At a glance, this doesn’t look like the kind of place that could defeat coronavirus.
The building is beige and bland. A sign for the company inside, Clinical Research Associates, is small and easy to overlook. It is wedged between an auto shop and strip club where the dancers perform in protective masks.
In this humble building on Church Street, doctors and nurses have tested some of the most recognizable drugs on the market. Clinical trials were held here for Ambien, Zantac, Viagra and vaccines for flu and Ebola. And now, as the nation faces the deadliest pandemic in a lifetime, studies done within these walls may help find a silver bullet to save the day.
Or they could be a dead end. To find out, it will take need time, data and volunteers — lots of volunteers.
“This is a way to help your friends and neighbors and your country to get back to the closest semblance of normal we can, as fast as we can,” said Dr. Stephan Sharp, the medical director for Clinical Research Associates, which is recruiting volunteers for two coronavirus vaccine clinical trials in Nashville. “This is a way to do your part.”
The search for a coronavirus vaccine is a footrace that will have clear winners and no losers. Pharmaceutical companies are developing drugs to stop a pandemic that has infected more than 23 million people and killed over 800,000. Masks and social distancing can slow the virus, but the world is unlikely to find any true relief until billions of people are immune, ideally through mass vaccination instead of exposure.
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President Donald Trump has said a coronavirus vaccine could be ready by Election Day, but public health experts insist this is virtually impossible and far more likely a vaccine is ready in 2021. Ideally, multiple vaccines will be proven safe and effective, accelerating the speed with which drugs can be manufactured and dispensed.
Dr. James Hildreth, an infectious disease expert who leads Meharry Medical College, said Thursday he expects as many as three vaccines to be in circulation by next summer. Hildreth said recent studies show people who survive the virus maintain “memory cells” trained to produce antibodies and combat a second infection.
“This observation provides strong support for the idea that when you get COVID-19 your body generates memory cells and when you see the virus again, it is very likely that the response will limit disease and keep you from getting a recurrent infection,” Hildreth said. “So, if the right vaccine candidate is chosen, we can be pretty confident that the vaccine will probably work.”
Three coronavirus vaccines in trials in Nashville
At least three potential vaccines are undergoing clinical trials in Nashville.
Clinical Research Associates, which operates out of the beige building in Midtown, is testing vaccines by Pfizer and AstraZeneca. Vanderbilt University Medical Center, the largest and most sophisticated hospital in Nashville, is simultaneously testing a vaccine developed by Moderna in conjunction with the National Institutes of Health.
Both Clinical Research Associates and Vanderbilt said they are also in discussions with other drug companies about starting additional trials in the near future. Nashville is a desirable location for trials because it is a viral hot spot, which increases the odds of producing compelling results faster.
One of the first participants in the Vanderbilt trial was Tennessee Sen. Richard Briggs, R-Knoxville, a cardiovascular surgeon who said he was inspired to volunteer after becoming exasperated with the politicization of coronavirus.
The process was easy, Briggs said. During an appointment at Vanderbilt on Aug. 13, he got a physical exam and a coronavirus test, then signed some legal waivers. He received an injection into his arm — either a vaccine or a placebo — and set a date to receive a second dose in September. Briggs was also asked to download an app to document any side effects. So far, he has reported none.
“I wanted to be a source of facts,” Briggs said, adding later, “Am I a guinea pig? Yes. Could there be some harm from this? Maybe. But it’s really a part of what I consider public service.”
‘Roll up your sleeve’ to combat coronavirus
Volunteers like Briggs are still needed for the three trials underway in Nashville. Participating a trial like this one, doctors say, is likely the best way an average American can contribute to the campaign effort to rescue the world from the virus.
“During this pandemic, we are all in some way trying to roll up our sleeves and help get rid of it. And a remarkable way to do that is to literally roll up your sleeve and accept a vaccination,” said Dr. Buddy Creech, director of the Vanderbilt Vaccine Research Program.
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The vaccines being trialed in Nashville have already progressed through animal testing and small-scale human trials. The new trials, which involve thousands of participants in Nashville and other cities across the nation, are a final step before vaccines are submitted to the U.S. Food and Drug Administration for review.
All three trials are testing multi-dose injections that create immunity by exposing the body to an inert fragment of the virus. Participants, some of whom will unknowingly receive a placebo, will be monitored for two years with doctors’ visits, blood tests and phone calls to measure both effectiveness and any potential side effects.
There are many questions to answer. Will the vaccines produce an antibody response? Most likely. Will the antibodies actually protect you from coronavirus? Uncertain. And if the antibodies do protect you, how long will that protection last? Another mystery to solve.
If one of these vaccines is shown to produce strong, long-lasting defense to coronavirus, it still might not be safe for everyone. Clinical trials also identify people who have bad reactions to drugs for unexpected reasons.
“You need to know where the warts are,” said Sharp, who leads the trials at Clinical Research Associates. “You always need to know who should not get a drug or a vaccine, too. That’s just as important as getting it out there for the masses.”
Vanderbilt specifically looking for Black, Latino participants
The Nashville clinical trials will span two years, but should produce results as they proceed. If a trial shows strong evidence in a few months that a vaccine can prevent or weaken infections, the drug may be rushed to the FDA for provisional approval.
Clinical Research Associations, looking for 4,000 volunteers across two trials, has signed up about 600 participants after three weeks of recruiting, which the company described as much faster than prior trials for flu or Ebola vaccines.
Vanderbilt said it is not permitted to disclose how many participants have already been recruited for the Moderna trial, but confirmed it still needs more.
Vanderbilt is particularly looking for residents who face extra risk: people ages 18 to 65 who are more vulnerable to coronavirus because of a medical condition, and residents over the age of 65 who are likely to be exposed to the virus, possibly because they are essential workers or live with family members who are essential workers.
Vanderbilt is also specifically looking for Black and Latino participants to ensure the trial is reflective of the local community and includes minorities who have been most impacted by coronavirus, Creech said.
“We really want to do a good job balancing that in this study,” he said. “So when the vaccines are available, those communities have the confidence … it has been evaluated in a lot of different types of people, including those who have been hardest hit.”
Brett Kelman is the health care reporter for The Tennessean. He can be reached at 615-259-8287 or at firstname.lastname@example.org. Follow him on Twitter at @brettkelman.
Coronavirus vaccine: How to help
At least three coronavirus vaccine clinical trials are underway in Nashville, and they all need volunteers. If you are interested in participating, this is what you need to know.
- Clinical Research Associates, at 1500 Church Street, is hosting clinical trials for vaccines developed by Pfizer and AstraZeneca. Both vaccines are multi-dose injections. The company is looking for 4,000 participants who are 18 or older and generally healthy. For more info, call 615 329 2222 or visit clinicalresearchassociates.com.
- Vanderbilt University Medical Center is performing a clinical trial on a two-dose vaccine developed by Moderna. Vanderbilt is looking for about 1,000 participants, including younger adults with medical conditions that make them more vulnerable to the coronavirus and older adults who are likely to be exposed to the virus. Vanderbilt is also especially interested in recruiting participants who are Black and Latino. For more information, contact email@example.com or firstname.lastname@example.org.