Method for vaccination against a self-antigen in a human patient
Inventors
Galabova, Gergana • SCHMIDHUBER, Sabine • Schneeberger, Achim • Von Bonin, Arne • WINTER, Dorian • Zimmermann, Jana
Assignees
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Publication Number
US-12290553-B2
Publication Date
2025-05-06
Expiration Date
Abstract
Disclosed is a method for vaccination against a self-antigen in a human patient wherein a dose with an effective amount of a self-antigen is administered to the patient to elicit a primary immune response, characterised in that the patient is subjected to a boost administration of said self-antigen, wherein the amount of the self-antigen in the dose for the boost administration is higher than the amount of the self-antigen in the dose used in the administration for the primary immune response.
Core Innovation
The invention provides a method for vaccination against a self-antigen in a human patient by administering a dose with an effective amount of the self-antigen to elicit a primary immune response, followed by boost administration of the self-antigen. The approach is described as a self-antigen vaccination strategy intended to avoid T-cell activation/autoimmunity while driving B-cell responses, including IgG.
The boost administration uses a self-antigen amount that is at least 50 g and at least 200% higher than the amount of the self-antigen used in the dose for the primary immune response. The boost is administered at least 6 months after the first administration for eliciting the primary immune response, and the document further supports booster scheduling after the primary response has waned to reactivate memory and increase antibody titers.
Preferred self-antigens disclosed include proprotein convertase subtilisin/kexin type 9 (PCSK9) and alpha synuclein antigen, including aSyn mimotope-KLH such as AFFITOPEae PD01A. Mimotope/self-antigen sequences are identified using AFFITOMEae technology, and the document associates boosting with antibody responses and reports well tolerated boosting without clinical deterioration.
The document includes example clinical support for AFFITOPEae PD01A, including phase I priming followed by an approximately 115-week boost schedule, with reporting that aSyn-targeted antibodies are generated in a majority of vaccinated patients. It also describes preclinical and other example data involving antigens such as angiotensin II (AngII) and PCSK9, supporting dose-dependent boosting where a higher boost dose enhances re-boost antibody levels versus a low boost.
Claims Coverage
The independent claim defines a vaccination method featuring a timed boost, a relative dose increase for the boost over the primary dose, and the selection of specific self-antigens. The main claim coverage is grounded on three quantitative or conditional inventive elements: boost dose amount (50 g), boost dose relative increase (5200% vs primary dose), and boost timing (56 months after primary administration).
Boosted self-antigen vaccination schedule in a human patient
A method for vaccination against a self-antigen in a human patient wherein an effective amount of the self-antigen is administered to elicit a primary immune response and the patient is subjected to boost administration of the self-antigen.
Boost dose amount and relative increase versus primary dose
The boost administration uses a self-antigen amount that is at least 50 g and is at least 200% higher than the amount of the self-antigen in the dose used for the primary immune response.
Self-antigen selection for PCSK9 or alpha synuclein
The self-antigen is selected from the group consisting of proprotein convertase subtilisin/kexin type 9 (PCSK9) and an alpha synuclein antigen.
Boost timing at least 6 months after primary administration
The boost administration is administered at least 6 months after the first administration of the self-antigen for eliciting the primary immune response.
At least 12 months boost interval
In the method, the boost administration is administered at least 12 months after the initial self-antigen administration for eliciting the primary immune response.
Repeated boosting after at least one year with increased dose
The method includes repeating the boost administration after at least one year, wherein the repeated boost administration is at least 200% higher than the self-antigen amount used in the primary immune response dose.
Self-antigen polypeptide length coupled to a carrier
The self-antigen is a polypeptide of 7 to 30 amino acid residues coupled to a pharmaceutically acceptable carrier.
Co-administration with an adjuvant
The method is carried out by administering the self-antigen together with an adjuvant.
Specified administration routes
The self-antigen is administered by subcutaneous, intradermal, or intramuscular routes.
Across the independent claim and its dependent refinements, the core inventive coverage is a human self-antigen vaccination method where the boost is delivered after a minimum interval and uses a boost dose that is both at least 50 g and at least 200% higher than the primary dose, applied to self-antigens selected from PCSK9 and alpha synuclein antigen, with further refinement to antigen format, coupling to a carrier, co-administration with an adjuvant, and specified administration routes.
Stated Advantages
Avoidance of T-cell activation/autoimmunity while driving B-cell responses (IgG) is described in the document framing.
Boosting is reported as reactivating memory and increasing antibody titers.
Boosting is reported as well tolerated.
No clinical deterioration is reported in connection with boosting in the document.
Antibody generation is reported for aSyn-targeted antibodies in a majority of vaccinated patients.
Documented Applications
Human self-antigen vaccination against PCSK9 and alpha synuclein antigen, including approaches using AFFITOPEae PD01A (aSyn mimotope-KLH) as supported by phase I priming and a long-term boost schedule.
Use of AFFITOMEae technology to identify mimotope/self-antigen sequences for self-antigen vaccination approaches.
Preclinical and other example use supporting dose-dependent boosting for antigens including angiotensin II (AngII) and PCSK9, where a higher boost dose enhances re-boost antibody levels versus a low boost.
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