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 Institutes of Health (NIH) reported March 16.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks and is currently accepting applications from Seattle residents. The first participant received the investigational vaccine March 16, the same day as the announcement.
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 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, M.D. “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. COVID-19 cases were first identified in December 2019 in Wuhan, Hubei Province, China. As of March 15, 2020, the World Health Organization (WHO) has reported 153,517 cases of COVID-19 and 5,735 deaths worldwide. More than 2,800 confirmed COVID-19 cases and 58 deaths have been reported in the United States as of March 15, according to the Centers for Disease Control and Prevention (CDC).
Currently, no approved vaccines exist to prevent infection with SARS-CoV-2.
Visit the NIH website to read more about the trial.