Johnson & Johnson has announced the launch of a large-scale phase 3 trial of its COVID-19 vaccine candidate – JNJ-78436735/Ad26.COV2.S – following positive interim results from a phase 1/2a clinical study of the shot.
In an interim analysis of results from the ENSEMBLE phase 1/2a trial, J&J’s vaccine demonstrated a promising safety profile and immunogenicity after a single dose.
Based on these early positive results, J&J is moving forward into a multi-country phase 3 trial, which plans to enrol up to 60,000 volunteers across three continents. The study will investigate the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.
J&J’s COVID-19 candidate uses the company’s AdVac technology platform, which was also used to develop and manufacture the J&J’s existing Ebola vaccine, as well as construct its other investigational candidates for Zika, RSV and HIV.
The pharma giant is initiating the phase 3 ENSEMBLE trial in collaboration with the US Department of Health and Human Services’ (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the US National Institute of Allergy and Infectious Diseases (NIAID).
In a separate principle agreement, J&J will also collaborate with the UK government on a phase 3 clinical trial in multiple countries to explore a two-dose regimen of its COVID-19 vaccine candidate.
“With our vaccine candidate now in our global phase 3 trial, we are one step closer to finding a solution for COVID-19. We used a highly scientific and evidence-based approach to select this vaccine candidate,” said Mathai Mammen, global head, Janssen Research & Development, J&J.
“We are extremely grateful for the tireless efforts of our researchers and for the vital contributions of those participants who have volunteered to take part in our studies. Together, we are working to help combat this pandemic,” he added.
Last week, Novavax also announced the launch of its first phase 3 COVID-19 vaccine trial in the UK. The study is being conducted in partnership with the UK government’s Vaccine Taskforce, and will evaluate the efficacy, safety and immunogenicity of Novavax’s vaccine candidate NVX-CoV2372.
The company is expecting to enrol and immunise up to 10,000 individuals aged between 18-84, with and without relevant comorbidities, over the next four to six weeks. Participants will either receive two intramuscular injections of Novavax’s vaccine and Matrix-M adjuvat, or a placebo shot.
The trial will aim for at least 25% of participants to be over the age of 65, and will also give priority to groups that have been most affected by COVID-19, including certain racial and ethnic minorities.