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Publication Number
US-10765735-B2
Publication Date
2020-09-08
Expiration Date
Abstract
This disclosure provides adjuvant compositions that are capable of modulating the immune response in a subject. These adjuvant compositions may also be used enhance the immunogenicity of antigens. Also provided are methods of making the adjuvant compositions as well as methods of using the adjuvant compositions.
Core Innovation
The invention provides adjuvant compositions for modulating immune responses and enhancing antigen immunogenicity. The compositions use a pharmaceutically acceptable vegetable oil carrier that includes mustard oil and optionally rubefacient oils and/or allyl isothiocyanate. The adjuvant is combined with flavonoids, including catechins such as catechin hydrate and epigallocatechin gallate (EGCG), together with vitamins including vitamin A, vitamin E, vitamin D, and/or vitamin C and optionally vitamin salts or derivatives.
The document further describes immunogenic compositions formed by combining an antigen with the adjuvant. The compositions are described as capable of being formulated for broad routes of administration, including mucosal and systemic routes. The document also describes optional formulation components such as emulsifiers, carriers, and particles, and concepts for making compositions by admixing.
Experimental examples are described to show immune response enhancement and immune balance effects with specific combinations, including catechin with mustard oil and/or vitamin A or vitamin E with mustard oil. Additional enhancement is described when allyl isothiocyanate is included together with vitamins and catechin, including regimens associated with intranasal/sublingual and combined administrations. Outcomes reported in the document include enhanced antibody titers, including IgG1, IgG2a, and IgA, together with cytokine and Th1-Th2/Treg balance (including IFN-b3, IL-5, and IL-10) for the described combinations.
Claims Coverage
The partial content includes two independent claims. One independent claim covers an adjuvant formulation that explicitly does not comprise an antigen, and the other independent claim covers an immunogenic composition that includes an antigen together with the defined adjuvant components; overall the claims cover 2 main inventive feature sets.
Oil plus catechin plus vitamin adjuvant without antigen
An adjuvant comprising a pharmaceutically acceptable oil selected from wintergreen oil, rosemary oil, mustard seed oil, allyl isothiocyanate, and a mixture thereof; at least one catechin; and at least one vitamin selected from vitamin A, vitamin E and vitamin D; wherein the adjuvant does not comprise an antigen.
Immunogenic composition with defined adjuvant including oil, catechin, and vitamin
An immunogenic composition comprising an adjuvant and an antigen, wherein the adjuvant comprises a pharmaceutically acceptable oil selected from wintergreen oil, rosemary oil, mustard seed oil, allyl isothiocyanate, and a mixture thereof; at least one catechin; and at least one vitamin selected from vitamin A, vitamin E and vitamin D.
Across the independent claims, the core coverage is directed to a defined adjuvant formulation containing a selected pharmaceutically acceptable oil plus catechin plus vitamin A/E/D with the explicit limitation that the adjuvant does not comprise an antigen, and an immunogenic composition in which the same defined adjuvant formulation is combined with an antigen.
Stated Advantages
Enhancing antigen immunogenicity.
Modulating immune responses.
Providing enhanced antibody titers (IgG1, IgG2a, and IgA) with the described combinations.
Inducing cytokine/Th1-Th2/Treg balance, including changes associated with IFN-b3, IL-5, and IL-10.
Documented Applications
Vaccination regimens are described with enhanced antibody titers (including IgG1, IgG2a, and IgA) and mucosal vaginal responses, using the described adjuvant and immunogenic composition combinations in the reported experimental examples.
Intranasal/sublingual and combined regimens are described in the document for the combinations including allyl isothiocyanate with vitamins and catechin, with reported immune outcomes.
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