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The multinational Johnson & Johnson announced on Monday that it stopped trials of an investigational vaccine against COVID-19 due to an “unexplained illness” in a participant.
“We have temporarily halted the administration of new doses in all of our clinical trials of the COVID-19 candidate vaccine, including the phase 3 ENSEMBLE trial, due to unexplained illness in a study participant,” the firm said in a statement.
The US company confirmed that “the participant’s illness is being reviewed and evaluated by the Data Security Monitoring Board (DSMB) independent of ENSEMBLE”, as well as by his doctors.
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The drugmaker declined to provide further details, arguing that they must “respect the privacy of this participant.”
“We are learning more about the disease from this participant and it is important to have all the data before sharing additional information,” the statement added.
The New Brunswick, NJ-based firm underscored the “significant distinction between a study break and a regulatory hold on a clinical trial.”
“A study hiatus, in which the study sponsor pauses recruitment or dosing, is a standard component of a clinical trial protocol,” explained Johnson & Johnson.
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Meanwhile, he added, that the “regulatory retention of a clinical trial is a requirement of a regulatory health authority, such as the US Food and Drug Administration (FDA).”
On September 23, the United States National Institutes of Health (NIH) announced that it had begun recruiting adult volunteers for a fourth Phase 3 clinical trial evaluating an investigational vaccine against COVID-19.
The trial, designed to evaluate whether the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single-dose regimen, sought to enroll up to 60,000 volunteers at around 215 clinical research sites, both national and international.
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Johnson & Johnson’s Janssen pharmaceutical companies developed the investigational vaccine and are leading the clinical trial as a regulatory sponsor.
Janssen’s candidate vaccine is a recombinant vector that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.
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