Title:
VACCINE FOR NOVEL CORONAVIRUS SARS-COV-2 DELTA VARIANT AND APPLICATION
Document Type and Number:
WIPO Patent Application WO/2023/036191
Kind Code:
A1
Abstract:
A vaccine for a novel coronavirus SARS-CoV-2 Delta variant and an application, the vaccine comprising a fusion protein, and the fusion protein comprising: (1) an interferon or a functional fragment thereof; (2) a novel coronavirus SARS-CoV-2 delta strain S protein or a functional fragment thereof; and (3) an immunoglobulin Fc region. The vaccine can improve the immunogenicity and neutralizing antibody titer for mutant novel coronavirus antigens by means of the fusion-expressed IFN; it ensures efficient production of neutralizing antibodies, and can significantly improve the defense against mutant strains.
Inventors:
LIN JINGJING (CN)
CHEN XI (CN)
SUN YIFEI (CN)
HU ZHENXIANG (CN)
YANG JIAMING (CN)
CHEN XI (CN)
SUN YIFEI (CN)
HU ZHENXIANG (CN)
YANG JIAMING (CN)
Application Number:
PCT/CN2022/117601
Publication Date:
March 16, 2023
Filing Date:
September 07, 2022
Export Citation:
Assignee:
LIVZON MABPHARM INC (CN)
International Classes:
C07K19/00; A61K39/215; A61P31/14; C07K14/165; C07K14/56; C12N15/62
Domestic Patent References:
| WO2004094454A2 | 2004-11-04 | |||
| WO2021160346A1 | 2021-08-19 |
Other References:
SUN SHIYU, CHEN XI, LIN JINGJING, AI JUNWEN, YANG JIAMING, HU ZHENXIANG, FU YANG-XIN, PENG HUA: "Broad neutralization against SARS-CoV-2 variants induced by a next-generation protein vaccine V-01", CELL DISCOVERY, vol. 7, no. 1, XP093046925, DOI: 10.1038/s41421-021-00350-6
SONG SHUO, ZHOU BING, CHENG LIN, LIU WEILONG, FAN QING, GE XIANGYANG, PENG HUA, FU YANG-XIN, JU BIN, ZHANG ZHENG: "Sequential immunization with SARS-CoV-2 RBD vaccine induces potent and broad neutralization against variants in mice", VIROLOGY JOURNAL, vol. 19, no. 1, 1 December 2022 (2022-12-01), XP093046924, DOI: 10.1186/s12985-021-01737-3
ZHANG ZHIREN, HE QIAREN, ZHAO WEI, LI YONG, YANG JIAMING, HU ZHENXIANG, CHEN XI, PENG HUA, FU YANG-XIN, CHEN LONG, LU LIGONG: "A Heterologous V-01 or Variant-Matched Bivalent V-01D-351 Booster following Primary Series of Inactivated Vaccine Enhances the Neutralizing Capacity against SARS-CoV-2 Delta and Omicron Strains", JOURNAL OF CLINICAL MEDICINE, vol. 11, no. 14, 1 January 2022 (2022-01-01), pages 4164, XP093046923, DOI: 10.3390/jcm11144164
SUN, SHIYU ET AL.: "Interferon-armed RBD dimer enhances the immunogenicity of RBD for sterilizing immunity against SARS-CoV-2", CELL RESEARCH, vol. 31, 15 July 2021 (2021-07-15), XP037566854, DOI: 10.1038/s41422-021-00531-8
MLCOCHOVA, P. ET AL.: "SARS-CoV-2 B.1.617.2 Delta variant replication and immune evasion", NATURE, vol. 599, 6 September 2021 (2021-09-06), XP037607898, DOI: 10.1038/s41586-021-03944-y
SHU YA-JUN, HE JIAN-FENG, PEI RONG-JUAN, HE PENG, HUANG ZHU-HANG, CHEN SHAO-MIN, OU ZHI-QIANG, DENG JING-LONG, ZENG PEI-YU, ZHOU J: "Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial", CHINESE MEDICAL JOURNAL / ZHONGHUA YIXUE ZAZHI YINGWEN BAN., CHINESE MEDICAL ASSOCIATION, BEIJING., CN, vol. 134, no. 16, 1 January 2021 (2021-01-01), CN , pages 1967 - 1976, XP093046922, ISSN: 0366-6999, DOI: 10.1097/CM9.0000000000001702
SHI QINGFENG, GAO XIAO-DONG; HU BI-JIE: "Research progress on characteristics, epidemiology and control measure of SARS-CoV-2 Delta VOC", ZHONG HUA YI YUAN GAN RAN XUE ZA ZHI= CHINESE JOURNAL OF NOSOCOMICOLOGY, XX, CN, vol. 31, no. 24, 8 July 2021 (2021-07-08), CN , pages 3703 - 3707, XP093046918, ISSN: 1005-4529, DOI: 10.11816/cn.ni.2021-211664
LIU ZEZHONG, ET AL: "RBD-Fc-based COVID-19 vaccine candidate induces highly potent SARS-CoV-2 neutralizing antibody response", SIGNAL TRANSDUCTION AND TARGETED THERAPY, vol. 5, no. 1, 1 December 2020 (2020-12-01), pages 1 - 10, XP055950023, DOI: 10.1038/s41392-020-00402-5
LIU, XINXUE ET AL.: "Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial", LANCET, vol. 398, 6 August 2021 (2021-08-06), XP086763578, DOI: 10.1016/S0140-6736(21)01694-9
BARROS-MARTINS, J. ET AL.: "Immune responses against SARS-CoV-2 variants after heterologous and homologous ChAdOx1nCoV-19/BNT162b2 vaccination", NATURE MEDICINE, vol. 27, 14 July 2021 (2021-07-14), XP037562946, DOI: 10.1038/s41591-021-01449-9
DATABASE PROTEIN ANONYMOUS : "Surface glycoprotein, partial [Severe acute respiratory syndrome coronavirus 2]", XP093046916, retrieved from NCBI
SONG SHUO, ZHOU BING, CHENG LIN, LIU WEILONG, FAN QING, GE XIANGYANG, PENG HUA, FU YANG-XIN, JU BIN, ZHANG ZHENG: "Sequential immunization with SARS-CoV-2 RBD vaccine induces potent and broad neutralization against variants in mice", VIROLOGY JOURNAL, vol. 19, no. 1, 1 December 2022 (2022-12-01), XP093046924, DOI: 10.1186/s12985-021-01737-3
ZHANG ZHIREN, HE QIAREN, ZHAO WEI, LI YONG, YANG JIAMING, HU ZHENXIANG, CHEN XI, PENG HUA, FU YANG-XIN, CHEN LONG, LU LIGONG: "A Heterologous V-01 or Variant-Matched Bivalent V-01D-351 Booster following Primary Series of Inactivated Vaccine Enhances the Neutralizing Capacity against SARS-CoV-2 Delta and Omicron Strains", JOURNAL OF CLINICAL MEDICINE, vol. 11, no. 14, 1 January 2022 (2022-01-01), pages 4164, XP093046923, DOI: 10.3390/jcm11144164
SUN, SHIYU ET AL.: "Interferon-armed RBD dimer enhances the immunogenicity of RBD for sterilizing immunity against SARS-CoV-2", CELL RESEARCH, vol. 31, 15 July 2021 (2021-07-15), XP037566854, DOI: 10.1038/s41422-021-00531-8
MLCOCHOVA, P. ET AL.: "SARS-CoV-2 B.1.617.2 Delta variant replication and immune evasion", NATURE, vol. 599, 6 September 2021 (2021-09-06), XP037607898, DOI: 10.1038/s41586-021-03944-y
SHU YA-JUN, HE JIAN-FENG, PEI RONG-JUAN, HE PENG, HUANG ZHU-HANG, CHEN SHAO-MIN, OU ZHI-QIANG, DENG JING-LONG, ZENG PEI-YU, ZHOU J: "Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial", CHINESE MEDICAL JOURNAL / ZHONGHUA YIXUE ZAZHI YINGWEN BAN., CHINESE MEDICAL ASSOCIATION, BEIJING., CN, vol. 134, no. 16, 1 January 2021 (2021-01-01), CN , pages 1967 - 1976, XP093046922, ISSN: 0366-6999, DOI: 10.1097/CM9.0000000000001702
SHI QINGFENG, GAO XIAO-DONG; HU BI-JIE: "Research progress on characteristics, epidemiology and control measure of SARS-CoV-2 Delta VOC", ZHONG HUA YI YUAN GAN RAN XUE ZA ZHI= CHINESE JOURNAL OF NOSOCOMICOLOGY, XX, CN, vol. 31, no. 24, 8 July 2021 (2021-07-08), CN , pages 3703 - 3707, XP093046918, ISSN: 1005-4529, DOI: 10.11816/cn.ni.2021-211664
LIU ZEZHONG, ET AL: "RBD-Fc-based COVID-19 vaccine candidate induces highly potent SARS-CoV-2 neutralizing antibody response", SIGNAL TRANSDUCTION AND TARGETED THERAPY, vol. 5, no. 1, 1 December 2020 (2020-12-01), pages 1 - 10, XP055950023, DOI: 10.1038/s41392-020-00402-5
LIU, XINXUE ET AL.: "Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial", LANCET, vol. 398, 6 August 2021 (2021-08-06), XP086763578, DOI: 10.1016/S0140-6736(21)01694-9
BARROS-MARTINS, J. ET AL.: "Immune responses against SARS-CoV-2 variants after heterologous and homologous ChAdOx1nCoV-19/BNT162b2 vaccination", NATURE MEDICINE, vol. 27, 14 July 2021 (2021-07-14), XP037562946, DOI: 10.1038/s41591-021-01449-9
DATABASE PROTEIN ANONYMOUS : "Surface glycoprotein, partial [Severe acute respiratory syndrome coronavirus 2]", XP093046916, retrieved from NCBI
Attorney, Agent or Firm:
MERITS IP LTD. (CN)
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