Ochsner Health announced plans to participate as a study site for the Phase 2/3 global study sponsored by Pfizer Inc. and BioNTech SE of an investigational vaccine, BNT162b2, against SARS-CoV-2 (commonly known as COVID-19). The health system has already had multiple participants enroll.
Ochsner is one of only 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants. The site is one of two locations in Louisiana to offer the study.
Led by Ochsner Principal Investigator Dr. Julia Garcia-Diaz, Director of Clinical Infectious Diseases Research and Infectious Disease Specialist, the study will enroll a limited number of randomized participants selected from an existing pool of candidates from across Louisiana who previously expressed interest in COVID-19 research. The research team is currently in the selection process.
“Louisiana has been a COVID-19 hot spot for quite some time, and we know that the development of a vaccine is the best way to further protect our patients and community from this virus,” said Dr. Leonardo Seoane, Chief Academic Officer, Ochsner Health. “Ochsner was selected for our expertise and excellence in conducting clinical trials. This study is another tangible way we continue to play a significant role in supporting treatment, prevention and testing advances through research and clinical trials.”
Garcia-Diaz added, “Ochsner has a long history of being at the forefront of innovation, research and clinical trials. Being at the center of this unprecedented pandemic is no different. With a population who has an increased prevalence of being high-risk and who suffers from chronic disease, we are proud to be a selected site for this vaccine study and remain committed to fighting this disease and stopping the spread in our communities.”
How It Works
The Phase 2/3 study is an event driven trial that will continue enrollment on a rolling basis, enrolling up to 30,000 participants at 120 clinical investigational sites around the world.
All participants accepted into the study will be randomized to receive either the vaccine or placebo. All participants will receive two shots; 50% will receive the vaccine and 50% will receive a placebo; neither the patients nor the investigators will know what they have received.
The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response and efficacy data needed for regulatory review. The trial’s goals will be prevention of COVID-19 in those who have not been infected prior to immunization, prevention of COVID-19 regardless of whether participants have previously been infected and the prevention of severe COVID-19 in those groups.
To learn more about Ochsner’s COVID-19 response, please visit www.ochsner.org/coronavirus.