Tulane University School of Medicine is a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III clinical research study of a COVID-19 vaccine 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 dose of the Janssen COVID-19 vaccine candidate versus a placebo. Worldwide, the study will recruit approximately 60,000 adults 18 years old and older, including significant representation from those that are over 60.
The trial will include those with and without other conditions associated with an increased risk for progression to severe COVID-19.
Tulane will recruit up to 1,920 participants throughout the New Orleans area. There are two trial sites on campus — downtown at the Tulane Clinical Translational Unit, 1440 Canal St., and uptown in the Claiborne Avenue parking lot near Turchin Stadium. Tulane will partner with LCMC Health to house sites at New Orleans East Hospital and West Jefferson Medical Center.
The ENSEMBLE study is being initiated in collaboration with the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Other Transaction Agreement HHSO100201700018C.
More information about the trial is available at: www.ensemblestudy.com