# US 2023/0272015 A1 · Vaccine composition for preventing severe acute respiratory syndrome coronavirus 2 infection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0272015 A1 - Document ID: US20230272015A1 - Status: Published application - Kind: A1 - Application number: 18/016,666 - Filed: 2021-07-19 - Published: 2023-08-31 - Earliest claimed: 2020-07-17 - Assignees: Geneone Life Science, Inc.; Korea Disease Control and Prevention Agency - Applicants: Geneone Life Science, Inc.; Korea Disease Control and Prevention Agency - Inventors: Young Keun Park; Byung Mun Cho; Moon Sup Jeong; Hyo Jin Lee; Song Yion Yeu; Young Ran Cho; Bo Yeong Park; Areum Gil; Bo Hyun Jeon; Ye Eun Oh; Gee Ho Park; Joel Maslow; Christine Claire Roberts; Mi Young KIM; Jung Ah Lee; Hee Ji Lim; Yun Ho Hwang - Web page: https://patentgrep.com/patent/US20230272015A1 ## CPC - C07K 14/005: from viruses - C07K 14/165: Coronaviridae, e.g. avian infectious bronchitis virus - A61K 39/12: Viral antigens - A61P 31/14: for RNA viruses - C12N 15/85: for animal cells - A61K 2039/53: {DNA (RNA) vaccination} - A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers} - A61K 2039/575: {humoral response} - C12N 2770/20022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes - C12N 2770/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - C12N 2800/22: Vectors comprising a coding region that has been codon optimised for expression in a respective host - C12N 2840/20: translation of more than one cistron - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract The present invention relates to a vaccine composition for preventing severe acute respiratory syndrome coronavirus 2 infection. The vaccine composition for preventing severe acute respiratory syndrome coronavirus 2 infection according to the present invention comprises spike and ORF3a or nucleocapsid as an antigen against SARS-CoV-2. The vaccine composition has a significant effect of inducing antibody immune responses and T-cell immune responses by a plurality of co-expressed antigens compared to those comprising one antigen, and thus can be variously used in the field of prevention of severe acute respiratory syndrome coronavirus 2 infection. ## Claims ### Claim 1 A method for preventing severe acute respiratory syndrome coronavirus 2 infection comprising treating a composition for preventing severe acute reparatory syndrome coronavirus 2 infection to a subject: wherein the composition comprises (a) a SARS-CoV-2 Spike protein or a gene encoding the SARS-CoV-2 Spike protein; and (b) a SARS-CoV-2 ORF3a protein or a gene encoding the SARS-CoV-2 ORF3a; or a SARS-CoV-2 nucleocapsid or a gene encoding the SARS-CoV-2 nucleocapsid. ### Claim 2 (canceled) ### Claim 3 (depends on 1) The method of claim 1, wherein the gene encoding the Spike, ORF3a or nucleocapsid protein is optimized with human codons. ### Claim 4 (depends on 3) The method of claim 3, wherein the gene encoding the Spike protein is represented by a nucleotide sequence of SEQ ID NO: 1 or 3. ### Claim 5 (depends on 3) The method of claim 3, wherein the gene encoding the ORF3a protein is represented by a nucleotide sequence of SEQ ID NO: 2. ### Claim 6 (depends on 3) The method of claim 3, wherein the gene encoding the nucleocapsid protein is represented by a nucleotide sequence of SEQ ID NO: 4. ### Claim 7 (depends on 1) The method of claim 1, wherein (a) the gene encoding the Spike protein; and (b) the gene encoding ORF3a or nucleocapsid protein are included in a bicistronic expression vector. ### Claim 8 (depends on 1) The method of claim 1, wherein the composition is for two doses. ### Claim 9 (canceled) ### Claim 10 (canceled) ### Claim 11 A bicistronic expression cassette comprising: (a) a gene encoding a SARS-CoV-2 Spike protein; and (b) a gene encoding a SARS-CoV-2 ORF3a protein; or a gene encoding a SARS-CoV-2 nucleocapsid protein. ### Claim 12 (depends on 11) The bicistronic expression cassette of claim 11, wherein the gene encoding the Spike, ORF3a or nucleocapsid protein is optimized with human codons. ### Claim 13 (depends on 12) The bicistronic expression cassette of claim 12, wherein the gene encoding the Spike protein is represented by a nucleotide sequence of SEQ ID NO: 1 or 3. ### Claim 14 (depends on 12) The bicistronic expression cassette of claim 12, wherein the gene encoding the ORF3a protein is represented by a nucleotide sequence of SEQ ID NO: 2. ### Claim 15 (depends on 12) The bicistronic expression cassette of claim 12, wherein the gene encoding the nucleocapsid protein is represented by a nucleotide sequence of SEQ ID NO: 4. ### Claim 16 (depends on 11) The bicistronic expression cassette of claim 11, further comprising: one or more components selected from the group consisting of a CMV promoter, a Kozak sequence, an IgE leader sequence, a furin recognition site, a GSG-T2A cleavage site, a BGH polyadenylation signal, a kanamycin resistance gene and a pUC origin. ### Claim 17 (depends on 16) The bicistronic expression cassette of claim 16, wherein the bicistronic expression cassette is represented by the following cleavage map. ### Claim 18 (depends on 11) A method for preventing severe acute respiratory syndrome coronavirus 2 infection comprising treating the bicistronic expression cassette according to claim 11 to a subject. ### Claim 19 (canceled) ### Claim 20 (depends on 18) The method of claim 18, wherein the bicistronic expression cassette is administered by at least one selected from the group consisting of intramuscular, intravenous, subcutaneous, intradermal and intranasal routes. ### Claim 21 (depends on 18) The method of claim 18, wherein the bicistronic expression cassette is administered by at least one method selected from the group consisting of electroporation, gene gun, and jet injection. ### Claim 22 (depends on 18) The method of claim 18, wherein the composition is administered intramuscularly through electroporation. ### Claim 23 (depends on 18) The method of claim 18, wherein the composition is administered through a liposome-mediated delivery method. ### Claim 24 (canceled) ### Claim 25 (depends on 1) The method of claim 1 wherein the composition is a vaccine composition or an immunogenic composition.