The Metro Department of Health is in talks with a Nashville medical research company about bringing a COVID-19 vaccine trial here with the goal of launching in mid-August.
There are still details to be ironed out, but Health Department Director Dr. Michael Caldwell said he hoped to have a proposal to present to the board in the next week.
Caldwell has been engaged in talks with Clinical Research Associates about bringing a vaccine trial to Nashville. Caldwell said it is up to Clinical Research Associates to choose the vaccine possibility, but added that it will be a phase three trial.
A spokesman for Clinical Research Associates said the company has been in talks with multiple pharmaceutical companies, but declined to say which ones. The trial will seek 4,000 adults, the company spokesman said.
Caldwell said pharmaceutical companies view Nashville as a desirable city for a vaccine trial because of the number of positive cases here.
“Usually you want to test a vaccine where there’s active disease,” Caldwell said. “So one of the silver linings for Nashville by having the high case load right now is we’re very attractive for research vaccine companies, who want to test the vaccine where there’s active disease because if it works you’ll be able to determine it in a shorter period of time.”
Caldwell said any additional cost incurred by participating in the vaccine trial could be paid with existing resources. He said right now there “will not seem to be any deviation from our continuing to provide all the other programs we provide to the community,” such as the COVID-19 hotline, testing centers and contact tracing efforts.
Nashville Mayor John Cooper expressed optimism about the vaccine trial coming to Nashville.
“A vaccine trial with rigorous public health safeguards, including an extensive education and informed consent process and regulatory oversight, has immense social value and would, of course, be welcome in Nashville,” Cooper said.
Pointing to Vanderbilt University also participating in a vaccine trial, he said the Health Department can play the role of promoting the trials taking place in Nashville and help identify people who can participate.
“For me, I couldn’t be more pleased to be able to find a pathway for the department of public health here to partner in giving the people of Nashville an opportunity to participate in as many of these research studies that would be able to come here,” Caldwell said. “It teaches our community about the process of research in how vaccines are developed up close.
“We’re the Volunteer State. It allows the people of the Volunteer State to choose if they want to volunteer for the most meaningful clinical research in over 100 years. Let’s be clear it is still research and not without risks. That’s what we inform people as they come to participate in the particular study depending on the vaccine.”
Caldwell said the department already partners in a tuberculosis vaccine trial and has experience in such collaborations. Caldwell, who has specialized in such clinical trial research throughout his career, said he is optimistic that a COVID-19 vaccine will be successful based in part on the wide variety of vaccines in development. Before a vaccine candidate advances to phase three trials, it already must show some effectiveness, Caldwell said.
“Once you get there you really want to make sure that the vaccine is working as you think it should and is safe,” Caldwell said, explaining that phase three trials typically seek tens of thousands of volunteers. “If you’re exposing so many more people you really want to be confident that you’re not putting people at a risk they shouldn’t be, or you’re not getting the results you expect.”
Caldwell said the fact multiple pharmaceutical companies are discussing hiring Clinical Research Associates speaks to the company’s high reputation in the medical research community. Clinical Research Associates was founded in Nashville in 1990. The company specializes in clinical trials for vaccines and medicine, communications director Will Krugman said.
Krugman said he would defer to Caldwell on the details, but partnering with a local health department helps get the word out about the trial, in addition to being able to use department facilities and some staff.
Krugman said the company has participated in studies for flu vaccines and for low testosterone disorder among other trials.
“We’re looking to recruit several patients, depending how things go, up to 4,000 participants will be needed,” Krugman said. “As long as things go as planned, mid-August would be the start date.”
Krugman said volunteers will be compensated for participating in the trial, but how much is not known yet. He said anyone over 18, generally healthy and well-managed on medications can participate. Volunteers are subject to a screening process, Krugman said
“Nashville was selected as a site because of the city’s vast experience in clinical trials, ability to rapidly enroll many patients, and because of its high infection rates,” Krugman said.
Pharmaceutical giant Moderna announced on Monday its vaccine is advancing to phase three of its clinical trials.