The National Institutes of Health has announced a clinical trial evaluating a vaccine designed to protect against the coronavirus disease. The first participant received the investigational vaccine on Monday, March 16 at the Kaiser Permanente Washington Health Research Institute in Seattle.
According to the statement, the trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks.
The vaccine is called mRNA-1273 and was developed by scientists at the National Institute of Allergy and Infectious Diseases and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations (CEPI) also 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 Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
At Kaiser Permanente Washington Health Research Institute, Dr. Lisa Jackson (photo inset) is the lead researcher for the study.
“We are proud that the National Institute of Allergy and Infectious Diseases selected us to conduct this innovative trial,” said Dr. Jackson. “We’re well prepared and focused on helping to address this evolving health situation.”
Dr. Jackson is the lead researcher for the study, funded by the National Institutes of Health. She is also a physician with the Washington Permanente Medical Group for Internal Medicine.
To date, the illness caused by the infection has sickened and killed more than 100 people in the United States. News reports say many of those who have died are in their 50s, 60s, and older and did not travel abroad. mRNA-1273 is Moderna’s 10th infectious disease vaccine to begin a clinical trial.
“This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND (Investigational New Drug),” said Tal Zaks, chief medical officer at Moderna. “We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak.”
According to the Kaiser Permanente Washington Health Research Institute, there are now seven known coronaviruses that infect humans. Of the seven, four cause respiratory illness worldwide with symptoms similar to the common cold. The other three human coronaviruses evolved from animal viruses to be able to infect humans. Those newer coronaviruses include SARS, Middle East Respiratory Syndrome (MERS), and now SARS-CoV-2.
The Kaiser Permanente Washington Health Research Institute is part of the National Institute of Allergy and Infectious Diseases’ Infectious Diseases Clinical Research Consortium. The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, is funding the trial.