March 16 (UPI) -- Initial trials of a vaccine to protect against COVID-19 started on Monday, officials with the U.S. National Institutes of Health announced.
The Phase I clinical trial evaluating the vaccine is being conducted at Kaiser Permanente Washington Health Research Institute in Seattle, with funding support from the NIH's National Institute of Allergy and Infectious Diseases.
The first patient was given the vaccine on Monday, NIH said, and the trial is expected to enroll 45 healthy adult volunteers over the next six weeks.
"Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority," NIAID Director Anthony S. Fauci said in a statement. "This Phase I study, launched in record speed, is an important first step toward achieving that goal."
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The vaccine, called mRNA-1273, was developed by NIAID scientists and their collaborators at Moderna, Inc., a biotech firm based in Cambridge, Massachusetts, with support from the Coalition for Epidemic Preparedness Innovations. The newly launched study will evaluate different doses of the experimental vaccine for safety and its ability to induce an immune response in participants.
The trial is the first of multiple steps in the clinical trial process to evaluate the vaccine's potential benefit against COVID-19, the coronavirus that has sickened more than 170,000 people in 127 countries. More than 6,000 have died from the disease since it was first identified in Wuhan, China, in late December.
In the United States, the Seattle area has been hit hardest so far by the global pandemic. Currently, no approved vaccines exist to prevent infection with COVID-19, and there are no proven antivirals to treat it.
Scientists at NIAID's Vaccine Research Center and Moderna were able to develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome and Middle East respiratory syndrome. In fact, NIAID and Moderna scientists already were already working on an investigational MERS vaccine, and these efforts gave them a head start for developing a vaccine candidate to protect against COVID-19.
Once the genetic information for the virus became available in January, the scientists selected a sequence to express the stabilized protein of the virus, which binds to human cells, in the existing mRNA platform. To date, the mRNA-1273 vaccine has already shown promise in animal models, but this is the first trial to examine it in humans.
In the study, being led Dr. Lisa A. Jackson, senior investigator at Kaiser Permanente Washington Health Research Institute, participants will receive two doses of the vaccine via intramuscular injection in the upper arm about 28 days apart. Each participant will be assigned to receive a 25 microgram, 100 microgram or 250 microgram dose at both vaccinations, with 15 people in each dose cohort.
Investigators will review safety data before vaccinating the remaining participants in the 25 and 100 microgram dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 microgram cohort.
"This work is critical to national efforts to respond to the threat of this emerging virus," Jackson said in a statement. "We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007."
