Method for reducing zoonotic infectious diseases

Inventors

Zatechka, Douglas StevenKauffman, MasonPrzybyszewski, Chris

Assignees

US Biologic Inc

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Publication Number

US-11576868-B2

Patent

Publication Date

2023-02-14

Expiration Date


Abstract

The presently disclosed subject matter relates to a composition and method of using the composition for oral delivery of a bioactive agent to a subject. More particularly, the presently disclosed subject matter relates to a composition comprising an effective amount of at least one bioactive agent layered over a substrate and a method of reducing zoonotic infectious disease by administering the composition to a subject. The presently disclosed subject matter further relates to a method of preparing the composition.

Core Innovation

The invention relates to an oral, reservoir-targeted vaccination approach for Lyme disease control by orally administering to a subject a composition for oral delivery of a bait foodstuff. The bait foodstuff comprises a bait substrate having a surface, and at least one antigenic agent layered over the substrate, stabilized within a stabilizer under conditions facilitating anhydrobiosis.

The stabilized antigenic agent is characterized by the stabilizer being selected from at least one of a hydrocolloid polymer and a plasticizing sugar, complexed in solution with a phosphate-buffered saline liquid carrier. The composition further includes a calcium salt cross-linking agent configured to facilitate encapsulation of the antigenic agent within the stabilizer on the surface of the substrate.

In particular, the antigenic agent is a bacterial vehicle defined by a recombinant whole-cell OspA-vectored Escherichia coli engineered to express at least one Borrelia burgdorferi antigen. Documented embodiments include hydrocolloids such as sodium alginate and enteric or moisture/flavor barrier coatings such as shellac and confectionary glaze, together with a defined minimal immunizing dosage range expressed in CFU for the bacterial vehicle.

Claims Coverage

The independent claim coverage comprises 1 independent claim, which defines the core method of controlling Lyme disease by orally vaccinating a subject using a bait foodstuff with a layered and anhydrobiosis-stabilized bacterial antigen encapsulated by calcium-salt cross-linking. The remaining claims refine the independent claim by specifying particular stabilizer and cross-linker selections, quantitative amounts, and contextual delivery/vehicle formats.

Oral bait foodstuff vaccination with anhydrobiosis-facilitating stabilized bacterial vehicle

A method of controlling Lyme disease by orally administering to a subject a bait foodstuff comprising a bait substrate; an antigenic agent layered over the substrate, stabilized within a stabilizer under conditions facilitating anhydrobiosis, the stabilizer selected from a hydrocolloid polymer and a plasticizing sugar complexed with a phosphate-buffered saline liquid carrier; and a calcium salt cross-linking agent facilitating encapsulation of the antigenic agent within the stabilizer on the substrate surface, wherein the antigenic agent is a bacterial vehicle defined by a recombinant whole-cell OspA-vectored Escherichia coli engineered to express at least one Borrelia burgdorferi antigen.

Overall, the claim coverage centers on an oral bait foodstuff vaccination method in which an OspA-vectored recombinant whole-cell bacterial vehicle expressing Borrelia burgdorferi antigens is layered onto a bait substrate, stabilized in an anhydrobiosis-facilitating stabilizer matrix, and encapsulated via calcium salt cross-linking on the substrate surface, with dependent claims narrowing stabilizer and cross-linker selections, dosage, and bait composition parameters.

Stated Advantages

Enables an oral, reservoir-targeted vaccination approach for Lyme disease control using bait foodstuff.

Provides stabilization under conditions facilitating anhydrobiosis via a stabilizer matrix, with calcium-salt cross-linking to encapsulate the antigenic agent on the bait substrate surface.

Supports defined immunogenically effective antigen dosing expressed as a minimal immunizing dosage (MID) in CFU.

Documented Applications

Controlling Lyme disease by vaccinating a subject in need thereof.

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