ATLANTA -- Emory University has begun enrolling adults over age 55 in the clinical trial of an investigational vaccine designed to prevent coronavirus disease 2019 (COVID-19).
Phase 1 of the vaccine trial began on March 16, 2020 and has enrolled 45 healthy volunteers ages 18 to 55 years at Kaiser Permanente Washington Health Research Institute in Seattle and Emory University in Atlanta. Both are part of the Infectious Diseases Clinical Research Consortium (IDCRC).
Investigators are now expanding Phase 1 of the trial to enroll an additional 60 participants: 30 adults ages 56 to 70 years and 30 adults ages 71 years and older. The National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) clinic at the National Institutues of Health (NIH) Clinical Center in Bethesda, Maryland has been added as a trial site. The trial is supported by NIAID, part of the NIH.
Enrolling older adult volunteers will help investigators better understand vaccination outcomes among older people, who face a higher risk of complications from COVID-19 than younger individuals. Study investigators have conducted regular safety reviews and have not identified any significant safety issues among younger volunteers. Regular safety reviews will continue as older adults are enrolled.
“Older adults are at a higher risk of suffering serious complications and needing hospitalization if they develop a COVID-19 infection,” says Evan Anderson, MD, 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. “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.”
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. The vaccine, called mRNA-1273, was developed by VRC scientists and the biotechnology company Moderna, Inc. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.
Trial data will be disseminated to public health officials and partners as soon as possible and included in scientific publications and presentations to inform the global scientific community.
For more details on the trial, please see NIAID’s March 16 press release, NIAID’s March 27 statement, and visit ClinicalTrials.gov and search identifier NCT04283461.
Investigators are no longer seeking volunteers ages 18 to 55 for this trial. Adults over the age of 55 in the Atlanta area who are interested in joining this study should contact:
- The Hope Clinic of the Emory Vaccine Center: 404-712-1371 Email: vaccine@emory.edu or
- Emory Children’s Center Vaccine Research Clinic: 404-727-4044 Email: vaccine@emory.edu
About IDCRC
The Infectious Diseases Clinical Research Consortium is a hub with the Vaccine and Treatment Evaluation Units (VTEUs) and NIAID to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. It fosters collaborative team science with NIAID, the VTEUs and other partners to best address the NIAID infectious diseases priorities. The IDCRC is made up of clinical researchers from Emory University, University of Maryland, Johns Hopkins, Vanderbilt University, Baylor University, University of Washington, University of Alabama at Birmingham, University of Cincinnati, FHI360 and NIH NIAID Division of Microbiology and Infectious Diseases.