Today NIH announced the launch of a Phase 3 clinical trial to test candidate vaccine mRNA-1273, developed by NIH, NIAIDNews, and moderna_tx, to prevent COVID19. ACTIV supported the protocol development and Operation WarpSpeed provided funding.
for details. Please do not contact the NIAID media phone number or email to enroll in this trial.
Moderna is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial. The Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and NIAID are providing funding support for the trial.
NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen . SARS-CoV-2 is the virus that causes COVID-19; the spike protein on its surface facilitates entry into a cell. Moderna’s mRNA-1273 uses the mRNA delivery platform to encode for an S-2P immunogen. The investigational vaccine directs the body’s cells to express the spike protein to elicit a broad immune response.
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.
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