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    Home > Medical News > Medical Research Articles > Moderna Vaccine Phase I clinical data was officially published, neutralizing antibody titer exceeding the amount of recovered patients!

    Moderna Vaccine Phase I clinical data was officially published, neutralizing antibody titer exceeding the amount of recovered patients!

    • Last Update: 2020-07-29
    • Source: Internet
    • Author: User
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    Read: NEJM Published the results of the first phase of clinical analysis of mRNA-1273!---- two months ago, Moderna, a U.SmRNA technology company, said in a statement that its new coronapneumonia (COVID-19) vaccine mRNA-1273 performed well in a phase iclinical trial, with all subjects having an immune responseHowever, many vaccine experts are skeptical about the vaccine's effectiveness because no specific data have been releasedNow, some of the doubts about the vaccine may be dilutedOn July 14, local time, Moderna disclosed the results of the first phase of clinical analysis of mRNA-1273 in the journal NEJMThe study, supported by the National Institutes of Health (NIH), showed that all volunteers produced high-titer antibodies, more than most COVID-19 patients recovered, and did not have serious adverse eventsDOI: 10.1056 /NEJMoa 2022483 Subjects in this Phase 1, dose-increasing, open-label clinical trial, the researchers recruited 45 healthy volunteers between the ages of 18 and 55, 89% of whom were white and only 2% asianBetween 16 March and 14 April 2020, the subjects were first vaccinated in 3 dose groups of 28?g, 100?g and 250?g, and received a second vaccination after 28 daysWithin 7 days of vaccination, subjects were asked to record local and systemic reactions using memory aidsBecause the three subjects did not complete the second vaccination, the researchers analyzed data from only 42 subjectsThe basic characteristics of mRNA-1273 subjects Antibody reaction After the first inoculation, mRNA-1273 induced full-length SARS-CoV-2 stingy protein binding antibodies in time and dose-dependent mannerBy the 15th day, all subjects had high serum conversion ratesOn the 57th day after two vaccinations, the average titer level exceeded the average titer in the recovery period serum of patients diagnosed with COVID-19, and at a dose of 100 mg, the subjects neutralized the antibody level (measured by geometric average titer) at 231.8 on the 57th day, compared with 109.2 for patients recovering in COVID-19In addition, a dose of 100?g can cause high antibody neutralization and Reaction and Th1 skewed CD4 T cell reaction, and its reaction to the original spectrum is more advantageous than a higher doseSARS-CoV-2 Antibodies and Neutralized Adverse Reactions Data from 42 subjects recorded that more than half of the subjects experienced systemic and local adverse events such as fatigue, chills, headache, myosite and injection site pain during both vaccinationsAfter the second vaccination, 7 (54%) of the subjects in the 25-g group and all subjects in the other two dose groups reported mild, systemic adverse reactions, with 3 of the subjects reporting one or more serious events"The first phase of clinical data indicates that all doses produce a strong immune response and supports the phase III clinical first immunocompromised programme of 100 sg for the optimal dose," Tal Zaks, chief medical officer of Moderna, said in a statement"Vaccines are characterized by the ability to simulate a natural infection and trigger a response to it," said Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious DiseasesThese data look pretty good and there are no serious adverse reactionsAccording to clinicaltrials.gov, Moderna will conduct phase 3 clinical trials of 30,000 subjects on July 27, which is expected to end in three months, on October 27At the same time, Pfizer and BioNTech's mRNA-based SARS-COV-2 vaccine candidates will also enter large-scale clinical trialsRelated: the Covid-19 Vaccine-Development MultiverseFirst data for Moderna Covid-19 vaccine show it spurs an immune responseThe United States Moderna Vaccine Phase I clinical data officially published large -scale clinical launch at the end of July.
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