By Kathleen Berger, Executive Producer for Science & Technology
The effort to find a COVID-19 vaccine that can prevent the disease includes St. Louisans willing to help. Residents in the St. Louis area are called on to play a role in the fight against COVID-19 by participating in clinical trials testing a variety of investigational vaccines. Residents have the opportunity to be selected as participants for different trials, currently as many as six large-scale, phase 3 clinical trials or more. That’s because researchers at the Saint Louis University Center for Vaccine Development and Washington University School of Medicine in St. Louis have been tapped to join the historic effort.
“Each one of those trials is anticipated to enroll 30,000 individuals,” said Sharon Frey, MD, clinical director for SLU’s Center for Vaccine Development and principal investigator for SLU’s vaccine trials. “So by us being allowed to participate in these trials, meaning the St. Louis community, this is a huge honor.”
Rachel Presti, MD, PHD is the director of Washington University’s Infectious Diseases Clinical Research Unit and principal investigator for the COVID-19 vaccine trials. Presti and Frey are coordinating so the two institutions can lead different vaccine trials.
“We are each committed to one of the vaccine studies, and it’s likely that there will be several more, so four or five more through the end of the year,” said Presti.
With the announcement of each trial, the next critical step is partnering with the greater St. Louis community to advance public health.
“The biggest thing that’s going to help us the most is if people get their names in that database so that we can contact as many people as possible,” said Frey. “It gives them an opportunity, everybody in the community, to be part of the solution and be able to help find an answer to ending this pandemic so that we can get our children back to school, people back to work and the global economy can get back to where it belongs.”
The trials are part of the COVID-19 Prevention Network (CoVPN) formed by the National Institute of Allergy and Infectious Diseases (NIAID), which is under the National Institutes of Health (NIH).
“Phase 3 efficacy trials are the very large trials that enroll thousands of people in order to see whether the vaccine actually works or not,” Frey said. “And if it works, how well does it work? Does it prevent disease? Does it lessen the severity of the disease? Does it keep people out of the hospital? Just how well does it work?”
“Really what we’re looking for is to enroll 500 to 1,000 people for each vaccine study at each university,” explained Presti. “So if Saint Louis University does vaccine trial A, C, and E; and then Washington University does vaccine trial B and D, we would each be trying to enroll 500 to 1,000 people in each one of those studies.”
Saint Louis University was first to recruit participants for its first COVID-19 vaccine trial, the Moderna vaccine study. SLU is part of the phase 3 clinical trial to study the effectiveness, safety and immune response generated by the mRNA-1273 vaccine, co-developed by scientists at Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
Researchers will evaluate the vaccine in adults 18 years and older who have no known history of infection with SARS-CoV-2.
Those in the study will be randomly assigned to receive the mRNA-1273 vaccine or a placebo, which will be given in two injections, 28 days apart. Participants cannot contract COVID-19 from the vaccine and will not be deliberately exposed to the SARS-CoV-2 virus.
By having a coordinated strategy to launch several phase 3 clinical trials under the COVID-19 Prevention Network, the goal is to accelerate testing, manufacturing and distribution.
According to experts, having more than one effective vaccine will likely be what it takes to successfully protect the global community.
For the clinical trials, researchers said it’s critically important to enroll participants who are likely to be exposed to COVID-19 or those at risk for severe disease from COVID-19, including participants over age 65.
To learn more about participating in the COVID-19 vaccine trials at Saint Louis University, please visit vaccine.slu.edu and complete the questionnaire or call 314-977-6333 or 1-866-410-6333.
To learn more about participating in the COVID-19 vaccine trials at Washington University School of Medicine, please email email@example.com or call 314-454-0058.