St. Jude Children’s Research Hospital and University of Tennessee Health Science Center begin recruiting adult participants for phase 3 COVID-19 vaccine

Researcher in mask standing in examination room.

Aditya Gaur, M.D., of St. Jude Infectious Diseases is part of a the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study to evaluate the safety and efficacy of an investigational COVID-19 vaccine candidate.

St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center will offer a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, ENSEMBLE trial, to evaluate the safety and efficacy of the 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 COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults 18 years old and older, including significant representation from those that are older than 60.

The trial will include those both with and without co-morbidities associated with an increased risk for progression to severe COVID-19. St. Jude and UTHSC will enroll up to 500 adults aged 18 and older.

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