# US 2023/0265129 A1 · Subunit Vaccine Composition For African Swine Fever, And Preparation Therefor And Use Thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0265129 A1 - Document ID: US20230265129A1 - Status: Published application - Kind: A1 - Application number: 18/005,367 - Filed: 2021-07-15 - Published: 2023-08-24 - Earliest claimed: 2020-07-15 - Assignees: Novo Biotech Corp. - Applicants: Novo Biotech Corp - Inventors: Qiang ZHANG; Hong QIAN; Youqiang WU; Sufang WU; Ying CHE - Web page: https://patentgrep.com/patent/US20230265129A1 ## CPC - C07K 14/01: DNA viruses - A61K 39/12: Viral antigens - A61P 31/20: for DNA viruses - C07K 14/005: from viruses - C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) - A61K 2039/552: {Veterinary vaccine} - A61K 2039/55522: {Cytokines; Lymphokines; Interferons} - A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59} - C12N 2710/12022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes - C12N 2710/12034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - 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 provides a subunit vaccine composition for African swine fever, and a preparation therefor and use thereof, which fall within the technical field of animal vaccines and veterinary biological products. The vaccine comprises an exterior envelope protein CD2V derived from African swine fever virus and an exterior envelope capsid protein p72 derived from African swine fever virus and a pharmaceutically acceptable adjuvant. The method for preparing the vaccine comprises: 1) preparing the exterior envelope protein CD2V derived from African swine fever virus and the exterior envelope capsid protein p72 derived from African swine fever virus; 2) mixing the exterior envelope protein CD2V derived from African swine fever virus with the exterior envelope capsid protein p72 derived from African swine fever virus prepared in step 1), so as to prepare an antigen solution; and 3) emulsifying the antigen solution and ISA 201 VG at a volume ratio of 46:54. ## Claims ### Claim 1 A subunit vaccine composition for African swine fever, wherein the vaccine composition comprises an exterior envelope subunit protein CD2V derived from African swine fever virus, an exterior envelope subunit protein p72 derived from African swine fever virus, and pharmaceutically acceptable adjuvant; wherein the exterior envelope subunit protein CD2V derived from African swine fever virus is a glycosylated protein expressed in the eukaryotic system, the exterior envelope subunit protein p72 derived from African swine fever virus is a trimeric protein. ### Claim 2 (depends on 1) The subunit vaccine composition for African swine fever according to claim 1, wherein the content of the trimeric protein is not less than 40% of the total amount of the exterior envelope subunit protein p72 derived from African swine fever virus. ### Claim 3 (depends on 1) The subunit vaccine composition for African swine fever according to claim 1, wherein the exterior envelope subunit protein CD2V derived from African swine fever virus is a glycosylated protein with antigenicity, and is at least a glycosylated protein expressed in the eukaryotic system selected from the group consisting of full-length proteins, fusion proteins fused with chaperone protein, truncated proteins, fusion proteins fused with chaperone protein and protein after truncated. ### Claim 4 (depends on 1) The subunit vaccine composition for African swine fever according to claim 1, wherein the exterior envelope subunit protein CD2V derived from African swine fever virus is mixed with the exterior envelope subunit protein p72 derived from African swine fever virus in a mass ratio of 1-8:8-1. ### Claim 5 (depends on 4) The subunit vaccine composition for African swine fever according to claim 4, wherein the exterior envelope subunit protein CD2V derived from African swine fever virus is mixed with the exterior envelope subunit protein p72 derived from African swine fever virus in equal mass ratio. ### Claim 6 (depends on 5) The subunit vaccine composition for African swine fever according to claim 5, wherein the concentration of the exterior envelope subunit protein CD2V derived from African swine fever virus and the exterior envelope subunit protein p72 derived from African swine fever virus are 25 μg/vaccine-200 μg/vaccine respectively. ### Claim 7 (depends on 6) The subunit vaccine composition for African swine fever according to claim 6, wherein the concentration of the exterior envelope subunit protein CD2V derived from African swine fever virus and the exterior envelope subunit protein p72 derived from African swine fever virus are 50 μg/vaccine respectively. ### Claim 8 (depends on 1) The subunit vaccine composition for African swine fever according to claim 1, wherein the pharmaceutically acceptable adjuvant is ISA 201 VG. ### Claim 9 (depends on 1) The subunit vaccine composition for African swine fever according to claim 1, wherein the vaccine composition further comprises an immunopotentiator and/or preservative. ### Claim 10 (depends on 9) The subunit vaccine composition for African swine fever according to claim 9, wherein the immunopotentiator is GM-CSF, the concentration of the GM-CSF is 20 μg/vaccine-60 μg/vaccine, preferably 40 μg/vaccine. ### Claim 11 (depends on 10) The subunit vaccine composition for African swine fever according to claim 10, wherein the preservative is thiomersalate, and the content of the thiomersalate is 2 μg/vaccine. ### Claim 12 (depends on 1) A method for preparing the vaccine composition according to claim 1, comprising the following steps: 1) preparing the exterior envelope subunit protein CD2V derived from African swine fever virus and the exterior envelope subunit protein p72 derived from African swine fever virus; wherein, the exterior envelope subunit protein CD2V derived from African swine fever virus is a glycosylated protein expressed in the eukaryotic system; the exterior envelope subunit protein p72 derived from African swine fever virus is a trimeric protein, and the content of the trimeric protein is not less than 40% of the total amount of the exterior envelope subunit protein p72 derived from African swine fever virus; 2) mixing the exterior envelope subunit protein CD2V derived from African swine fever virus with the exterior envelope subunit protein p72 derived from African swine fever virus prepared by step 1) to obtain an antigen solution; wherein, mixing the exterior envelope subunit protein CD2V derived from African swine fever virus with the exterior envelope subunit protein p72 derived from African swine fever virus in a mass ratio of 1-8:8-1; and 3) mixing the antigen solution with the ISA 201 VG in a volume ratio of 46:54 and then emulsifying to obtain a vaccine composition. ### Claim 13 (depends on 12) The method according to claim 12, wherein mixing the exterior envelope subunit protein CD2V derived from African swine fever virus with the exterior envelope subunit protein p72 derived from African swine fever virus in equal mass ratio. ### Claim 14 (depends on 12) The method according to claim 12, wherein in step 2), the antigen solution further comprises a preservative. ### Claim 15 (depends on 1) An application of the subunit vaccine composition for African swine fever according to claim 1 in preparation of a vaccine for preventing African swine fever virus infection.