, protein, antigen, allergen, a polynucleotide molecule, recombinant viral vector, a whole microorganism, or a whole virus. 
     
     
         12 . The composition of  claim 1 , wherein the composition comprising or consisting of inulin particles is a composition that comprises or consists of particles of at least two inulin preparations, wherein the preparations differ in the polymorphic form of the inulin present and/or the presence or species of an antigen-binding carrier material. 
     
     
         13 . A method for preventing or modulating an inflammatory response in a subject, wherein said method comprises administering to the subject a therapeutically effective amount of the composition according to  claim 1 . 
     
     
         14 . A composition according to  claim 1  for use in preventing or modulating an inflammatory response in a subject. 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . A method for enhancing an immune response to an antigens while at the same time preventing or modulating inflammation related side effects wherein said method comprises administering to a subject a therapeutically effective amount of a composition according to  claim 5 . 
     
     
         18 . A composition according to  claim 5 , for use in enhancing an immune response to an antigen while reducing inflammation related side effects. 
     
     
         19 . A method for vaccination of a subject, the method comprising administering to the subject a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         20 . A composition according to  claim 6  for use as a vaccine with reduced inflammation related side effects. 
     
     
         21 . A method for allergen desensitisation of a subject with reduced inflammation related side effects, the method comprising administering to the subject a therapeutically effective amount of the composition according to  claim 6  wherein said composition also comprises an allergen. 
     
     
         22 . A composition according to  claim 6  wherein said composition also comprises an allergen for use in allergen desensitisation of a subject with minimal inflammation related side effects. 
     
     
         23 . A method for the manufacture of a vaccine, the method comprising the step of combining an antigen with components (a) and (b) of the composition of  claim 6  thereby to produce a vaccine composition. 
     
     
         24 . Use of the composition of  claim 3  as an adjuvant in a vaccine. 
     
     
         25 . A single-dose vaccine composition comprising the composition according to  claim 6 , and an antigen. 
     
     
         26 . A method of vaccinating a subject the method comprising or consisting of administering to the subject a single-dose of the vaccine of  claim 25 . 
     
     
         27 . The single-dose of the vaccine of  claim 25  for use in vaccinating a subject by a method comprising or consisting of administering to the subject a single-dose of the vaccine. 
     
     
         28 . (canceled) 
     
     
         29 . The composition of  claim 6 , wherein the human subject is a child less than 18 years old or an adult at least 40 years old. 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . The composition of  claim 3  wherein the substance comprising or consisting of a PAMP is an innate immune activator, and comprises or consists of a substance that is selected from the group consisting of an agonist of one or more of a Toll-like receptor (TLR), a RIG ligase, a NOD-like receptor, a C type Lectin, a complement receptor, an Fc receptor, a scavenger receptor, a RNA helicase receptor, or a NALP or comprises or consists of a substance that is selected from the group consisting of lipoteichoic acid, RNA, DNA, CpG oligonucleotide, and an unmethylated polynucleotide molecule