Tullahoma’s Trinity Clinical Research is currently seeking volunteers to take part in a national study on a potential COVID-19 vaccine.
According to Owner and President Roberta Adams, who has been in the clinical research field for two decades, her facility is one of four Tennessee research sites chosen by pharmaceutical giant Pfizer and German company BioNTech to conduct its Phase 3 clinical trials.
“This is involving 30,000 patients nationwide,” Adams said of the Pfizer study. “They come in and have two injections. After that, they come in on specified time periods to have bloodwork. There is a placebo group … it’s a 50/50 placebo/product trial. The bloodwork will tell whether or not the vaccine is actually working.”
Enrollment for the study began in mid-August and will conclude later in September, Adams said.
“We’re told that enrollment should end about the 25th of September,” she told The News.
As of last Saturday, Adams said her facility had enrolled its 100th patient, but she is still looking for representation from minority communities.
“Enrollment is closed at our site except for minorities,” she said. “We really, really need to have minorities represented in this study, so they’ll know whether or not the vaccine works for those communities.”
Having that minority representation in the study is important because COVID-19 affects minority communities more severely than it does white people.
“COVID-19 hits those communities four and five times more severely than it does the white population, so we need volunteers from those communities to represent and step up so we can know whether this is going to be good for them,” she said.
Adams also said she wanted to make sure those minority communities are represented in the study because they tend to be under-represented.
“In many areas, they’re vastly under-represented, and if people in this area will step up, that just really says a lot about the people in our area,” she said. “We’ve already enrolled, I think, seven. Out of 100, that’s only seven percent. We would like to double our numbers at least.”
The volunteers don’t necessarily need to be from the Tullahoma area, Adams said.
“We have people coming here from Nashville, Chattanooga, Knoxville and even Dalton, Georgia,” she told The News. “Most of them are local, but we do have a few that are coming quite a distance to participate.”
Crossing that 100-patient threshold has even garnered the facility praise from Pfizer, Adams said.
“Pfizer’s very pleased that we had such a response, so I think we’ve represented well,” she said. “That’s a pretty good sample number for this area, being a pretty rural area. There’s some places like NYU and big cities that are enrolling hundreds. To get that kind of response in this area, I was very pleased.”
According to Adams, those interested in participating in the study will come in for an initial consultation where she and her staff will go over all the particulars of the study and an informed consent form.
Study details, any reported side effects, how many visits are required and what the patient does at each visit, patient rights as a research subject, privacy rules and other regulations are given to each potential patient.
Once a volunteer accepts all the conditions and signs the consent form, Adams said, they then proceed to a medical screening.
“That’s where we go through all the inclusion and exclusion criteria to know whether or not you qualify to participate in the trial,” she said.
Exclusionary criteria include a positive COVID-19 diagnosis or taking any medications to prevent contracting COVID-19 (most notably hydroxychloroquine).
“If you meet all the criteria, then we go ahead and give you an injection,” Adams said. Patients will either be injected with the vaccine or given a placebo, though they will not know which injection they receive.
After the first injection, the patients will come back three weeks later to receive a second injection. If they received the vaccine on the first injection, they will receive the vaccine on the second injection as well, Adams said. The same goes for the placebo.
After the second injection, patients will follow up at one month, six months, 12 months and 24 months to have bloodwork done.
“That’s just blood draws to check for antibodies and to see how well the vaccine is working,” Adams said.
Participants will be required to keep a diary in order to monitor any side effects they may feel during the course of the study. The electronic diary app is downloaded onto participants’ smart phones, and patients check in every week during the study.
“You check in once a week, and they ask if you’ve had any COVID-19 symptoms,” she said. “If you have, then we follow that up. If not, then you just go onto the next week.”
There are also monetary perks to the study, Adams said.
“There are stipends involved,” she told The News. “Patients are paid $5 for every diary entry that they do. They’re paid $119 for every clinic visit that they complete, and they’re paid at the visit. We don’t make them wait.”
No penalty for participation
Should a vaccine become available soon, those in the study will not be without an opportunity to receive it.
“Eventually, the placebo group in the study will have the opportunity to take the vaccine,” she said “Pfizer’s very sensitive to that, given that this is a pandemic and the seriousness of COVID-19. When they hit their safety and efficacy end points, they are going to make the vaccine available to the placebo group if they would like to take it. They won’t be penalized, in effect, for having participated in the trial.”
Hopefully, if enough minority participants join the study, Pfizer will be able to “hit their end points, as far as knowing this is safe and effective” by the end of October.
According to Adams, only “three or four” participants report any kind of post-injection symptoms, and those symptoms were not anything unexpected.
“They’ve all been the kind of symptoms you would expect after any vaccine, not just this,” Adams said. “It’s very promising so far.”
Adams also stressed that the vaccine being tested is not the actual COVID-19 virus, and patients cannot contract COVID-19 from it.
“This is a modified RNA vaccine; it is not the actual virus; it cannot give you COVID,” she said. “It cannot make you have it or get you sick, other than the possible side effects that one would normally expect.”
Adams also addressed public suspicion surrounding the speed of vaccine production nationwide.
“A lot of people ask how could they develop a vaccine so quickly, and they’re suspicious of that, but the SARS virus is a coronavirus like the COVID-19,” she said. “There is a vaccine for SARS, so the process was already in place. They just had to isolate the RNA for the COVID-19 and then proceed from there. A lot of the background work had already been done.”
For information about how to participate, contact Adams at Trinity Clinical Research, 709 NW. Atlantic St. The phone number is 931-434-0002.