St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center will offer a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, ENSEMBLE trial, to evaluate the safety and efficacy of the Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.
The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults 18 years old and older, including significant representation from those that are older than 60.
The trial will include those both with and without co-morbidities associated with an increased risk for progression to severe COVID-19. St. Jude and UTHSC will enroll up to 500 adults aged 18 and older.
ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
St. Jude is part of the NIAID-supported COVID-19 Prevention Network (CoVPN). The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and is designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
The St. Jude Infectious Disease Clinical Research Operations team is closely collaborating with the University of Tennessee Health Science Center’s Office of Clinical Research team and The Department of Internal Medicine Physicians to conduct this study.
More information about the trial, including participant eligibility requirements, is available at www.ensemblestudy.com.
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital is leading the way the world understands, treats and cures childhood cancer and other life-threatening diseases. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20 percent to 80 percent since the hospital opened more than 50 years ago. St. Jude freely shares the breakthroughs it makes, and every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment, travel, housing and food — because all a family should worry about is helping their child live. To learn more, visit stjude.org or follow St. Jude on social media at @stjuderesearch.