J&J launches second global COVID-19 vaccine trial, evaluating two-dose regimen
pharmafile | November 16, 2020 | News story | Research and Development, Sales and Marketing | COVID-19, J&J, JJ, Janssen, Vaccine
Johnson & Johnson has kicked off a second global Phase 3 trial to assess the safety and efficacy of its COVID-19 vaccine candidate, JNJ-78436735. The company already has the Phase 3 ENSEMBLE study in motion to evaluate a single-dose version of the therapy, with the aim of enrolling up to a total of 60,000 participants.
But this latest study, ENSEMBLE 2, will assess its efficacy in a two-dose formulation. Like the first, it is a multi-country, randomised, double-blind, placebo-controlled study. J&J intends to recruit up to 30,000 participants over the age of 18, “with or without stable comorbidities associated with an increased risk for severe COVID-19.”
ENSEMBLE 2 is aiming to recruit patients from the UK, the US, France, Germany, South Africa, Spain, Belgium, Colombia and the Philippines, countries chosen for their high incidence rates of COVID-19. The study is being conducted in partnership with the UK National Institute for Health Research, and will run in parallel with ENSEMBLE 1.
Both trials build on positive safety and immunogenicity interim results reported from ongoing Phase1/2a studies, which examined both single and two-dose administration in patients. This latest Phase 3 study will evaluate efficacy of the vaccine after the first and second doses to assess how a second dose may provide incremental benefit for duration of immune response.
J&J’s vaccine candidate is built off of AdVac technology which the company also successfully used to develop its EU-approved Ebola vaccine.
Matt Fellows
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