USF Health and Tampa General Hospital have been selected as a site for a clinical trial testing the Novavax NVX-CoV2373 vaccine for COVID-19. They join over 100 research sites expecting to enroll more than 30,000 adult participants as part of the global search for a safe and effective vaccine to prevent COVID-19.
The USF Health/TGH research physicians are seeking more than 250 Tampa Bay area volunteers to participate in the trial; enrollment is targeted to begin in the next few weeks.
The Novavax Phase 3 clinical trial is evaluating NVX-CoV2373, an investigational vaccine that has shown promising results for increasing the body’s immune response to the COVID-19 virus. Clinical trials are used to develop new prevention methods and medical treatments. The research community and study volunteers are critical to demonstrate that a vaccine can reduce the number of outbreaks and deaths caused by COVID-19.
“USF Health is committed to advancing evidence-based medicine, and serving as a site for the Novavax Phase 3 clinical trial of NVX-CoV2373 is an opportunity to join the global effort of securing a successful vaccine,” said Charles J. Lockwood, MD, senior vice president of USF Health and dean of the Morsani College of Medicine. “By engaging in this rigorous scientific study, USF Health will contribute to the discovery of a public health solution that can quickly and safely bring an end to this terrible pandemic. This is just the latest way in which USF Health is combating the epidemic.”
Participating in a complex vaccine trial is possible because of the infrastructure TGH and USF Health have in place as a leading academic medical center, said TGH President and CEO John Couris.
“As an academic medical center, we have the experts and the infrastructure in place to help lead research that will ultimately win the fight against COVID-19,” Couris said. “We are continuing to invest in research and innovation that will push medical discovery forward to help save the lives and health of all Floridians.”
Leading the USF Health/TGH effort as principal investigator is Carina Rodriguez, MD, professor and chief of the Division of Infectious Diseases in the Department of Pediatrics in the USF Health Morsani College of Medicine. This study is one of the phase 3 vaccine trials supported by the COVID-19 Prevention Network (CoVPN), a multisite international collaboration effort funded by the National Institute of Allergy and Infectious Diseases (NIAID) that brought infectious disease experts to address the challenges imposed by the COVID-19 pandemic.
“This study is designed to evaluate the efficacy and safety of the Novavax NVX-CoV2373 vaccine and its ability to prevent COVID-19 illness in individuals 18 years and older. The trial will be inclusive of individuals at risk due to age, occupation, underlying medical conditions, and people of racial and ethnic groups who have been impacted in greater numbers by the pandemic, including African Americans, Latinx, Asian Americans, and Native Americans. We are eager to contribute to the rigorous and innovative science that is working to bring a safe and effective solution to this health threat,” Dr. Rodriguez said.
Two out of three people participating in the clinical trial will receive two intramuscular injections of the vaccine spaced at three weeks apart. The vaccine is designed to prevent COVID-19 by stimulating the immune response against the virus and helping to create neutralizing antibodies to fight COVID-19 infection. The remaining 1/3 of participants will receive injections of a placebo made of saline (sterile salt water) solution.
All participants will be randomly selected to receive the vaccine or placebo. Participants will be followed for 24 months post-vaccination to monitor their health and safety.
Having some people receive the investigational vaccine and others receive placebo is the best way to determine whether the vaccine is effective in preventing disease. To find out more about this clinical trial, please visit ClinicalTrials.gov
Enrollment information for participating in the USF Health/TGH COVID-19 clinical trial will be shared in the coming weeks.