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ST. LOUIS, Mo.- Washington University School of Medicine is moving into phase 3 of a clinical trial aimed at finding a safe and effective COVID-19 vaccine.  The university is a testing site for Johnson & Johnson’s phase 3 clinical research study, called the ENSEMBLE trial, to evaluate the safety and efficacy of Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.

“A safe and effective vaccine that can protect against COVID-19 infection is critical for ending the COVID-19 pandemic,” said Dr. Rachel Presti, an associate professor of medicine and medical director of Washington University’s Diseases Clinical Research Unit.   

The school of medicine will enroll up to 500 adults ages 18 and older.  Presti said adults who are at risk of getting infected or at risk of getting more severe disease could qualify for the study if their condition is stable.  She said finding a diverse group of participants is critical to ensure any potential vaccine would be effective for all populations. 

Presti said moving forward with phase 3 is possible because data from previous phases show the vaccines being tested are safe and produced a good immune response.

“We’re now at a point where we can look to see if they work in large number of people; do they work to prevent people from getting infected,” said Presti. 

She said during the next couple of months the study should be able to determine how effective a potential vaccine is compared to a placebo. 

“We’ll have safety data definitely,” said Presti.   “We might be able to say that they’re effective maybe around the beginning of the year.”

To learn more about participating in the COVID-19 vaccine trial at Washington University School of Medicine, please email or call 314-454-0058 or visit the Division of Infectious Diseases clinical trials website.