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J&J Initiates Phase III ENSEMBLE Trial for COVID-19 Vax

Will enroll up to 60,000 volunteers across three continents to study the safety and efficacy of a single vaccine dose of JNJ-78436735 versus placebo.

By: Contract Pharma

Contract Pharma Staff

Johnson & Johnson has initiated its large-scale, pivotal, multi-country Phase III trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Phase I/IIa clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. Based on these results and following discussions with the U.S. FDA, ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.

The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.

The Janssen COVID-19 vaccine candidate leverages the company’s AdVac technology platform, which was also used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. Janssen’s investigational vaccine programs.

With Janssen’s AdVac technology, the vaccine, if successful, is estimated at launch to remain stable for two years at -20 °C and at least three months at 2-8° C. This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.

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