Ochsner Hospital for Children To Enroll Adolescents in Pfizer Phase 2/3 Investigational Vaccine Study Against COVID-19
The System Is One of 24 National Sites and the Only Children’s Hospital in LA to Participate in Study
Ochsner Hospital for Children announced its participation as a study site for the expanded Phase 2/3 global study sponsored by Pfizer Inc. and BioNTech SE of an investigational vaccine, BNT162b2, against COVID-19. Originally introduced in late July for adult volunteers ages 18-85, the Pfizer Phase 2/3trial – with U.S. Food and Drug Administration (FDA) approval – is now seeking children and adolescent volunteers ages 12-17.
Led by Ochsner Principal Investigator Dr. Julia Garcia-Diaz, Director of Clinical Infectious Diseases Research and Infectious Disease Specialist and Dr. William Lennarz, System Chair of Pediatrics, Ochsner is one of only 24 clinical investigational sites around the country and the only location from Lafayette, LA to Florida to offer the study. The goal is to enroll up to 100 participants and the Ochsner research team is currently in the selection process.
“The adolescent cases of COVID-19 we’ve treated at Ochsner Hospital for Children have ranged from mild to very severe illness, including patients with pediatric multisystem inflammatory syndrome – a serious inflammatory response which affects multiple organs, including the heart. As a destination for pediatric care, we are committed to playing a key role in identifying a safe and effective vaccine for the benefit of all – including adolescents,” said Dr. Lennarz.
Garcia-Diaz added, “By working hand-in-hand with our colleagues across the globe, Ochsner continues to play a key role in the search for a solution to build immunity against COVID-19. As different age brackets have had varying degrees of symptoms to COVID-19, we recognize the vital importance of participating in a study focused on addressing the unique needs of the children and adolescent population.”
How It Works
Similar to the adult study, this Phase 2/3 study is an event driven trial that will continue enrollment on a rolling basis, enrolling up to 100 participants across the 24 national clinical investigational sites. The Phase 2/3 trial is designed in this way to obtain safety, immune response and efficacy data needed for regulatory review.
All participants accepted into the study will be randomized to receive either the vaccine or placebo, and will receive two shots with the second dose, or booster, given three weeks after the initial dose. Fifty percent of the participants will receive the vaccine and 50% will receive a placebo; neither the patients nor the investigators will know what they have received.
Subjects are enrolled in the trial for two years which includes periodic blood draws and nasal swabs about half a dozen quick check-ups after the initial enrollment and vaccine dose. Participants must be in the age range of 12-17 years-old at the time of enrollment, no pre-existing conditions and approved guardian consent.
Ochsner remains committed in playing a key role in the search for a solution to build immunity against COVID-19. With more than 30 COVID-19 clinical trials, the health system has participated in the Pfizer vaccine trial for adults and is currently recruiting for the Janssen ENSEMBLE vaccine trial.
If you or someone you know are interested in participating in COVID-19 research opportunities at Ochsner, please email COVIDVaccine@ochsner.org.
To learn more about Ochsner’s COVID-19 response, please visit www.ochsner.org/coronavirus.
About Ochsner Health
Ochsner Health is a system that delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate. Ochsner Health is a not-for-profit committed to giving back to the communities it serves through preventative screenings, health and wellness resources and partnerships with innovative organizations that share our vision. Ochsner Health healed more than 876,000 people from across the globe in 2019, providing the latest medical breakthroughs and therapies, including digital medicine for chronic conditions and telehealth specialty services. Ochsner Health is a national leader, named the top hospital in Louisiana and a top children’s hospital by U.S. News & World Report. As Louisiana’s leading healthcare educator, Ochsner Health and its partners educate thousands of healthcare professionals annually. Ochsner Health is innovating healthcare by investing in new technologies and research to make world-class care more accessible, affordable, convenient and effective. Ochsner's team of more than 26,000 employees and 4,500 providers are working to reinvent the future of health and wellness in the region. To learn more about Ochsner Health, please visit www.ochsner.org. To transform your health, please visit www.ochsner.org/healthyyou.