A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 Seattle-based healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today (March 16, 2020). The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine. The vaccine is called mRNA-1273 (a messenger RNA molecule that codes for a COVID-19 spike protein) and was developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial. “Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, MD. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.” Infection with SARS-CoV-2, the virus that causes COVID-19, can cause a mild to severe respiratory illness and include symptoms of fever, cough, and shortness of breath.
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