NASHVILLE, Tenn. (WTVF) — Vanderbilt University Medical Center says it will begin recruiting 1,000 volunteers in late July for a late-stage study of an experimental COVID-19 vaccine.
Vanderbilt says the randomized, placebo-controlled Phase 3 trial will be open to people 18 and older. They will receive two shots of either the vaccine or an inactive placebo and will be followed for two years.
The goal of the study is to find out how effective the vaccine is in protecting against COVID-19 and how long the protection lasts. For more information, contact covidvaccine@vumc.org or vaccineresearch@vumc.org
According to a release, VUMC is one of several U.S. centers participating in the nationwide Phase 3 trial, which will enroll 30,000 volunteers over the next two months.
The vaccine is being developed by Moderna Inc. in collaboration with the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.
“The Moderna mRNA vaccine contains genetic material from the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The spike protein enables the virus to bind and fuse with the membrane of certain types of cells in the body, the first step in infection,” the release said in part.
Vanderbilt researchers also provided laboratory support of a Phase 1 trial of the vaccine in 45 healthy adults. “The New England Journal of Medicine” published a report Tuesday, saying the vaccine had no safety concerns and induced anti-SARS-CoV-2 immune responses in all participants.
A Phase 2 study to further examine the safety of the vaccine and its ability to create an immune response is currently underway in healthy adults.
Dr. Creech said, “We’re really looking for those who have higher risk of COVID exposure to be able to work in the study. So those working as airport screeners, professionals, those working in retail, or in the hospitality industry.”
Dr. Buddy Creech, the vaccine research director at Vanderbilt, didn’t expect it to happen this fast. “This is a very exciting time for us because if you had told me in March that we would know the genetic code in late January, and have a phase 3 trial starting in late July, I would have laughed, and now here we are.”
On Facebook some people said they didn't want to be a guinea pig. “We hold very firmly to first, do no harm,” Dr. Creech said, “What we hope is the next time someone sees the virus it’s nothing more than a common cold, and it blunts what could have been a disastrous infection.”
Volunteers will have several visits, and weekly check-ins over the phone.
“I’m ineligible for the vaccine because of being an investigator, and having had COVID myself in March of this year,”Dr. Creech said, “If things were to work as well as they have so far, we could be looking at some preliminary information by the end of the year or the first of 2021.”
