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    Home > Biochemistry News > Biotechnology News > Phase 3 clinical trial: second-generation new crown vaccine produces high levels of neutralizing antibodies

    Phase 3 clinical trial: second-generation new crown vaccine produces high levels of neutralizing antibodies

    • Last Update: 2022-05-15
    • Source: Internet
    • Author: User
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    GPB510 is a tiny protein sphere studded with 60 SARS-CoV-2 spike protein receptor-binding domains (red)
    .

    The novel coronavirus infection (COVID-19 virus) vaccine developed by the University of Washington School of Medicine has been shown to be safe and effective in late-stage clinical trials
    .
    SK Biosciences, which leads the clinical development, will apply for a license to use the vaccine domestically this month

    .

    Seattle scientists working on a new vaccine are trying to create a "second-generation" COVID-19 vaccine that is safe, effective in low doses, easy to manufacture on a large scale, and doesn't require deep freezing
    .
    These features will enable people in regions with limited medical, transport and storage resources to vaccinate globally

    .

    If GPB510 receives full regulatory approval, it will be available through COVAX, an international effort to equitably distribute COVID vaccines around the world
    .
    In addition, the Korean government has signed a purchase agreement to secure 10 million doses for domestic use

    .

    The University of Washington will license vaccine technology for free during the pandemic
    .

    A multinational Phase 3 clinical trial involving 4,037 adults over the age of 18 found that the vaccine, called GPB510, produced higher levels of protective antibodies than the Oxford/AstraZeneca vaccine Vaxzevria
    .
    In these studies, GPB510 or Vaxzevria were administered twice, 4 weeks apart

    .

    In addition, GPB510 had a higher "antibody conversion rate," the proportion of subjects with a 4-fold or greater increase in neutralizing antibody levels after vaccination
    .

    The level of T cell activation that protects the body from COVID-19 is also similar to or higher than GBP510
    .

    SK Life Sciences' Phase 1/2 clinical trial results published in November this year and announced in March this year showed that GPB510 was safe in all trial participants who received the adjuvanted vaccine and produced virus-neutralizing antibodies
    .
    On April 25, SK Bioscience issued a press release on the results of its Phase 3 clinical trial: SK Bioscience reported positive Phase 3 immunogenicity results from its clinical trial of its as03 adjuvanted COVID-19 vaccine

    .

    Unlike the earliest approved COVID-19 vaccines that used mRNA, viral vectors or inactivated virus, GPB510 is made of proteins that form tiny particles dotted with fragments of the pandemic coronavirus
    .
    The nanoparticles were designed by scientists at the University of Washington School of Medicine and advanced into clinical trials by SK Biosciences and GlaxoSmithKline with financial support from the Coalition for Epidemic Preparedness Innovations, also known as CEPI

    .
    GPB510 includes GSK's popular adjuvant AS03

    .

    "This vaccine was designed at the molecular level to deliver a key part of the coronavirus spike protein to the immune system
    .
    We know that this part is known as the affected part of the coronavirus," said Neil King, assistant professor of biochemistry at the University of Washington School of Medicine.
    The body-binding domain is the target of the most potent antibodies

    .
    "

    Two labs in the Department of Biochemistry at the University of Washington School of Medicine led the initial development of protein-based vaccines: King's lab pioneered self-assembling protein nanoparticle technology for vaccines, and Weisler's lab identified SARS-CoV-2 A key fragment of the Spike protein and integrated into nanoparticles
    .

    David Whistler, associate professor of biochemistry at Whistler University School of Medicine and HHMI researcher, has been studying the coronavirus since 2015
    .
    Using advanced electron microscopy, researchers in Wiessler's lab are the first to determine how the novel coronavirus enters human cells

    .
    They were also the first to report in the journal Cell detailed structural information about the viral spike protein, a key part of the virus' infection mechanism

    .

    In 2016, scientists at the King lab at the UW School of Medicine set out to develop a strategy to create a new type of vaccine
    .
    They engineered proteins that self-assemble into precise spherical particles, and later showed that these nanoparticles could be decorated with proteins from viruses

    .

    Working together in the early months of the COVID-19 pandemic, researchers from the two labs designed a protein nanoparticle decorated with 60 copies of the receptor-binding domain of the Spike protein
    .
    The engineered nanostructures mimic the repetitive properties of proteins on the surface of the virus, to which the immune system responds strongly

    .

    "In order to focus the antibody response where it matters most, we decided to include only a key segment of the coronavirus spike protein, called the receptor-binding domain, in the vaccine," Wiessler said.
    "

    We are pleased to see that this The strategy paid off and led to the success of the subunit vaccine
    .
    "

    In preliminary animal studies reported in the journal Cell in late 2020, the nanoparticle vaccine was found to produce high levels of virus-neutralizing antibodies at low doses
    .
    The antibodies target several different sites on the coronavirus spike protein, an ideal quality that could potentially enhance protection against future coronavirus variants

    .

    Further preclinical studies, published in the journal Nature, also showed that the vaccine produced strong protection in non-human primates and generated a strong B cell response, which may improve the vaccine's continued protection.
    time

    .

    In a recent preprint, a third dose of the vaccine was found to provide robust protection against the COVID-19 Omicron variant in animals
    .
    SK Biosciences will soon begin a third-dose trial in 750 adults

    .



    Courtesy of the University of Washington School of Medicine


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