Vaccine adjuvant composition comprising inulin particles
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Publication Number
US-11110167-B2
Publication Date
2021-09-07
Expiration Date
Abstract
The present invention provides a pharmaceutically acceptable composition comprising: particles of inulin; a substance comprising or consisting of one or more pathogen-associated molecular patterns (PAMPs), and an antigen for use 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.
Core Innovation
The invention relates to an immunogenic vaccine composition comprising manufactured particles of delta inulin, a synthetic substance comprising one or more, but no greater than ten distinct molecular species of pathogen-associated molecular pattern (PAMP), and an antigen. The synthetic PAMP substance provides innate immune activation in combination with the delta inulin particles and the antigen.
The disclosed approach addresses the need to balance immune activation with control of inflammation, toxicity, and reactogenicity when using innate immune activators. The compositions use crystalline inulin particles in combination with PAMPs as innate immune activators, including formulations designed to limit inflammation while still enhancing immune responses.
The invention further describes combinations designed to augment humoral and cellular immunity, including improvements in antibody responses and T-cell proliferation, and includes characterization relating to inflammatory pathway activation in relevant assays. The provided summary context identifies delta inulin particle formulations evaluated together with innate immune activators, particularly CpG TLR9 agonists.
Claims Coverage
The independent claim is an immunogenic vaccine composition defined by a three-part combination: delta inulin particles, a synthetic PAMP substance limited to up to ten distinct molecular species, and an antigen. Dependent claims refine this core by specifying PAMP classes, PAMP molecular types, PAMP examples, antigen examples, and an optional antigen-binding carrier material; overall, the claim set contains one independent claim and multiple dependent refinements.
Delta inulin particle-based immunogenic vaccine composition
An immunogenic vaccine composition comprising manufactured particles of delta inulin, a synthetic substance comprising one or more, but no greater than ten distinct molecular species of pathogen-associated molecular pattern (PAMP), and an antigen.
Synthetic PAMP selected from innate receptor agonist/ligase categories
A vaccine composition including a synthetic substance comprising or consisting of a PAMP selected from agonists or ligases associated with Toll-like receptors (TLRs), RIG ligase, NOD-like receptors, RNA helicase receptors, or NALP.
Synthetic PAMP selected from specified molecular types
The synthetic substance containing or consisting of a PAMP is selected from lipoteichoic acid, RNA, DNA, oligonucleotide, or an unmethylated polynucleotide molecule.
CG-motif-containing oligonucleotide PAMP
The vaccine composition includes a synthetic PAMP that is a synthetic CG-motif-containing oligonucleotide.
Antigen selected from specified viral pathogens
The antigen is selected from influenza virus, hepatitis B virus, rabies virus, or a coronavirus from the Coronaviridae family.
Antigen-binding carrier material addition
The vaccine composition further includes an antigen-binding carrier material.
Overall claim coverage centers on a delta inulin-based immunogenic vaccine composition that combines delta inulin particles with a synthetic PAMP substance limited to up to ten distinct molecular species and an antigen, with refinements specifying particular innate receptor-linked PAMP categories, PAMP molecular types, antigen selections for particular viruses/coronaviruses, and an optional antigen-binding carrier material.
Stated Advantages
Synergistic immune memory when inulin particles are co-administered with PAMPs.
PAMP dose-sparing with reduced inflammation/toxicity.
Reduced inflammation/toxicity/reactogenicity.
Inulin particles show surprising anti-inflammatory behavior, including downregulation of pro-inflammatory genes and lack of NFκB activation while still enhancing adaptive immune responses with PAMP co-administration.
Synergistically enhanced humoral and cellular immunity, including increased total IgG, IgG2a, IgM and improved T-cell proliferation.
Antigen-sparing effects.
Improved modulation of typical Th1/Th2 shifts caused by CpG.
Reduced IL-1 pathway activation and altered IL-1 antagonist gene expression in human PBMC/whole blood assays.
Reported decrease in headache frequency in a human pandemic influenza study.
Documented Applications
Vaccine and immunogenic compositions intended for immunogenicity testing and protective efficacy in challenge models, including influenza (TIV and TIV+CpG) and protection in lethal viral challenge models.
Use of influenza and other antigens, including influenza haemagglutinin (HA), hepatitis B virus antigens (HBsAg), rabies virus antigens, and coronavirus-related antigens, within immunogenic vaccine compositions combined with defined PAMPs.
Use of formulations and kits separating an inulin/anti-inflammatory component from a PAMP component as part of the disclosed vaccine kit formats.
Vaccine bioassays and immunogenicity evaluations in animal models including mice, neonatal/elderly, ferrets, and horses, using vaccine antigens such as influenza, hepatitis B, rabies, malaria MSP proteins, SARS-CoV, pandemic H5N1, and Japanese encephalitis.
Human PBMC/whole blood assays assessing IL-1 pathway and related gene expression with inulin particle adjuvant combinations with CpG.
A human pandemic influenza study reporting reduced headache frequency in the context of a rHA vaccine combined with inulin particles.
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