Healthy adults who live in Nashville can volunteer to help develop vaccines for COVID-19
Clinical Research Associates, a Nashville-based clinical research firm, is enrolling nearly 4,000 volunteers to study potential vaccines for COVID-19. Trials will begin in mid-August and new volunteers can enroll until all spots have been filled. The studies, which are part of the federal Operation Warp Speed program, are phase III, randomized, double-blind, placebo-controlled and multicenter clinical trials. The vaccines are being studied for efficacy and safety.
Individuals can volunteer to participate if they are at least 18 years old, generally healthy, and well-managed on medications. If interested in participating, they can sign up by visiting covidnashville.com, emailing recruiter@CRAnashville.com, or by calling (615) 329-2222. Patients who participate will be compensated for their time, and volunteers will undergo additional medical screening for safety.
"The COVID-19 pandemic has disrupted healthcare systems, damaged families and communities, and caused significant socioeconomic impacts. We now have an opportunity to fight back and return to normalcy with help from a vaccine. Healthy Nashvillians can contribute by volunteering to participate in a clinical trial," said Linda Schipani, CEO of Clinical Research Associates.
Vaccines in phase III trials have completed Phase I and II trials. The studies are FDA regulated, IRB approved, and adhere to Good Clinical Practices.
Volunteer patients will visit CRA on Church Street to be administered an initial dose of either a potential vaccine or placebo. Once the patient receives an initial dose, they will be monitored for fifteen minutes and instructed on how to keep track of progress. Patients will be monitored for two years following the initial dosage, and will check in with study administrators at predetermined times through in-person visits, over the phone, and through a study-specific app. The study's two-year duration is to help ensure long-term safety and determine how long potential COVID-19 immunity persists.
Clinical Research Associates was chosen as a study site because of its vast experience in clinical trials, ability to rapidly enroll patients, and high infection rates in Nashville.