The company is planning to move forward after receiving a recommendation from the DSMB to start up the trial again.
Johnson & Johnson (J&J) announced it is preparing to resume their COVID-19 vaccine trial. While they did not set a timetable, this signals a return to their study after a pause to their trial back in mid-October.
They paused their trial a couple of weeks ago due to an unexplained illness in a vaccine participant. “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the phase 3 ENSEMBLE trial,” the company said in a statement at that time.
The company did not offer any more information about the illness when it happened. “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
And in the latest statement the company still did not disclose the illness. “After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” the company said in a statement. “There are many possible factors that could have caused the event. 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.”
The independent Data Safety and Monitoring Board (DSMB) overseeing J&J’s Trial has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration, preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway. Discussions with other regulators around the world to resume the clinical trial program are progressing.
J &J’s ENSEMBLE trial is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single dose of a vaccine versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those who are over age 60.