ENSEMBLE Covid-19 vaccine trial : Johnson & Johnson (J&J) has launched a multi-nation phase 3 trial called ENSEMBLE for its JNJ-78436735 Covid-19 vaccine candidate (Ad26.COV2.S), which is being developed by its subsidiary – Janssen Pharmaceutical Companies.
The US healthcare giant said that the ENSEMBLE vaccine trial has been initiated following positive interim results from its phase 1/2a clinical study. In the earlier clinical trial, the JNJ-78436735 coronavirus vaccine candidate showed that the safety profile and immunogenicity after a single dose were in favor of further development.
Johnson & Johnson said that based on the findings and after discussions with the US Food and Drug Administration (FDA), the ENSEMBLE Covid-19 vaccine trial will feature up to 60,000 volunteers in three continents.
It will be held across the US, Brazil, Chile, Argentina, Colombia, Mexico, Peru, and South Africa.
The phase 3 clinical trial will assess the safety and efficacy of a single vaccine dose of JNJ-78436735 in comparison to placebo in the prevention of Covid-19.
Commenting on the ENSEMBLE Covid-19 vaccine trial, Alex Gorsky – Chairman and CEO of Johnson & Johnson, said: “As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic.
“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic.
“This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
The JNJ-78436735 Covid-19 vaccine candidate makes use of the AdVac technology platform of Janssen Pharmaceutical. The same vaccine technology platform was used for developing and manufacturing the company’s approved Ebola vaccine in the European Union and also for constructing its Zika, HIV, and RSV, vaccine candidates.