October 08, 2020
Temple University Hospital is serving as a Phase 3 clinical trial site for Johnson & Johnson's COVID-19 vaccine candidate.
The investigational vaccine, made by Johnson & Johnson pharmaceutical segment Janssen, is being tested in a randomized, double-blind, placebo-controlled clinical trial. Known as the ENSEMBLE study, the trial will include about 60,000 adults from across the globe.
The study will look to determine the safety and efficacy of the vaccine, which is one of several candidates currently undergoing late-stage clinical trials.
Temple University Hospital will enroll up to 1,400 adults aged 18 years and older from Philadelphia and the surrounding area.
Participants must be in good or stable health, though underlying conditions are permitted if symptoms are stable and well-controlled. Only those who have not previously received a vaccine in another trial can participate.
Eligible participants will be in the study up to 2 years and 1 month. They will have up to eight visits, either at home or at the study center, with the study doctor or clinical research staff.
Several tests and assessments will be performed to monitor participants' health. These will include but are not limited to:
• Questionnaires about how participants are feeling and if they experience any COVID-19 symptoms. The questionnaire can be completed electronically via app or through a web-based portal on a home computer
• Physical examinations
• Vital signs measurements – blood pressure, heart rate, breathing rate, oxygen saturation and temperature
Qualified participants will receive study-related medical care and either the investigational vaccine or placebo at no cost. They also will be reimbursed for reasonable trial-related travel expenses to and from study visits, and may be offered the vaccine at no cost if they were given the placebo during the study.
More information about the ENSEMBLE study, including eligibility criteria, is available at the project's website.
Federal officials are hoping that they will be able to stockpile enough COVID-19 vaccines for every American by March 2021. The U.S. is manufacturing doses for all six vaccine candidates backed by Operation Warp Speed, including those from Johnson & Johnson, Pfizer, AstraZenica and Moderna.
The U.S. Food & Drug Administration this week updated safety standards for COVID-19 vaccine makers to ensure that none are introduced before they have been adequately tested.