Method of modulating mucosal immunogenicity
Inventors
Hsu, Yu-Shen • Chang, Mingi • KANG, SSU-WEI
Assignees
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Publication Number
US-12589149-B2
Publication Date
2026-03-31
Expiration Date
Abstract
The present disclosure provides a novel method for modulating mucosal immune response, comprising administering an antigen to a mucosal site of a subject in need thereof, and administering an immunomodulator to a different anatomical mucosal site of said subject. The antigen may be administered to sublingual mucosa and the immunomodulator may be administered to intranasal mucosa. An immune response involving production of IgG and IgA against the antigen may be elicited.
Core Innovation
The described invention relates to a mucosal immunization strategy for modulating a mucosal immune response. An antigen is administered to a sublingual mucosa or an oral mucosa of a subject, while an immunomodulator is administered to an intranasal mucosa. The antigen is an immunogen, and the immunomodulator is detoxified Escherichia coli heat-labile toxin (LTh(αK)).
The immunomodulator is characterized as not inducing IL-6 from cells in contact. Immune responses elicited by the strategy can involve antigen-specific IgG and IgA, including IgG subclasses and IgA subclasses. The immune modulation can be directed toward upregulation or downregulation, with additional immune response components including IgM and cell-mediated immunity as described in the disclosed summary.
The disclosure provides examples in which intranasal LTh(αK) co-administration with sublingual influenza vaccines increases serum IgG and mucosal IgA. The approach is also described as enhancing anti-house dust mite (HDM) IgG and IgA in allergic/airway challenge models and increasing anti-ragweed IgG, with treatment-dependent durability. The immunization outcomes are described in the context of mucosal immunity and antigen-specific antibody responses.
Claims Coverage
The independent claim defines a two-site mucosal method using an antigen at sublingual/oral mucosa and a detoxified Escherichia coli heat-labile toxin immunomodulator at intranasal mucosa, targeting modulation of antigen-specific mucosal and systemic immune responses. Dependent claims add functional constraints, specified antibody components, and modulation direction, as well as particular examples for influenza and allergen-related antigens.
Two-site mucosal antigen and intranasal immunomodulator administration
Administering an antigen to a sublingual mucosa or an oral mucosa of a subject in need thereof; and administering an immunomodulator to an intranasal mucosa of said subject.
Detoxified Escherichia coli heat-labile toxin immunomodulator
The antigen is an immunogen, and the immunomodulator is detoxified Escherichia coli heat-labile toxin (LTh(αK)).
Immunomodulator that does not induce IL-6 from contacted cells
The method is characterized by an immunomodulator that does not induce IL-6 production in cells it contacts.
Antigen-specific IgG including IgG subclasses as a component of the immune response
The method is defined such that the immune response includes production of antigen-specific IgG and one or more of its subclasses.
Immune modulation including downregulation of immune components
The method is further defined such that the immune response includes downregulation of immune components.
Seasonal influenza vaccine as an influenza A virus-like or influenza B virus-like vaccine
The method is performed where the seasonal influenza vaccine is either an influenza A virus-like vaccine or an influenza B virus-like vaccine.
Overall claim coverage centers on modulating mucosal immune responses by pairing sublingual/oral immunogen administration with intranasal administration of detoxified Escherichia coli heat-labile toxin (LTh(αK)), with additional claimed constraints regarding IL-6 non-induction and specified antigen-specific antibody components and modulation direction. Dependent claims further narrow antigen examples to influenza A/B virus-like vaccines.
Stated Advantages
Enhances serum IgG and mucosal IgA following co-administration with sublingual influenza vaccines.
Enhances anti-house dust mite (HDM) IgG and IgA in allergic/airway challenge models.
Increases anti-ragweed IgG with treatment-dependent durability.
The immunomodulator is characterized as not inducing IL-6 from cells in contact.
Documented Applications
Co-administration with sublingual influenza vaccines to enhance antigen-specific serum IgG and mucosal IgA responses.
Allergic/airway challenge models using house dust mite (HDM) extract, enhancing anti-HDM IgG and IgA.
Treatment involving ragweed pollen extract, increasing anti-ragweed IgG with treatment-dependent durability.
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