When the COVID-19 pandemic came to the United States, Rush University students were eager to find ways to help both their fellow health care workers on the frontlines and their neighbors who were most vulnerable to the virus. Jacob Bart, a second-year student at Rush Medical College, had the unique opportunity to contribute his skills for research that could have a global impact – serving on a double-blind team working on phase three clinical trial for a potential COVID-19 vaccine.
Bart is no stranger to vaccine studies having gained extensive experience working on clinical trials before coming to Rush in Fall 2019. As an undergraduate at the University of Maryland, he worked on several research projects doing database entry, which led him to a position after graduation as a clinical research coordinator, and later a position at Meridian Clinical Research in Maryland as an associate site director managing a phase three trial for a Pfizer pneumonia vaccine.
“I tried to get as much experience as possible in different clinical areas to prepare for medical school,” he explains. “I earned my phlebotomy certificate and learned how to process blood samples in the lab. I worked on vaccine studies at various stages of testing and development for diseases such as for ebola, dengue fever, HIV and pneumonia. My role in these studies included explaining informed consent to the participants, administering the vaccine or placebo, and attending follow up visits with participants to monitor symptoms and potential side effects.”
Bart received a phone call from his previous supervisor at Meridian this past April inviting him to come back to the lab to help prepare for COVID-19 vaccine clinical trials. At this point, Bart had returned to Maryland to continue his first-year medical school studies remotely and decided to take advantage of the opportunity.
“When I returned to Meridian earlier this year, I helped set up the labs and taught staff how to draw blood and administer the vaccines,” he explained. “We had to assume that everyone in the trial had COVID-19, so training everyone on how to wear the proper PPE was extremely important.”
Meridian is running a phase three clinical trial for Moderna’s COVID-19 vaccine candidate. The vaccine trial is part of Operation Warp Speed, the federal government-initiated program to facilitate and accelerate the development, manufacturing and distribution of COVID-19 vaccines and treatments. The clinical site that Bart worked at enrolled approximately 500 patients, but the entire phase three trial includes over 30,000 participants.
“The clinical trial is a double-blind study, which means that only the pharmacist and vaccine administrator know which participants receiving the vaccine or placebo. We focused on recruiting participants who were high risk for COVID-19 – those over 65 years of age, patients with comorbidities and health care workers – as they need access to the vaccine the most,” Bart explained. “The vaccine study consisted of an initial dose, a booster 28 days later and subsequent follow up phone calls to track any COVID symptoms or potential side effects of the vaccine.”
Bart says that many of the participants he worked with in this study were very eager to find out whether not they received the vaccine. “In past vaccine studies I’ve worked on, the participants generally did not ask if they received the vaccine or placebo. In this case, the majority of participants asked if they received the vaccine and were very vocal about wanting to receive actual vaccine. It made maintaining the blind all the more important to protect the integrity of the trial. Many people were really concerned about returning to work without the protection the vaccine might offer, which was really alarming and really affirmed for me that COVID exposure is a real threat for everyone.”
“I have had the pleasure of working with Jake at our clinical research site prior to his admission to Rush, and I know that he will be a wonderful physician,” said Juliana DeVito, CCRC, internal medicine site director at Meridian Clinical Research. “The way that he communicates and cares for patients is admirable. The trial participants who got to know never forgot him because of how he brings a positive and fun light to the office while providing top notch care. I was very grateful to have him back at the site this summer to help with one of the most significant clinical trials in history.”
Bart has returned to Chicago for his second year of medical school, but the clinical trial is still in full swing as pharmaceutical companies across the globe race to successfully complete their vaccine studies. “I can’t imagine what people on the front lines are going through right now, risking their lives and livelihoods on a daily basis, as researchers work as fast as possible to find a safe and effective COVID vaccine,” Bart said. “It has been a privilege to work on something that could have such a significant impact. This is what medicine is all about – being there to do your part to make things better for people.”