The University of Cincinnati will host a phase 3 clinical trial to study the effectiveness of a potential COVID-19 vaccine.
Phase 3 clinical trials monitor both the efficacy of treatment and adverse reactions and typically occur over one to four years, according to the Food & Drug Administration.
The vaccine being evaluated was created by Moderna, a Cambridge, Massachusetts-based biotechnology company. According to a UC press release, previous studies of the vaccine have demonstrated in participants immune responses typical of those who have recovered from COVID-19.
UC — one of about 90 nationally participating sites selected for the National Institute of Allergy and Infectious Diseases (NIAID) funded study — expects to enroll about 500 volunteers.
“UC was chosen because we have a proven track record of high-quality research and are the number one site in the NIAID-funded, AIDS Clinical Trials Group in the U.S.,” said Carl Fichtenbaum, a co-investigator and medical director for the study. “We are proud to bring leading-edge research to Cincinnati so that we can help our community battle the COVID-19 pandemic and be part of the solution.”
Conventional vaccines work by using a small amount of a virus or an antigen to elicit an immune response from the body. Vaccines that use messenger RNA (mRNA), like Moderna’s vaccine, use mRNA to get the body’s cells to produce proteins.
Moderna’s vaccine, mRNA-1273, is one of two dozen COVID-19 vaccines being developed nationally. It works by getting the body to produce a protein similar to the kind produced by the novel coronavirus in the body, stimulating the body’s immune system to prevent infection.
Participants in the blinded, randomized study will receive either the vaccine or a placebo and are asked to keep an electronic diary of their symptoms as well as to visit UC Health clinicians over a two-year period.
“This is how healthcare and science move forward: people saying, ‘Yes, I’m willing to be involved. I see this as a community need, and this is my contribution,’ ” said Maggie Powers-Fletcher, a co-investigator on the study. “None of these studies would work without individuals in the community being willing to help.”
As Fichtenbaum said, UC and UC Health historically have been pivotal in the development of treatments for other diseases, including the oral polio vaccine and Benadryl.
The study’s first vaccines are expected to be administered in July.
If you’d like to participate in the vaccine trial, you must be at least 18 years old and have no history of infection with COVID-19. Those who have a high risk for a severe infection — like those with diabetes, heart or lung disease, or other chronic health problems — are allowed to participate in the study.
If you are interested in participating, you can call 513-245-3417 or email UCcovidresearch@uchealth.com.
This article appears in The Summer Guide.