Immunogenic compositions for treatment of Hepatitis B
Inventors
Anderson, David Evander • Ahmed, Tanvir
Assignees
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Publication Number
US-12128100-B2
Publication Date
2024-10-29
Expiration Date
Abstract
The present disclosure provides compositions and methods useful for inducing a The cell response in a subject suffering from Hepatitis B. As described herein, the compositions of the disclosure comprise HBsAg having S, Pre-S1 and Pre-S2 proteins and an aluminum phosphate adjuvant. In a preferred embodiment, the immunogenic composition comprises at least 20 μg/ml of HBsAg antigen and the amount of non-adsorbed antigen is at least 30%.
Core Innovation
The invention relates to a therapeutic Hepatitis B immunogenic composition comprising HBsAg envelope antigens containing S, Pre-S1, and Pre-S2 proteins formulated with an aluminum phosphate adjuvant. The composition is characterized by comprising at least 20 μg/ml of HBsAg antigen and by having an amount of non-adsorbed antigen that is at least 30%.
The document emphasizes formulation features for aluminum phosphate that achieve an elevated non-adsorbed/free antigen fraction, including comparison against aluminum hydroxide formulations. Aluminum phosphate compositions are contrasted with aluminum hydroxide adjuvant formulations that show markedly lower free/non-adsorbed antigen.
The invention is supported by immunological findings described in the document, including enhanced Th1-cell responses such as IFN-γ ELISPOT and IgG2a/IgG1 ratios. The aluminum phosphate formulations are described as increasing Th1 activity in comparison settings and are positioned as a pharmaceutical composition for inducing or enhancing Th1 responses and for treating chronic Hepatitis B.
Claims Coverage
The independent claim covers an immunogenic composition and its key formulation constraints, namely the HBsAg antigen composition (S, Pre-S1, Pre-S2) with an aluminum phosphate adjuvant, together with quantitative limits on total HBsAg antigen (at least 20 μg/ml) and non-adsorbed antigen (at least 30%). The document also describes additional claim coverage for specific quantitative refinements and for downstream therapeutic and immunological use.
HBsAg antigen with aluminum phosphate and non-adsorbed antigen threshold
An immunogenic composition comprising an HBsAg antigen comprising S protein, Pre-S1 protein and Pre-S2 protein, and an aluminum phosphate adjuvant, wherein the composition comprises at least 20 μg/ml of HBsAg antigen and the amount of non-adsorbed antigen is at least 30%.
Specific aluminum concentration for aluminum phosphate formulation
The immunogenic composition comprises aluminum at a concentration of 500 μg/ml.
Specific HBsAg antigen concentration
The immunogenic composition includes the HBsAg antigen at a concentration of 20 μg/ml.
Pharmaceutical composition with pharmaceutically acceptable excipient
A pharmaceutical composition includes the immunogenic composition together with a pharmaceutically acceptable excipient.
Method inducing Th1 cell response by administering the immunogenic composition
A method for inducing a Th1 cell immune response in a mammal by administering the immunogenic composition.
Combination with additional Hepatitis B treatment agent types
The method further specifies that the additional Hepatitis B treatment is either a nucleoside inhibitor or a pegylated interferon alpha.
Overall, the claim coverage is centered on a therapeutic Hepatitis B immunogenic composition defined by HBsAg S/Pre-S1/Pre-S2 antigens with an aluminum phosphate adjuvant and a non-adsorbed antigen threshold while maintaining at least 20 μg/ml HBsAg. Dependent coverage refines quantitative formulation parameters, adds pharmaceutically acceptable excipients, and extends to inducing Th1-cell responses and treating Hepatitis B, including combinations with nucleoside inhibitors or pegylated interferon alpha.
Stated Advantages
Enhanced Th1-cell responses, including increased IFN-γ ELISPOT and IgG2a/IgG1 ratio outcomes compared with aluminum hydroxide settings.
Increased Th1 activity for aluminum phosphate formulations that achieve elevated non-adsorbed/free antigen, supported by head-to-head comparison against a commercial aluminum-hydroxide prophylactic vaccine.
Documented Applications
A therapeutic Hepatitis B immunogenic composition for inducing or enhancing Th1 responses.
Use as a pharmaceutical composition for treating chronic Hepatitis B.
Use in combination with conventional Hepatitis B treatment approaches, including nucleoside inhibitors or pegylated interferon alpha.
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