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Assignees
MemberWest Virginia UniversityWest Virginia UniversityWest Virginia University is a public R1 research institution offering diverse undergraduate and graduate programs across science, engineering, business, creative arts, and media. The university emphasizes experiential learning, research, and innovation, with notable strengths in academic program development, research excellence, community engagement, and a commitment to affordability, career readiness, and student success. WVU supports a vibrant campus environment, industry partnerships, and impactful scholarship, preparing students for careers through hands-on education, research, and applied learning.
West Virginia University is a public R1 research institution offering diverse undergraduate and graduate programs across science, engineering, business, creative arts, and media. The university emphasizes experiential learning, research, and innovation, with notable strengths in academic program development, research excellence, community engagement, and a commitment to affordability, career readiness, and student success. WVU supports a vibrant campus environment, industry partnerships, and impactful scholarship, preparing students for careers through hands-on education, research, and applied learning.
Publication Number
US-11701417-B2
Publication Date
2023-07-18
Expiration Date
Abstract
A vaccine composition for intranasal administration includes a Bordetella pertussis antigen, and an effective adjuvant amount of a high molecular weight glucose polymer. The high molecular weight glucose polymer may be a beta-glucan. The Bordetella pertussis antigen may be an extracellular toxin, an adhesion protein, an outer membrane protein, a receptor protein, a fragment thereof, or a mixture thereof.
Core Innovation
The disclosed invention relates to intranasal pertussis vaccine compositions comprising Bordetella pertussis antigens and a high molecular weight glucose polymer adjuvant that gels in the respiratory tract to support airway localization. The Bordetella pertussis antigens include extracellular pertussis toxoid (PT), filamentous hemagglutinin (FHA), and optionally other adhesins/receptor proteins and fragments, including ACT and RTX. The adjuvant is a beta-glucan, including curdlan and baker’s yeast 1,3-beta/1,3-1,6 beta-glucan copolymers/whole glucan particles, with formulation enabling localization and retention in the upper airway compared with lung.
The patent describes a mechanistic rationale in which beta-glucans signal through Dectin-1 and NF-κB to promote pro-inflammatory responses that support Th1/Th17 immunity. This is linked to mucosal IgA responses, including secretory IgA, as part of the intended immunological outcome following intranasal administration. The document also describes immune-response effects consistent with induction of IL-17 and downstream antibody responses.
The disclosure provides experimental support in mice, including enhanced bacterial clearance and reduced lung inflammatory cytokines such as IL-6. It also reports reduced bacterial burden and neutrophil recruitment, and describes vaccine particle localization/retention in the upper airway versus the lung. The document further reports increased long-term antibody levels and bone marrow antibody-secreting cells.
Claims Coverage
The provided claim set includes four independent claims (clm-00001, clm-00002, clm-00018, clm-00019). Across these independent claims, the core claim coverage centers on vaccine compositions combining Bordetella pertussis extracellular antigens or specified receptor-protein fragments with an effective amount of beta-glucan polymers derived from baker’s yeast, with additional particle-size constraints and antigen selection limitations.
Bordetella pertussis antigen with baker’s yeast 1,3-beta-glucan/1,6-beta-glucan copolymer adjuvant
A vaccine composition comprising an extracellular pertussis toxoid (PT), the adhesion protein filamentous hemagglutinin (FHA), or a combination thereof, and an effective adjuvant amount of a 1,3-beta-glucan/1,6-beta-glucan copolymer derived from baker's yeast with a particle size of 3 μm to 4 μm.
Bordetella pertussis antigen with baker’s yeast beta-glucan polymer adjuvant
A vaccine composition comprising an extracellular pertussis toxoid (PT), the adhesion protein filamentous hemagglutinin (FHA), or a combination thereof, and an effective adjuvant amount of a beta-glucan polymer derived from baker's yeast with a particle size of 3 μm to 4 μm, wherein the beta-glucan polymer is a 1,3-beta-glucan polymer, a 1,3-beta-glucan/1,4-beta-glucan copolymer, a 1,3-beta-glucan/1,6-beta-glucan copolymer, or a mixture thereof.
Vaccine composition with FauA/BfeA/BhuR receptor-protein fragments and beta-glucan adjuvant
A vaccine composition comprising a Bordetella pertussis antigen and an effective adjuvant amount of a beta-glucan polymer, wherein the Bordetella pertussis antigen is selected from a fragment of siderophore receptor protein FauA selected from specified SEQ ID NOs, a fragment of xenosiderophore receptor protein BfeA selected from specified SEQ ID NOs, a fragment of hemophore receptor protein BhuR selected from specified SEQ ID NOs, and mixtures thereof.
Vaccine composition with specified FauA receptor-protein fragments and beta-glucan adjuvant
A vaccine composition comprising a Bordetella pertussis antigen, wherein the Bordetella pertussis antigen is selected from a fragment of siderophore receptor protein FauA selected from specified SEQ ID NOs, a fragment of xenosiderophore receptor protein BfeA selected from specified SEQ ID NOs, a fragment of hemophore receptor protein BhuR selected from specified SEQ ID NOs, and mixtures thereof.
The independent claims collectively require a pertussis-focused vaccine composition in which Bordetella pertussis antigens are combined with beta-glucan-based adjuvants, with baker’s yeast–derived beta-glucan polymers constrained by particle size in clm-00001 and clm-00002, and with receptor-protein fragments defined by specified SEQ ID NOs in clm-00018 and clm-00019.
Stated Advantages
Enhanced bacterial clearance.
Reduced lung inflammatory cytokines, including IL-6.
Induction of IL-17 and antibody responses including mucosal IgA.
Reduced bacterial burden and neutrophil recruitment.
Vaccine particle localization/retention in the upper airway versus lung.
Increased long-term antibody levels and bone marrow antibody-secreting cells.
Documented Applications
Intranasal pertussis vaccination using the disclosed vaccine compositions.
Use in a mice challenge context to assess bacterial clearance, lung inflammation, and immune responses.
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