Johnson & Johnson Starts Second Global Phase III Clinical Trial of Janssen COVID-19 Vaccine

November 19, 2020
Pharmaceutical Technology Editors

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735, Janssen’s investigational vaccine candidate for the prevention of COVID-19, has been initiated by Johnson & Johnson.

According to a Nov. 15, 2020 press release, the ENSEMBLE 2 clinical trial will complement the ENSEMBLE trial, which is still enrolling and vaccinating study participants. The ENSEMBLE 2 trial is a randomized, double-blind, placebo-controlled clinical trial that has been designed to assess whether a two-dose vaccine regimen is safe and effective in adults versus placebo.

The company aims to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom, and the United States in its ENSEMBLE 2 trial. Additionally, the ENSEMBLE 2 trial is being conducted in collaboration with the UK National Institute for Health Research.

Both Phase III clinical trials, assessing a single-dose regimen and two-dose regimen, follow positive interim study results from an ongoing Phase I/IIa clinical study, which is investigating the safety profile and immunogenicity of both a single-dose and two dose vaccination.

Source: Johnson & Johnson