Hinesville is at the forefront of clinical studies at the Coastal Heritage Clinical Research facility, located on the second floor of Dr. Glenn Carter’s office, 109 West Oglethorpe Highway.
Dr. Carter said he’s always had an interest in clinical research and was involved in a few studies. He offered up the second floor of his building to let Sheila Bonner, the owner and CEO of Coastal Heritage Clinical Research, open up her facility and conduct clinical research on monoclonal antibodies for COVID studies, research for a possible vaccine for respiratory syncytial virus (RSV), and clinical research for a possible vaccine to tackle the various variants of meningitis. Bonner said they are also planning a new study on asthma to start soon.
Bonner, who once worked in pharmaceutical sales, had been conducting clinical research for another company. Bonner and Dr. Carter realized they likely had enough patients that might be interested in the various studies they would be conducting. The second floor was renovated for the clinic.
The ambiance of the second-floor clinic is more like a therapeutic spa, with light-colored walls, large, comfortable sofas and chairs with plenty of fluffy pillows, and private work rooms for the patients as well as the oversight committee from the Food and Drug Administration Office and the Institutional Review Board and drug companies.
“They all monitor us, so we have offices for them to come and do their work,” Bonner said. “We are constantly monitored and kept up with to make sure everything is done right.”
The clinic opened about two years ago, at the start of the COVID pandemic, and Bonner said Coastal Heritage was the first clinic in the world to enroll a patient into the clinical studies on monoclonal antibodies.
“We are very proud of that,” she said.
According to the National Institute of Health, there are only two clinics in the state of Georgia involved in the monoclonal study, called the EVADE study, and the Hinesville clinic is one. The other is in Lawrenceville. The EVADE study is looking at how well an investigational medicine called ADG20 works and how safe it is. Researchers want to see if the drug can prevent COVID-19 or reduce the severity of the symptoms.
There are two different groups of people enrolled in the EVADE study. The first are people who have recently been in contact with someone who tested positive for COVID. The second are people who are at high risk of developing COVID due to their jobs, housing situation or lifestyle.
Some of the research participants will receive ADG20, others a placebo. Neither the study participants nor the study team will know which treatment is being provided.
The clinic was also among the first to get the needed and necessary refrigeration unit to hold COVID vaccines at the right temperature. Bonner said they also use it to store certain serums.
Bonner said each research participant is made to feel at home. She said before they get started in a study, they review all of the study materials to know exactly what they will be getting involved with. Bonner and her team — Jessica Waters, physician assistant and researcher, and Kari Pace, the clinical coordinator and paramedic — are ready to answer any questions that arise, and each person that decides to go ahead with the study must fill out the necessary consent forms.
Waters said RSV has been around for a long time, and the Centers for Disease Control and Prevention (CDC) issued a warning last January stating there might be a spike in RSV as mask mandates were lifted. She said it is primarily an illness seen in infants, but adults, particularly in the southern United States, are prone to the illness as well.
“And starting in July, we saw an exponential spike in RSV,” she said.
According to Pfizer, RSV is a leading cause of respiratory illness in adults, second to the flu, with no specific prevention and treatment options. Severe RSV can cause problems like pneumonia and can also worsen symptoms for people who have chronic obstructive pulmonary disease or congestive heart failure.
Waters said their research is being used to determine if an investigational vaccine being developed by Pfizer can help the body produce antibodies and cells to fight off RSV infection and disease in older adults.
Their upcoming study on asthma is to see if a new treatment being developed would replace the three therapies typically used in treating current asthma patients. The same is being done with their study on meningitis, where the possibility of developing one treatment to cover four variants of the illness could be used.
Read more about the clinic in the March issue of Liberty Life Magazine. For more information on their research, call (912) 596-2042, or visit their Facebook page at https:// www.facebook.com/Pelican2020/.