Johnson & Johnson has announced that it has launched a multi-country Phase 3 clinical trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735. The trial was initiated based on the positive interim results of the Phase 1/2a clinical trial, which demonstrated safety and immune response with a single dose of vaccine. The study was a placebo-controlled and was designed to enroll more than 60,000 patients across three continents.
The ENSEMBLE study is a double-blind, placebo-controlled study and enrolled adult individuals. The primary endpoint is the first occurrence of molecularly confirmed, moderate to severe/critical COVID-19 after 14 days of vaccination. The study is targeted to complete by March 2023. The secondary endpoints will be analyzed following the positive results of the primary endpoint.
The study enrolled patients across Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States.
Ad26.COV2.S is a monovalent vaccine that comprises adenovirus type 26 (Ad26) vector. The vaccine was developed on AdVac technology, which Janssen has prior used to construct the Ebola vaccine, Zika, RSV, and HIV vaccine candidates.
Johnson and Johnson is developing the vaccine in collaboration with the Biomedical Advanced Research and Development Authority. The company has also collaborated with the UK government to conduct clinical trials demonstrating the efficacy of two doses of the vaccine across different countries.
Johnson and Johnson has announced that it is targeting to supply more than 1 billion doses of vaccine each year.
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