Three phase clinical trials of Moderna vaccine
Last Update: 2020-06-19
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< br / > < br / > Moderna announced today that it has determined the design scheme of phase 3 clinical trial of its mRNA new crown vaccine based on the feedback of FDA in the United StatesAccording to the results of phase I clinical study, 100 μ g dose level was selected as the vaccination dose used in phase III clinical trial to maximize immune response and minimize adverse reactionsThe randomized, double-blind, placebo-controlled phase 3 trial, which is expected to involve about 30000 participants, will be conducted in collaboration with the National Institute of allergy and infectious diseases (NIAID), affiliated to the National Institutes of Health (NIH)< br / > the primary end point of the trial will be the prevention of symptomatic covid-19 disease; the key secondary end points include the prevention of severe covid-19 disease (defined as requiring hospitalization) and the prevention of covid-19 caused by new coronavirus infectionNovel coronavirus pneumonia is the main method of efficacy analysisModerna has completed the production of vaccine for three phases of researchThe company expects the administration of phase 3 clinical studies to begin in July< br / > at the same time, the company announced that the first phase 2 clinical trial of its new crown vaccine has completed the inclusion of a volunteer team consisting of 300 healthy adults aged 18-54, and a "pilot" queue consisting of 50 elderly people over 55< br / > regeneron today announced the launch of the first clinical trial of regn-cov2, a research-based double antibody cocktail therapy developed by the company for the prevention and treatment of covid-19The regn-cov2 clinical trial will be composed of four different research groups: inpatient covid-19 patients, non inpatient symptomatic covid-19 patients, uninfected people in high-risk exposure groups (such as medical staff) and uninfected people closely exposed to covid-19 patients (such as patients' roommates)< br / > the safety and efficacy of regn-cov2 (regn10933 + regn10987) in the treatment of inpatient and non inpatient covid-19 patients are being evaluated in the first two adaptive 1 / 2 / 3 studiesPhase 1 will focus on Virology and safety endpoints, and phase 2 will focus on Virology and clinical endpointsData from phase 1 and phase 2 studies will be used to refine the endpoints and determine the scale of phase 3 studies< br / > regn-cov2 consists of two monoclonal antibodies that bind to the key receptor binding domain (RBD) of the new coronavirus spike proteinThe RBD binding sites of the two antibodies are different, so the combination of the two antibodies can reduce the ability of the virus to evade the treatment of single antibody by generating gene mutationPreclinical studies of these two antibodies will be published in the journal Science< br / > Dr George D yancopoulos, co-founder, President and chief scientific officer of regenerator, said: "we have developed a unique anti-virus antibody cocktail therapy, which has the potential to prevent and treat infection, as well as prevent the virus from" escaping "in advance Regn-cov2 can have a significant impact on public health by slowing the spread of the virus and providing the treatment needed for those already ill Antibody cocktail therapy can also be used in the elderly and immunocompromised patients with poor vaccine response In the end, the world needs a variety of solutions from covid-19, and the innovative biomedical industry is working collectively to help as many people as possible in a variety of complementary ways " < br / > original title: covid-19 research and development trends: it is expected that the new crown vaccine of Moderna will start three clinical trials in July, and the "cocktail therapy" of regenerative meta antibody will start human trials < br / >
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