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WashU begins recruiting for phase 3 of COVID-19 vaccine trial

WashU’s School of Medicine will enroll up to 500 adults ages 18 and older in the St. Louis region

ST. LOUIS — Washington University School of Medicine in St. Louis is a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s phase 3 clinical research study.

"Phase 3 is if whether the vaccine actually work, does it prevent people from getting sick," Dr. Rachel Presti, Associate Professor of Medicine in Infectious Disease and the head of the clinical trial said.

The study, called the ENSEMBLE trial, evaluates 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 and placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single dose of the vaccine candidate versus a placebo in 60,000 adults 18 years and older, with a “significant” representation of people over 60 years old.

“A safe and effective vaccine that can protect against COVID-19 infection is critical for ending the COVID-19 pandemic,” said Dr. Presti. “In seeking volunteers, we are hoping to enroll people from diverse communities across the St. Louis region, as well as those who are at high risk of infection due to their age or the nature of their jobs, such as essential workers.”

WashU’s School of Medicine will enroll up to 500 adults ages 18 and older in the St. Louis region, according to a news release. The trial will include those with and without illnesses associated with an increased risk for severe COVID-19.

"If people have current uncontrollable medical problems, that’s going to be hard to differentiate from the vaccine, so those people would be excluded," Dr. Presti said.

She added for people whose immune systems don’t respond to vaccines, they wouldn't be a fit for this trial either.

To learn more about participating in the trial, email idcru@wustl.edu, call 314-454-0058 or visit the Division of Infectious Diseases clinical trials website. For more information about the trial, click here.

Dr. Presti says they anticipate to have the enrollment process done by mid-December.

WashU’s School of Medicine is part of the National Institute of Allergy and Infectious Diseases-supported COVID-19 Prevention Network (CoVPN). The CoVPN is composed of NIAID-supported clinical research networks with infectious disease expertise, the release stated. It is designed for rapid and thorough evaluation of vaccine candidates.