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J&J advances COVID-19 vaccine into second phase 3 trial

ENSEMBLE study will enrol 60,000 people worldwide

Johnson & Johnson (J&J) has launched a second phase 3 trial of a single-dose regimen of its COVID-19 vaccine candidate, JNJ-78436735.

The ENSEMBLE trial is set to enrol up to 60,000 participants worldwide, while another study, ENSEMBLE 2, will evaluate a two-dose regimen of the vaccine in up to 30,000 participants.

The initiation of the parallel studies – ENSEMBLE and ENSEMBLE 2 – comes on the heels of positive interim results of J&J’s ongoing phase 1/2a clinical study of the investigational vaccine.

Interim analysis from this early-stage study, which is evaluating both a single-dose and a two-dose vaccination regimen, showed that a single dose of JNJ-78436735 induced a ‘robust’ immune response and was also generally well-tolerated among vaccinated participants.

The ENSEMBLE 2 study will enrol participants in the UK, the US, France, Germany, Spain, Belgium, South Africa, Colombia and the Philippines.

The UK-based trial will be conducted in collaboration with the National Institute for Health Research (NIHR) and is expected to recruit 6,000 participants.

The trial is being conducted in the UK as part of a deal agreed in August, which included an initial supply agreement for 30 million doses of J&J’s vaccine. As part of this deal, the UK also agreed to co-fund the phase 3 ENSEMBLE 2 trial.

The ENSEMBLE study, on the other hand, is being initiated in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

In a statement released yesterday, J&J added that while a single dose of the vaccine proved promising in the early study, it is continuing to investigate the long-term efficacy of multiple doses and dosing regimens.

“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,” said Alex Gorsky, chairman and chief executive officer, J&J.

The COVID-19 vaccine race is now entering its final stages, with both Pfizer/BioNTech and Moderna reporting the first results from late-stage studies of their respective COVID-19 vaccine candidates this month.

A number of other companies, including J&J, AstraZenenca, GlaxoSmithKline/Medicago and others, have advanced their vaccines into phase 3 testing.

AstraZeneca, which is developing its COVID-19 vaccine in conjunction with Oxford University, said earlier this month that it expects results from late-stage trials of the vaccine this year.

Article by
Lucy Parsons

17th November 2020

From: Research

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