Johnson & Johnson initiates second phase III clinical trial, ENSEMBLE 2, of JNJ-78436735 COVID-19 vaccine.

The Phase III ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide. In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. ENSEMBLE 2 is a complementary, planned, pivotal, large-scale, multi-country Phase III 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. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. While a potentially safe and effective single-dose preventive COVID-19 vaccine would have significant benefits, particularly in a pandemic setting, Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science. As such, the company is investigating multiple doses and dosing regimens to evaluate their long-term efficacy.The Phase III ENSEMBLE and ENSEMBLE 2 trials follow positive interim results from the Company’s ongoing Phase 1/IIa clinical study, which is studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination. The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated. PHASE III ENSEMBLE 2 STUDY : The Phase III 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 efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose.Janssen will aim to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States. In order to evaluate the efficacy of Janssen’s COVID-19 vaccine candidate, clinical trial sites in countries and areas with high incidence of COVID-19 and the ability to achieve a rapid initiation were selected. ENSEMBLE 2 is being conducted in collaboration with the UK National Institute for Health Research (NIHR).