As part of the National Institutes of Health COVID-19 Prevention Network, Emory University is among the institutions participating in a clinical trial for an investigational COVID-19 vaccine. The trial is sponsored by Moderna, Inc.
WHO CAN ENROLL:
For this Phase 3 trial, Emory researchers are seeking volunteers who are athigh risk of SARS-CoV-2 infection. That includes people who are unable to self-isolate, such as healthcare workers, first responders or people who work in places like grocery stores or day care centers. It also includes people who are at greater risk because of their older age or because of certain pre-existing conditions, such as diabetes or other chronic illnesses. People who are pregnant, immunocompromised or with bleeding disorders, or who have had adverse or allergic reactions to past vaccinations should not participate. However, people living with stable HIV infection can take part. Volunteers must be at least 18 years old, with no known history of SARS-CoV-2 infection.
WILL I BE INJECTED WITH SARS-CoV-2?
No. The researchers will not deliberately expose anyone to live SARS-CoV-2. The study is looking at whether the vaccine can prevent infection that occurs by people being exposed to the virus in their daily lives. This particular vaccine uses an mRNA technology, in which the body’s own cells make a single protein of the virus. The body is expected to develop an immune response to this protein, and that response could protect people who receive the vaccine against future infection with SARS-CoV-2 (the virus that causes COVID-19.) To rigorously test whether the vaccine is effective at preventing infection, half of all study volunteers will receive a saltwater injection (also called a placebo) instead of the actual vaccine product. Neither the research team nor volunteers will know whether they get the vaccine or the placebo. All volunteers are then followed to see if they later become infected with SARS-CoV-2.
WHAT DOES PARTICIPATION INVOLVE?
Volunteers accepted into the trial will receive two doses of either vaccine or placebo, 28 days apart. These are given into the arm. Participants must closely self-monitor for any reaction to the vaccine. They will be contacted weekly by researchers and must undergo regular blood tests to measure antibody response. Participation is a long-term commitment; participants will be monitored for two years.
WHAT ARE THE RISKS?
Some people who took part in earlier studies of the vaccine reported temporary side effects. These included pain, redness, and swelling at the injection site. They also included fever, headache, muscle aches, and fatigue shortly after vaccine administration. Participants who show any symptoms of COVID-19 will be tested and followed during the course of their illness.
WILL I BE PAID?
Participants will be compensated for their time and travel.
HOW DO I VOLUNTEER?
You may sign up through the registry on the COVID-19 Prevention Network website.
You may also contact one of the three Emory locations where the trial will take place:
- Emory Children’s Center (on Emory’s campus), 2015 Uppergate Dr, Atlanta, GA 30322
- Hope Clinic (in Decatur), 500 Irvin Court /Suite 200, Decatur, GA 30030
- Ponce Center (just east of Midtown), 341 Ponce De Leon Ave NE, Atlanta, GA 30308