Hattiesburg Clinic is one of only 89 sites chosen to participate in a clinical research trial that will investigate a potential vaccine for COVID-19 through its MediSync Clinical Research program.
The study, which is sponsored by biotechnology company Moderna, is designed to test how safe and effective the study vaccine is at preventing illness after someone is exposed to the SARS-CoV-2 virus, and will recruit Hattiesburg Clinic patients from across south Mississippi to enroll in the trial.
“We’re quite honored, and we’re quite proud that we can bring this level of innovation to our community,” said Dr. Rambod Rouhbakhsh, who serves as faculty physician and program director at the Forrest General Hospital Family Medicine Residency Program. “This represents just a piece of what the clinic has done since the pandemic began.
“It’s important to know that after we diagnosed the very first case in the state on a Thursday, the discussion was had on Saturday to devise a brand-new clinic to help take care of patients. Six days later, the Cough & Fever Clinic became what is now the regional referral center of COVID-suspected cases. Without that piece of innovation, the rest of the clinic could not function as it normally does.”
Rouhbakhsh said this trial is the clinic’s attempt at the prevention side of the COVID-19 pandemic.
“We’re very pleased to be involved in the latest Phase III trial, which means our community will have access to this as early as any other community in the world,” he said. “This is the Moderna vaccine that you have heard so much about in the news.
“It’s a novel RNA messenger vaccine that’s designed to not only be efficacious with lower side effects, but to be able to be ramped up very, very quickly so that we can get many billions of those out around the world if this winds up being a efficacious treatment.”
Enrollment for the trial will begin in early August, and officials are relying on the physicians’ internal network to understand the inclusion and exclusion criteria for patients. Individuals interested in the enrollment process can visit https://bit.ly/30ese0wor call (601) 544-1866.
“This study is focused on the critically-needed vaccine recipients, so we’re preferentially looking at those that are high risk – older patients and those with (underlying) illnesses,” Rouhbakhsh said.
Because the trial will be so large and will rapidly enroll patients, officials are looking for other doctors who would be willing to volunteer their time to participate in the study.
“I’ve been fortunate enough that I work in an academic setting here at the residency program, and many of my faculty colleagues have already volunteered some of their own off time to participate as investigators,” Rouhbakhsh said.
Because the study is a randomized, placebo control trial, the participants and investigators will not know which group is getting the placebo and which group is getting the investigational medication. Doctors will follow patients for the duration of the trial to monitor their symptoms and response to the investigational drug.
“That information is processed centrally at Moderna to purposefully keep the investigators blinded, so we don’t treat the individual study participants any differently,” Rouhbakhsh said. “Once Moderna gets data … if that data is so compelling, and it shows that it’s so effective, we could potentially end this trial early. It would be unethical to continue with it and deny the group of placebo patients the access to this investigational trial.”
Rouhbakhsh said the trial probably won’t end until the early part of 2021 at best.
“You have to bear in mind that if we give the vaccine to one group and the placebo to the other, we then send both groups out into the world and see what becomes of them,” Rouhbakhsh said. “The placebo group will have to get the illness for us to know that there’s a difference between that and the investigational arm, and that takes time.
“Unfortunately, in America, we have a lot of cases, and so the likelihood of getting this illness is quite high if you don’t have the vaccine. So we may get that data sooner rather than later, but it will take some time.”