The University of Arkansas for Medical Sciences (UAMS) is now a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, ENSEMBLE, to evaluate the safety and efficacy of 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 investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults 18 years old and older, including significant representation from those over 60.
The trial will include those both with and without other illnesses associated with an increased risk for progression to severe COVID-19. More information about the trial is available at www.ensemblestudy.com.
To enroll in UAMS’ trial of Janssen’s investigational COVID-19 vaccine candidate, call (501) 231-4852. Participants will be seen at Freeway Medical Tower at 5800 W. 10th St., in Little Rock.
Kristine Patterson, MD, is leading the clinical trial for UAMS with study coordination provided by the UAMS Translational Research Institute.
“We’re very excited to have a role in such a critical trial with a potential global impact,” said Patterson, an infectious disease specialist and associate professor in the College of Medicine Department of Internal Medicine. “Arkansans now have an opportunity to help us be part of this historic effort.”
Patterson said the study especially needs volunteers who are most likely to come into contact with the virus, including healthcare workers, first responders, school personnel, and correctional workers.
Participants will receive stipends up to $1,430 over the two-year period, depending on the type and number of visits completed.
To support the recruitment process, Janssen has developed the ENSEMBLE Study website where people interested in volunteering for the study can register. All participant registration information will be collected, handled, and stored according to local laws and regulations.
Following registration, the research centers will evaluate volunteers’ information and then potentially request physical exams before the volunteer is included in the study. The ENSEMBLE website also provides details on the trial, such as medical monitoring and a question-and-answer section.
Janssen has joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.
Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac® technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates. To date, more than 100,000 people have been vaccinated with a Janssen AdVac®-based vaccine.
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).
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.
The UAMS Translational Research Institute is supported by the National Center for Advancing Translational Sciences at the National Institutes of Health – Clinical and Translational Science Award UL1 TR003107.