Methods of making and using universal centralized influenza vaccine genes
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Publication Number
US-12064478-B2
Publication Date
2024-08-20
Expiration Date
Abstract
This document describes a number of different polypeptide sequences, and the nucleic acid sequences encoding such polypeptide sequences, that can be used alone or in combination as universal vaccines against viruses including influenza A or influenza B in humans or influenza in swine.
Core Innovation
The invention provides universal influenza vaccine genes and vaccine immunogens for influenza. Computational strategies generate centralized vaccine genes designed to localize to phylogenetic tree centers or clusters to reduce sequence divergence, including Centralized Consensus (COT/CC), Consensus of Unique Sequences (COUS), Mosaic vaccine immunogens, and Epigraph vaccine immunogens. The vaccine immunogens target potential T and B cell epitopes using the centralized computational design approaches.
The disclosure includes vaccine polypeptides and nucleic acids defined by sequence identity to specific SEQ ID sets. The vaccine polypeptides are described as having at least 90% sequence identity to amino acid sequences selected from SEQ ID NOs: 21, 22, 87 and 88, and are encoded by nucleic acids having at least 90% sequence identity to nucleic acid sequences selected from SEQ ID NOs: 111, 112, 121 and 122. A sequence/identity scope is provided across vaccine polypeptides and nucleic acids with specified identity ranges.
The invention further discloses vaccine compositions and delivery vehicles for administering the centralized influenza vaccine genes. Delivery vehicle options include viruses, pharmaceutically acceptable carriers, and nanoparticles, including lipid nanoparticles. The disclosure also describes vaccinating humans or swine and optionally repeating administration more than once, together with immunogenicity and challenge concepts to assess immune responses and protection.
Claims Coverage
The partial claim set includes one independent claim. Across this independent claim, the inventive coverage is centered on vaccine polypeptides and nucleic acids defined by sequence identity to specific SEQ ID NOs, and on how dependent claims narrow delivery vehicle type and vaccination context.
Sequence-identity-defined vaccine polypeptide and encoded nucleic acid
A vaccine polypeptide having at least 90% sequence identity to an amino acid sequence selected from SEQ ID NOs: 21, 22, 87 and 88, wherein the polypeptide is encoded by a nucleic acid sequence having at least 90% sequence identity to a nucleic acid sequence selected from SEQ ID NOs: 111, 112, 121 and 122, respectively.
Tightened sequence identity thresholds for polypeptides and nucleic acids
A vaccine polypeptide having at least 95% sequence identity to one of the amino acid sequences designated by SEQ ID NOs: 21, 22, 87, or 88, and encoded by a nucleic acid having at least 95% sequence identity to one of the specified nucleic acid sequences (SEQ ID NOs: 111, 112, 121, and 122).
Virus delivery vehicle vaccine composition
A vaccine composition where the delivery vehicle is a virus.
Specified viral delivery vehicle types
A vaccine composition in which the delivery vehicle virus is chosen from adenovirus, adeno-associated virus, retrovirus, alphavirus, paramyxovirus, or rhabdovirus.
Overall, the claims coverage in the provided material is directed to universal influenza vaccine polypeptides and encoded nucleic acids defined by sequence identity to named SEQ ID NOs, with dependent coverage narrowing identity thresholds, specifying virus-based delivery vehicles, and extending to vaccination contexts that can include repeated administration more than once.
Stated Advantages
Reduced sequence divergence and superior cross-protection are reported for centralized H1-COT in mouse challenge models.
High survival is reported across multiple divergent lethal challenges for multivalent centralized HA strategies compared with FluMist/FluZone.
Documented Applications
Use of the centralized influenza vaccine genes and vaccine compositions for vaccinating humans or swine, with optional repeated administration more than once.
Preclinical evaluation concepts including immunogenicity readouts and challenge models with reported outcomes such as weight loss and survival in mouse challenge models.
Evaluation frameworks described to include adenovirus expression, mRNA-LNP platform for human antigens, adenoviral vector expression/Western blot, and ferret evaluation.
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