Johnson & Johnson COVID-19 Vaccine Now on its Second Global Phase 3 Clinical Trials

The potential vaccine developed by Janssen Pharmaceutical Companies of Johnson & Johnson runs the Phase 3 ENSEMBLE single dose testing and is continuing to enroll 60,000 study participants worldwide.

On the other hand, Janssen has also initiated the two-dose regimen ENSEMBLE 2 trial. The ENSEMBLE is to test if the vaccine is safe and effective in preventing COVID-19.

“Phase 3 trial that will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate for the prevention of COVID-19 in up to 30,000 participants worldwide,” Janssen Pharmaceutical Companies said in a press release.

While the single-dose regimen is more practical in a pandemic setting, the two-dose regimen is to test the vaccine’s long-term efficacy.

“The Phase 3 ENSEMBLE 2 study (NCT04614948) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older with and without comorbidities associated with an increased risk for severe COVID-19. The study will assess the efficacy of the investigational vaccine after both the first and second doses to evaluate protection against the virus and potential incremental benefits for the duration of protection with a second dose,” the company added.

Meanwhile, Janssen is planning to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom, and the United States. (ASC)