Emory University and four other sites in the Atlanta area and Savannah are taking part in the large-scale Phase III of a national clinical trial for experimental Covid-19 vaccine mRNA-1273.
Emory administered the first dose of the investigational vaccine at the Hope Clinic of Emory Vaccine Center this week. Hundreds of adult volunteers 18 and older ultimately will be enrolled at three clinics: Hope Clinic, Emory Children’s Clinic and Grady Health System’s Ponce de Leon Center, according to a statement from Emory.
The experimental vaccine mRNA-1273 was developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, and Moderna Inc., a biotech company in Cambridge, Mass.
The first Phase III trial volunteer received the vaccine in Savannah on July 27. Thirty thousand participants will be enrolled across 89 sites nationally, including in Georgia:
- Grady Health System, Atlanta, 30303
- Children’s Healthcare of Atlanta, Atlanta, 30322
- Hope Clinic of The Emory Vaccine Center, Decatur, 30030
- Meridian Clinical Research, Savannah, 31406
- Clinical Research Atlanta, Stockbridge, 30281
Emory was part of Phase I of the mRNA-1273 clinical trial, in which researchers’ early results found the vaccine was generally well tolerated and generated an immune response among participants.
The new larger study is designed to test whether the investigational vaccine can effectively prevent Covid-19 infection or prevent severe symptoms and death associated with infection. Participants will be randomly assigned to receive either the tested vaccine or placebo, given in two injections spaced 28 days apart.
Participants will be monitored through regular clinic visits and tested over two years to see who becomes infected in the course of their daily lives.
According to ClinicalTrials.gov, Clinical Research Atlanta was not yet recruiting. But its website was taking sign-ups, in particular seeking healthcare workers, retail workers, child care and senior care workers, first responders, factory workers, mass transit workers and anyone else whose job puts them at increased risk of contracting Covid-19. Read more here.
Dr. Paul Bradley, principal investigator for Meridian Research in Savannah, told WTOC the clinic is looking for Phase III participants who are “out and about in the community,” such as healthcare workers and grocery store and other retail workers; as well as people with underlying health conditions; healthy individuals ages 18 and older with no known history of Covid-19 infection; and people aged 65 and older. Meridian Clinical Research in Savannah also took part in the trial’s Phase II, which involved 600 participants across 10 sites.
Dr. Evan Anderson is the principal investigator for the trial at Emory, as well as associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta.
Dr. Nadine Rouphael, associate professor of medicine (infectious diseases) at Emory University School of Medicine, is leading the study at the Hope Clinic, where she is interim director. Dr. Colleen Kelley, associate professor of medicine (infectious diseases) at Emory University School of Medicine, is overseeing the study at the Ponce de Leon Center.
An NIAID grant partly supported the trial at Emory.
In addition to Savannah, Omaha, Neb.-based Meridian Clinical Research is seeking Covid-19 vaccine studies participants in Baton Rouge, La.; Rockville, Md.; Grand Island, Norfolk and Omaha in Nebraska; Binghamton and Endwell in New York; and Dakota Dunes, S.D.
Eligibility criteria and a list of Phase III study locations can be found here.
Here is Emory’s list of Frequently Asked Questions about participating in the study.