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    Home > Active Ingredient News > Infection > The clinical results of the recombinant protein subunit vaccine of the Gaofu academician team of the Institute of Microbiology officially released

    The clinical results of the recombinant protein subunit vaccine of the Gaofu academician team of the Institute of Microbiology officially released

    • Last Update: 2021-04-20
    • Source: Internet
    • Author: User
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    On March 24, the world-renowned medical journal "The Lancet-Infectious Diseases" reported the first phase of the recombinant protein subunit vaccine (ZF2001) developed by the team of Gao Fu from the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkema Biopharmaceutical Co.
    , Ltd.
    And Phase 2 clinical trial results (Yang et al, 2021, Lancet Infectious diseases).

    The test results show that the vaccine is safe and there are no serious adverse events related to the vaccine.
    97% of the participants who received 3 doses of 25μg vaccine produced neutralizing antibodies that can block the live virus, and the level of neutralizing antibodies exceeds that of recovered patients.
    serum.

    At present, there are many vaccines against COVID-19 in the world, but they still cannot meet people's demand for vaccination (Dai and Gao, 2021, Nature Reviews Immunology).

    Therefore, it is possible to effectively control the global spread of COVID-19 by developing vaccines on a large scale and diversification.

    Recombinant protein subunit vaccines have the advantages of high yield, high safety, easy storage and transportation, and are one of the important choices to prevent and block the spread of COVID-19.

    The ZF2001 vaccine is based on the previous dimer concept of the MERS coronavirus spike protein (S) receptor binding domain (RBD) (Dai et al, 2020, Cell).
    The new coronavirus RBD is designed to be a dimer (RBD- dimer) antigen, which successfully retained the efficacy of the vaccine, and the neutralizing antibody titer after immunization of mice was higher than that of monomer immunization.

    The two phases of clinical trials of the ZF2001 vaccine in China recruited 950 healthy adults between 18 and 59 years old.
    A randomized, double-blind, and placebo-controlled trial protocol was used.
    The trial was conducted in the Second Affiliated Hospital of Chongqing Medical University and Capital Medical University.
    Beijing Chaoyang Hospital and Hunan Xiangtan Center for Disease Control and Prevention were completed.

    The test evaluates the safety and immunogenicity of the vaccine, including adverse events and serious adverse events, antibody titers, neutralizing antibody titers, and seroconversion rate.

    The results show that the vaccine has good tolerance and immunogenicity.

    Most of the participants did not observe adverse reactions or mild or moderate adverse reactions, mainly red and swelling, pain at the injection site, itching, etc.
    , which are common reactions after recombinant protein vaccination.

    No serious vaccine-related adverse events occurred.

    After 2 doses of vaccine, 76% of people can produce neutralizing antibodies.

    After 3 doses of vaccine, 97% of people can produce neutralizing antibodies.

    The geometric mean antibody titer (GMT) reached 102.
    5, exceeding the serum neutralizing antibody level (GMT, 51) of 89 COVID-19 rehabilitation patients (Figure 1).

    In addition, the vaccine can produce a moderate and balanced Th1/Th2 cellular immune response.

    Figure 1: The new crown recombinant protein subunit vaccine ZF2001 produces neutralizing antibodies in subjects that are above the level of recovered patients.
    Phase 1 clinical (A) binding antibody positive conversion rate (B) binding antibody titer (C) neutralizing antibody positive conversion Rate (D) neutralizing antibody titer; Phase 2 clinical (E) binding antibody positive conversion rate (F) binding antibody titer (G) neutralizing antibody positive conversion rate (H) neutralizing antibody titer.

    In addition, in February this year, the Gao Fu team of the Chinese Center for Disease Control and Prevention released on bioRxiv partial results of the international phase 3 clinical trial, showing the neutralizing effect of the domestic recombinant protein subunit new crown vaccine ZF2001 on the new South African variant (501Y.
    V2) .

    The results showed that although the neutralizing effect of the vaccine's serum against the new South African variant was slightly reduced, it still retained most of the neutralizing activity, suggesting that the vaccine still has a protective effect on the new South African variant (Huang et al, 2021, BioRxiv) .

    However, due to the long-term epidemic and mutual recombination of animal-derived coronaviruses (Su et al, 2016, Trends in Microbiology), there is still a need to develop a universal coronavirus vaccine in the future.

    Currently, the vaccine is undergoing international multi-center phase 3 clinical trials in Uzbekistan, Indonesia, Pakistan and Ecuador, and was approved for registration in Uzbekistan on March 1, 2021.
    It is the world's first new crown recombinant protein vaccine approved for use.
    .

    The vaccine was also approved for emergency use in China on March 10, 2021.

    Yang Shilong of Anhui Zhifeilong Kema, Li Yan and Dai Lianpan of Institute of Microbiology, Chinese Academy of Sciences, Wang Jianfeng and He Peng of China Institute for Food and Drug Control are the co-first authors of the paper.

    Meng Shufang, Chinese Academy of Food and Drug Control, Yan Jinghua, Institute of Microbiology, Chinese Academy of Sciences, Hu Zhongyu, Chinese Academy of Food and Drug Control, Gao Lidong, Hunan Center for Disease Control and Prevention, and Gao Fu, Institute of Microbiology, Chinese Academy of Sciences, are the co-corresponding authors of the paper.

    This project is supported by the National Key Research and Development Program, the National Key Drug Research and Development Project of the Ministry of Science and Technology, the pilot project of the Chinese Academy of Sciences and the Anhui Zhifeilong Kema Biopharmaceutical Company.

    et al.
    Epidemiology, GeneticRecombination, and Pathogenesis of Coronaviruses.
    Trends Microbiol.
    2016Jun;24(6):490-502.
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