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Johnson & Johnson has announced that its phase 3 COVID-19 vaccine trial is fully enrolled, with approximately 45,000 participants involved in the late-stage study.
The ENSEMBLE Phase 3 trial is being conducted in collaboration with the US Advanced Biomedical Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).
In a statement, J&J said it hopes the number of participants now enrolled in the study will be enough to generate the data necessary to determine the safety and efficacy of its COVID-19 vaccine.
This is largely due to the high levels of COVID-19 cases among the general population in places where the phase 3 trial is taking place, this includes the US, where cases have now surpassed a total of 17 million.
J&J expects interim data from the phase 3 trial to be available by the end of January 2021, although this depends on the number of COVID-19 cases observed throughout the study.
Depending on the outcome of the study, J&J said it could submit an emergency use authorization to the US Food and Drug Administration (FDA) in February, with additional health regulation applications to be conducted “in parallel. “.
Last week, J&J announced that it would decrease the size of the ENSEMBLE trial after cases increased in the US.
As cases grow, participants will be more likely to come into contact with the virus, allowing J&J to test its vaccine in a smaller population of volunteers.
J&J advanced its COVID-19 vaccine candidate to phase 3 testing in September following positive interim results from a phase 1 / 2a clinical study of the injection. The pivotal late-stage study is investigating the safety and efficacy of a single dose of vaccine versus placebo in preventing COVID-19.
Interim results from the ENSEMBLE phase 1 / 2a trial demonstrated that the injection has a promising safety and immunogenicity profile after a single dose.
J & J’s COVID-19 candidate uses the company’s AdVac technology platform, which was also used to develop and manufacture its existing Ebola vaccine, as well as to build its other investigational candidates for Zika, RSV and HIV. .
The company is also collaborating with the UK’s National Institute for Health Research (NIHR) on a phase 3 clinical trial, ENSEMBLE 2, in multiple countries that will explore a two-dose regimen of the vaccine.
This trial is currently enrolling participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom, and the United States.
