Immunogenic composition forming a vaccine, and a method for its manufacture
Inventors
Mosharraf, Mitra • Sorayya, Aryo • Nayar, Rajiv
Assignees
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Publication Number
US-11559577-B2
Publication Date
2023-01-24
Expiration Date
Abstract
An immunogenic composition forming a vaccine includes a nanoparticle delivery system comprising at least a nanoparticle, wherein the at least a nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including a positively charged amino group head and at least a carbon tail and an antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a nucleic acid encoding a protein from a coronavirus.
Core Innovation
The invention relates to an immunogenic composition forming a vaccine, comprising a nanoparticle delivery system with a lipid layer exterior. The lipid layer includes dipalmitoyl phosphatidylcholine (DPPC), dioleoylphosphatidylcholine (DOPC), cholesterol, and a primary alkyl amine having a positively charged amino group head and a carbon tail, with a DPPC: DOPC: cholesterol: alkyl amine molar ratio of 20-40:15-30:20-10-45.
The composition further includes an antigen incorporated in the nanoparticle. The antigen comprises a nucleic acid encoding at least a part of a spike protein, where the spike protein includes a SARS-CoV-2 S2 protein.
The antigen is combined with the nanoparticle delivery system by lyophilizing the at least a nanoparticle and reconstituting the at least a nanoparticle using a solution containing the antigen.
Claims Coverage
The partial content provides one independent claim that focuses on a vaccine-forming immunogenic composition combining a defined lipid-layer nanoparticle with a nucleic-acid spike antigen, with antigen combination via lyophilization and reconstitution. The independent claim includes three main inventive aspects.
Lipid-layer nanoparticle delivery system with defined lipid composition
A nanoparticle delivery system in which at least a nanoparticle comprises a lipid layer exterior including DPPC, DOPC, cholesterol, and a primary alkyl amine with a positively charged amino group head and at least a carbon tail, with a DPPC: DOPC: cholesterol: alkyl amine molar ratio of 20-40:15-30:20-10-45.
Nucleic-acid encoded SARS-CoV-2 spike S2 antigen incorporated in the nanoparticle
An antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a nucleic acid encoding at least a part of a spike protein that includes a SARS-CoV-2 S2 protein.
Lyophilizing nanoparticles and reconstituting with antigen-containing solution
Antigen is combined with the nanoparticle delivery system by lyophilizing the at least a nanoparticle and reconstituting the at least a nanoparticle using a solution containing the antigen.
Across the independent claim, the coverage centers on combining a defined DPPC/DOPC/cholesterol/primary alkyl amine lipid-layer nanoparticle with a nucleic-acid encoding a SARS-CoV-2 spike protein including S2, where antigen is incorporated into the product by lyophilizing the nanoparticles followed by reconstituting with an antigen-containing solution.
Stated Advantages
Documented Applications
Not explicitly described in patent.
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