Researchers are expanding the COVID-19 vaccine clinical trial being carried out in part at Emory University.
Investigators are looking to add another 60 older adults as trial participants, and a third trial site has been added to Emory and the Kaiser PermanenteWashington Health Research Institute in Seattle.
Initially the trial enrolled 45 volunteers ages 18 to 55 with no chronic diseases or health conditions that affect the immune system, and who were not taking immunosuppressive medications. Seventeen of the volunteers are enrolled in the trial at Emory.
Phase 1 of the vaccine trial began on March 16. The vaccine, called mRNA-1273 and
developed by the National Institute of Allergy and Infectious Diseases (NIAID) and Moderna Inc., is the first to be tested in the United States.
Investigators are now expanding Phase of the trial to enroll a total of 60 additional participants over age 55: 30 aged 56 to 70 and 30 ages 71 and older. The NIAID Vaccine Research Center clinic at the National Institutes of Health Clinical Center in Bethesda, Md., is the third trial site.
All three sites will enroll adults ages 56 and older in the coming weeks. Participants will receive two shots of the experimental vaccine approximately one month apart and will be followed for about one year.
Older adult volunteers will help investigators better understand vaccine outcomes among older people, who face a higher risk of complications from COVID-19, according to an April 20 statement by Emory University. Study investigators have conducted regular safety reviews and have not identified any significant safety issues among younger volunteers. Safety reviews will continue regularly as older adult volunteers are enrolled.
“Older adults are at a higher risk of suffering serious complications and needing hospitalization if they develop a COVID-19 infection,” Dr. Evan Anderson, principal investigator of the vaccine study at Emory and associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta, said in the statement. “Since many older adults don’t develop as strong an immune response to vaccines, it’s critically important for us to evaluate this vaccine candidate in older adults as well.”
The goals of the Phase I study are to test whether the investigational vaccine is safe, and how much it stimulates the immune system. If the vaccine is found to be safe, future studies will examine whether it can prevent infection.
The study is sponsored by NIAID, part of the National Institutes of Health. The Emory Vaccine and Treatment Evaluation Unit (VTEU) is part of NIAID’s Infectious Diseases Clinical Research Consortium supporting this trial.
The Coalition for Epidemic Preparedness Innovations supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.