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    Home > Medical News > Medical Science News > GSK adjuvant recombinant new crown vaccine enters Phase 3 clinical trials

    GSK adjuvant recombinant new crown vaccine enters Phase 3 clinical trials

    • Last Update: 2021-05-31
    • Source: Internet
    • Author: User
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    On May 27, local time, GlaxoSmithKline (GSK) announced that it has launched a phase 3 clinical trial of the adjuvant recombinant COVID-19 candidate vaccine developed in cooperation with Sanofi (SNF), which is expected to be in the United States, Asia, and Africa.
    More than 35,000 adult volunteers were enrolled in many regions such as Latin America.


    10 days ago, GSK just announced the Phase 2 clinical study data of this COVID-19 vaccine candidate, evaluating the immunogenicity of the two doses of the vaccine in 722 healthy volunteers 18 years and older.
    The results showed that the seroconversion rate of volunteers after the second dose of vaccination was 95%-100%, and after the completion of a single dose of vaccine, subjects who had been infected with SARS-CoV-2 also had high levels of seroconversion.
    The neutralizing antibody shows that the vaccine has a strong potential as a booster vaccine.


    The primary endpoint of this newly launched Phase 3 clinical study is the effectiveness of two doses of vaccine to prevent symptomatic COVID-19, and the secondary endpoint is the effectiveness of preventing severe COVID-19 and asymptomatic infections.
    The research will be carried out in two stages.
    First, the effectiveness of two doses of vaccine against the original D.
    614 strain will be studied, and then the effectiveness of the vaccine against the South African mutant strain B.
    1.
    351 will be explored.


    In addition, GSK and SNF will also explore the possibility of this vaccine as a booster vaccine in the next few weeks, which may create a larger market for this vaccine.


    According to GSK, the vaccine will be approved by the U.
    S.
    Food and Drug Administration (FDA) in the fourth quarter of 2021, and GSK and Sanofi will start production within a few weeks of obtaining the approval.


    It is worth noting that this vaccine of GSK and Sanofi encountered a major "crisis" in December 2020.
    Interim data from the Phase 1/2 study showed that the immune response of the vaccine did not meet expectations in the elderly.
    At that time, two pharmaceutical companies believed that this might be due to insufficient antigen concentration.
    Judging from the previously published Phase 2 clinical data, this problem seems to have been effectively resolved.


    One day before GSK announced the initiation of phase 3 clinical studies of the COVID-19 vaccine, the monoclonal antibody therapy sotrovimab jointly developed by the company and Vir Biotechnology has received FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 Adult and pediatric patients.
    (
    Biological Exploration )


    Note: The original text has been deleted


    Reference materials:


    [1]https://us.
    gsk.
    com/en-us/media/press-releases/sanofi-and-gsk-initiate-global-phase-3-clinical-efficacy-study-of-covid-19-vaccine -candidate/


    [2] [3]https://us.
    gsk.
    com/en-us/media/press-releases/gsk-and-vir-biotechnology-announce-sotrovimab-vir-7831-receives-emergency-use-authorization-from-the -us-fda/

    On May 27, local time, GlaxoSmithKline (GSK) announced that it has launched a phase 3 clinical trial of the adjuvant recombinant COVID-19 candidate vaccine developed in cooperation with Sanofi (SNF), which is expected to be in the United States, Asia, and Africa.
    More than 35,000 adult volunteers were enrolled in many regions such as Latin America.


    10 days ago, GSK just announced the Phase 2 clinical study data of this COVID-19 vaccine candidate, evaluating the immunogenicity of the two doses of the vaccine in 722 healthy volunteers 18 years and older.
    The results showed that the seroconversion rate of volunteers after the second dose of vaccination was 95%-100%, and after the completion of a single dose of vaccine, subjects who had been infected with SARS-CoV-2 also had high levels of seroconversion.
    The neutralizing antibody shows that the vaccine has a strong potential as a booster vaccine.


    The primary endpoint of this newly launched Phase 3 clinical study is the effectiveness of two doses of vaccine to prevent symptomatic COVID-19, and the secondary endpoint is the effectiveness of preventing severe COVID-19 and asymptomatic infections.
    The research will be carried out in two stages.
    First, the effectiveness of two doses of vaccine against the original D.
    614 strain will be studied, and then the effectiveness of the vaccine against the South African mutant strain B.
    1.
    351 will be explored.


    In addition, GSK and SNF will also explore the possibility of this vaccine as a booster vaccine in the next few weeks, which may create a larger market for this vaccine.


    According to GSK, the vaccine will be approved by the U.
    S.
    Food and Drug Administration (FDA) in the fourth quarter of 2021, and GSK and Sanofi will start production within a few weeks of obtaining the approval.


    It is worth noting that this vaccine of GSK and Sanofi encountered a major "crisis" in December 2020.
    Interim data from the Phase 1/2 study showed that the immune response of the vaccine did not meet expectations in the elderly.
    At that time, two pharmaceutical companies believed that this might be due to insufficient antigen concentration.
    Judging from the previously published Phase 2 clinical data, this problem seems to have been effectively resolved.


    One day before GSK announced the initiation of phase 3 clinical studies of the COVID-19 vaccine, the monoclonal antibody therapy sotrovimab jointly developed by the company and Vir Biotechnology has received FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 Adult and pediatric patients.
    (
    Biological Exploration )


    Note: The original text has been deleted


    Reference materials:


    [1]https://us.
    gsk.
    com/en-us/media/press-releases/sanofi-and-gsk-initiate-global-phase-3-clinical-efficacy-study-of-covid-19-vaccine -candidate/


    [2] [3]https://us.
    gsk.
    com/en-us/media/press-releases/gsk-and-vir-biotechnology-announce-sotrovimab-vir-7831-receives-emergency-use-authorization-from-the -us-fda/

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