Periodontitis vaccine and related compositions and methods of use
Inventors
Assignees
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Publication Number
US-11701414-B2
Publication Date
2023-07-18
Expiration Date
Abstract
An immunogenic composition, a periodontal vaccine formulation containing the immunogenic composition, and methods for treating or preventing periodontal disease are provided, where the methods involves administering an immunologically effective amount of the composition or vaccine formulation to a subject. The immunogenic composition contains at least one polypeptide that comprises: an Mfa1 antigen sequence that is substantially homologous to an immunogenic amino acid sequence from an Mfa1 fimbrilin protein of a Porphyromonas bacterium; and an HA1 antigen sequence, an HA2 antigen sequence, or both an HA1 antigen sequence and an HA2 antigen sequence, wherein the HA1 antigen sequence is substantially homologous to an immunogenic amino acid sequence from an RgpA Gingipain hemagglutinin domain 1 contained within an RgpA Gingipain protein of a Porphyromonas bacterium, and the HA2 antigen sequence is substantially homologous to an immunogenic amino acid sequence from an RgpA Gingipain hemagglutinin domain 2 contained within an RgpA Gingipain protein of a Porphyromonas bacterium.
Core Innovation
The invention relates to a periodontitis vaccine based on an immunogenic composition containing an Mfa1 antigen sequence and one or more HA antigen sequences. The immunogenic composition includes at least one recombinant polypeptide comprising an Mfa1 antigen sequence and an HA1 antigen sequence, an HA2 antigen sequence, or both an HA1 antigen sequence and an HA2 antigen sequence.
The Mfa1 antigen sequence is described as having at least 90% sequence homology to a specified sequence, and the HA1 and HA2 antigen sequences are described as having at least 80% sequence homology to specified sequences. The immunogenic composition is described in the context of substantially homologous Porphyromonas antigens, where the HA1 and HA2 antigen sequences correspond to Gingipain hemagglutinin domains 1 and 2, and the Mfa1 antigen sequence corresponds to fimbrilin (Mfa1).
The vaccine antigen can be provided in antigen formats that include fusion polypeptide(s) and/or separate polypeptides, and is provided as a periodontal vaccine formulation with pharmaceutically acceptable excipients. The document further describes uses for treating and preventing periodontal disease in subjects, including periodontitis.
Claims Coverage
The independent claim recites an immunogenic composition defined by a recombinant polypeptide containing three specified antigen sequence components with defined sequence homology thresholds, including Mfa1 and HA1 and/or HA2. The claim set therefore covers an immunogenic composition architecture with defined antigen sequence homology constraints.
Recombinant polypeptide with Mfa1 and HA antigen sequence homology thresholds
An immunogenic composition comprising at least one recombinant polypeptide in which the at least one polypeptide comprises an Mfa1 antigen sequence with at least 90% sequence homology to SEQ ID NO: 4, and an HA1 antigen sequence and/or an HA2 antigen sequence, where the HA1 antigen sequence comprises at least 80% sequence homology to SEQ ID NO: 5 and the HA2 antigen sequence comprises at least 80% sequence homology to SEQ ID NO: 6.
Mfa1 with selected HA1/HA2 antigen sequence combination
A recombinant polypeptide that includes an Mfa1 antigen sequence combined with either an HA1 antigen sequence, an HA2 antigen sequence, or both an HA1 antigen sequence and an HA2 antigen sequence.
Across the independent claim scope, the key inventive coverage is defined by the inclusion of an Mfa1 antigen sequence together with HA1 and/or HA2 antigen sequences in a recombinant polypeptide, constrained by specified sequence homology thresholds to SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6.
Stated Advantages
Protection against oral bone loss in an oral challenge model.
Comparable protection with the combined protein vaccine regardless of adjuvant selection.
Documented Applications
Treating or preventing periodontal disease in subjects using the immunogenic composition.
Reducing or protecting against oral bone loss associated with periodontal disease after oral challenge.
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