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    Home > Active Ingredient News > Infection > GSK adjuvant recombinant new crown vaccine enters Phase 3 clinical trials, and the study was postponed due to insufficient immune response

    GSK adjuvant recombinant new crown vaccine enters Phase 3 clinical trials, and the study was postponed due to insufficient immune response

    • Last Update: 2021-06-05
    • 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.

    Image source FierceBiotech 10 days ago, GSK just announced the Phase 2 clinical study data of this COVID-19 vaccine candidate, which evaluated the immunogenicity of 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 vaccination, 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 effect of two doses of vaccine against the original D.
    614 strain will be studied, and then the protective effect of the vaccine against the South African mutant strain B.
    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.

    Thomas Triomphe, Global Executive Vice President and Global Head of Sanofi Pasteur, said: “I am very pleased to see the start of this pivotal Phase 3 clinical study of the COVID-19 vaccine.
    We firmly believe that Sanofi’s unique technology platform will provide A new candidate vaccine.

    "According to GSK, it is expected that this vaccine will be approved by the U.
    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 GSK and Sanofi’s vaccine 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

    , this problem seems to have been effectively resolved from the previously announced Phase 2 clinical data.

    One day before GSK announced the launch of the Phase 3 clinical study of the COVID-19 vaccine, the company and Vir Biotechnology jointly developed a single The clonal antibody therapy sotrovimab has received FDA Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 adults and children.

    As the COVID-19 vaccine enters a critical research phase, it is believed that GSK will be in the fight against the "epidemic" Play a bigger role.

    End reference materials: [1]https://us.
    com/en-us/media/press-releases/sanofi-and-gsk-initiate-global-phase-3-clinical-efficacy-study-of-covid -19-vaccine-candidate/[2]https:// q4-approval[3]https://us.
    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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