St. Jude Children’s Research Hospital & Univ. of TN Health & Science Center Recruit Volunteers for ENSEMBLE Trial: COVID-19 Vaccine from Janssen

St. Jude Children’s Research Hospital & Univ. of TN Health & Science Center Recruit Volunteers for ENSEMBLE Trial: COVID-19 Vaccine from Janssen TrialsiteN

St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center (UTHSC) now offer a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study known as ENSEMBLE. This large clinical trial involving up to 60,000 volunteers evaluates the safety and efficacy of the Janssen investigational COVID-19 vaccine candidate called JNJ-78436735 (Ad26.COV2.S).

A Phase 3 randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of a single dose of JNJ-78436735 versus placebo in volunteers aged 18 years old to those even older than 60. This clinical trial will include individuals with and without co-morbidities associated with an increased risk for progression to severe COVID-19. St. Jude and UTHSC will target up to 500 adults aged 18 and up.

Backed by Federal Government

The U.S. federal government via Operation Warp Speed has injected $1 billion into this prominent effort to combat COVID-19. This government collaboration has involved the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and 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 a rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.

St. Jude Children’s Research Hospital

St. Jude Children’s Research Hospital was founded in 1962 as a pediatric treatment and research facility focused on children’s catastrophic diseases, especially leukemia and other cancers. Although the hospital costs at least $2.8 million per day to run, patients are not charged for treatment. Run as a nonprofit 501(C)(3) tax-exempt organization, St. Jude treats infants, children, and teens, as well as young adults up to age 21 and for some conditions, up to 25.

With the concept founded by entertainer Danny Thomas, St. Jude Children’s Research Hospital conducts many clinical trials, many of which can be life-saving for children.

University of Tennessee Health Science Center

UTHSC is the flagship statewide, public, academic health system affiliated with the university representing one of the most prominent academic medical centers in the state. With a focus on the citizens of Tennessee and the region, UTHSC employs over 6,000 people on its faculty, staff, and not-for-profit corporation faculty practice groups. UTHSC contributes over $4 billion to the economy of Tennessee.

The organization was first launched back in 1911, representing the Memphis campus of the University of Tennessee. The research here generates nearly $100 million in annual grants from the National Institutes of Health (NIH) and private foundations. The Translational Science and Research Building and Cancer Research houses collaborative research teams for the UTHSC campus.

Call to Action: for more information for participating in the ENSEMBLE study or email [email protected].