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Charleston testing site begins COVID-19 vaccine trials with patients

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Brandon Stanley (left) gets a "blind" shot from nurse Autumn Shavalier, which could be a vaccine for COVID-19 at Clinical Trials of South Carolina on Wednesday, Sept. 2, 2020, in North Charleston. The plan is to enroll 30,000 people into the the company’s third trial phase across 80 sites in the United States where patients have a 2-to-1 ratio of actually getting the vaccine. Andrew J. Whitaker/Staff

Charleston resident Dr. Brandon Stanley wasn't nervous or worried when a nurse injected him with what could be a vaccine for COVID-19. 

He had heard about a vaccine trial in the area from his niece, a nurse at the Medical University of South Carolina. He decided to follow up and be a part of the trial to join in on finding a potential solution to the pandemic. 

"You have to be proactive," he said. "You can't be on the sidelines." 

Stanley was one of the patients who took part in the first week of a vaccine trial at the Clinical Trials of South Carolina. The research trial is organized by pharmaceutical giant AstraZeneca. 

The plan is to enroll 30,000 people into the company's third trial phase across 80 sites in the United States. Clinical Trials of South Carolina is one of two locations in the Charleston area serving as a testing site. The other location is MUSC.

Both sites are expecting to enroll 1,500 residents each. The Charleston area was selected as a testing location because of its high coronavirus infection rate. At this phase of the vaccine trial, researchers are looking for patients who are likely to have more exposure to the virus. 

This includes people like first responders, grocery store staff and nurses. Stanley works in orthopedics. The goal is to test whether the vaccine will protect people from COVID-19 and if it is safe.

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Renee Jumper (left), a registered nurse, passes a dose of medicine to Autumn Shavalier to deliver to her patient at Clinical Trials of South Carolina on Wednesday, Sept. 2, 2020, in North Charleston. Andrew J. Whitaker/Staff

"We're pretty early on," said Erica DeGroff, chief operations and business officer at Pain Specialists of Charleston. "We have a long way to go." 

Clinical Trials is the research portion of the North Charleston-based Pain Specialists of Charleston. It started seeing patients for the vaccine trial on the morning of Aug. 29. It got the OK from AstraZeneca to start seeing patients the day before.

Enrollment in the trial is open for the next six to eight weeks. Patients have to be at least 18 to be involved. 

Participants are given around $100 for each of their scheduled study visits. Residents can visit to learn more about getting involved in the study. 

Researchers still have a long road ahead of them. Dr. Jeremy Ackerman is a principle investigator at Clinical Trials. He has worked previously with the company on a flu vaccine. 

That study involved between 100 and 150 patients. The 1,500-patient goal for the COVID-19 trial is a big jump, he said. 

"That's a lot of manpower," he said. "There's so much paperwork." 

The facility expects to see 40 to 45 patients a day. Each one has to be guided through a 40-page consent document to make sure they understand the process.

From there, they will go through health screenings and exams. Researchers will also be looking at patients' medical histories. Respiratory and heart conditions are some of the things that disqualify a patient from the study. 

To help with the high volume of participants, the  Army and the city of North Charleston are helping Clinical Trials build modular medical units. These will hold additional exam rooms. 

For every two patients who receive an injection of the actual vaccine, one will receive a placebo. Patients will then by monitored and connected with researchers for routine checkups and blood sample examinations. 

The vaccine isn't a live virus. It's a molecule that was created to be similar to COVID-19, DeGoff said.

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Nathelia O’Banner, a research manager with Clinical Trial holds a biometric monitor that is to be placed around a patient's arm until symptoms disappear at Clinical Trials of South Carolina on Wednesday, Sept. 2, 2020, in North Charleston. The device will track factors such as skin temperature, physical activity and respiratory and heart rates. Andrew J. Whitaker/Staff

If participants show signs of COVID-19 symptoms, a biometric monitor called a Current Health Monitoring System will be placed around their arm until symptoms disappear. That device will track factors like skin temperature and physical activity as well as respiratory and heart rates. 

Nathelia O'Banner, a research manager with Clinical Trials, said all of this work is being done with a sense of urgency. The trial is also one of the fastest that researchers at the facility have been a part of. 

Historically, the mumps vaccine is considered one of the fastest ever to be developed. It was licensed in 1967 and took four years to complete.

O'Banner has worked in drug research since 2008. She said she has only seen four drugs out of hundreds of studies get approved. 

The current COVID-19 vaccine trial will last two years. The Centers for Disease Control and Prevention is informing state health officials to be ready to distribute the vaccine to health care workers and high-priority groups as early as Nov. 1 of this year.

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a press release that positive and promising results from preclinical research and early-stage clinical trials support the vaccine's rapid development. 

"That part is exciting," O'Banner said. "It's going to be here before we even know it." 

When the vaccine is released, people in the medical field will likely take priority in terms of getting it. The current trial is potentially a way for residents to essentially skip the line, DeGoff said.

Stanley has known a few friends and family members infected with COVID-19. Those cases were mild. He, like some others, view a vaccine as a crucial step toward managing the pandemic. 

"You see the light at the end of the tunnel," he said. 

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Reach Jerrel Floyd at 843-937-5558. Follow him on Twitter @jfloyd134.

Jerrel Floyd is an Alabama raised reporter who covers Summerville and Dorchester County for The Post and Courier.

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