The Phase III trial will assess the safety and efficacy of a single dose of the vaccine candidate. Credit: MasterTux from Pixabay.

Johnson & Johnson (J&J) has initiated the pivotal Phase III ENSEMBLE clinical trial of its Covid-19 vaccine candidate, JNJ-78436735 (Ad26.COV2.S), being developed by its subsidiary Janssen Pharmaceutical.

This large-scale, multi-country trial comes after positive interim data from a Phase I/IIa study, which showed encouraging safety profile and immunogenicity with a single vaccination.

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Based on these study data and discussions with the US Food and Drug Administration (FDA), ENSEMBLE is designed to recruit up to 60,000 participants across three continents.

The Phase III trial will compare the safety and efficacy of a single dose of the vaccine candidate to placebo in preventing Covid-19 infection.

It is set to involve subjects aged 18 years and above, with and without comorbidities, in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the US.

J&J intends to include populations that have been ‘disproportionately’ affected by the pandemic. The trial is being conducted in alliance with the US’ Biomedical Advanced Research and Development Authority (BARDA).

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The company also agreed in principle to work with the UK Government to perform a separate Phase III trial of a two-dose regimen of the Covid-19 vaccine candidate in various countries.

Janssen Research & Development global head Mathai Mammen said: “With our vaccine candidate now in our global Phase III trial, we are one step closer to finding a solution for Covid-19. We used a highly scientific and evidence-based approach to select this vaccine candidate.”

J&J is working to scale up its production capacity with an aim to provide one billion doses of a vaccine per year. It has committed to offer an affordable vaccine to the public at zero profit for emergency use during the pandemic.

If found to be safe and effective, the first batches of a Covid-19 vaccine are expected to be available for emergency use authorisation early next year.