Johnson & Johnson vaccine trial halted by participant’s illness
Johnson & Johnson said Monday it had temporarily halted its Covid-19 vaccine trial due to an "unexplained illness" in a participant.
"We have temporarily paused further dosing in all our Covid-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant," the company said in a statement.
The US company confirmed that "the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians". The pharmacist declined to provide further details, arguing that "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".
The firm, based in New Brunswick, New Jersey, also underlined the “significant distinction between a study pause and a regulatory retention of a clinical trial”. As “a study pause, in which the study sponsor pauses recruitment or dosing, is a standard component of a clinical trial protocol.”
Also, the company considers that the “regulatory retention of a clinical trial is a requirement of a regulatory health authority, such as the Food and Drug Administration of the United States (FDA).”
On September 23, the United States National Institutes of Health (NIH) announced that the recruiting adult volunteers to a fourth Phase 3 clinical trial evaluating an investigational vaccine against Covid-19.
The trial, designed to evaluate if Janssen Covid-19 Vaccine Under Investigation (JNJ-78436725) can prevent symptomatic Covid-19 after a single dose regimen, sought to enroll up to 60 thousand volunteers in around 215 clinical research sites, both national and international.
Johnson & Johnson’s Janssen pharmaceutical companies developed the investigational vaccine and lead 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.
