Five North Carolina locations are joining a Phase 3 trial for a COVID-19 vaccinedeveloped by the company Johnson & Johnson, including Charlotte’s Tryon Medical Partners. Up to 60,000 total participants are expected to enroll in the study at about 250 locations worldwide.
Tryon Medical Partners, which has about 145,000 patients, said it plans to enroll up to 900 participants beginning this week. Four other North Carolina locations are involved: the Carolina Institute for Clinical Research, the Durham Veterans Affairs Medical Center, Wake Research Associates and Wake Forest Baptist Medical Center.
Participants in the trial will receive a single shot — either the experimental vaccine or the placebo — and will be monitored for two years. A Tryon spokesperson said participants do not need to live in Charlotte or be existing patients at the practice. People who participate will be paid but Tryon would not disclose how much.
Johnson & Johnson recently announcedthat it would resume recruiting people for its Janssen COVID-19 vaccine trial. The company previously paused all clinical trials of its experimental vaccine after a study participant became sick with “an unexplained illness,” according to a statement it issued Oct. 12.
According to the company, “no clear cause has been identified” for the study participant’s illness.
“Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event,” Johnson & Johnson said.
When it announced it was pausing the trial, the company said “adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
Johnson & Johnson said the independent Data Safety and Monitoring Board overseeing the clinical study recommended resuming the trial.
Tryon began participating in a separate COVID-19 vaccine trial in July. The practice enrolled about 460 people in the Phase 3 trial of a vaccine manufactured by the company Moderna, according to a Tryon spokesperson. It is one of about 90 locations across the U.S. involved in that trial.
People interested in the Johnson & Johnson COVID-19 vaccine trial at Tryon can call 704-586-9386.
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