Phase 3 ENSEMBLE study is designed to enrol up to 60,000 adult volunteers to evaluate the safety and efficacy of Covid-19 vaccine, compared to placebo
Johnson & Johnson starts Phase 3 study of Covid-19 Vaccine. (Credit: pearson0612 from Pixabay.)
Johnson & Johnson (J&J) has commenced a large-scale, international Phase 3 clinical trial, dubbed ENSEMBLE, to evaluate its single-shot Covid-19 vaccine candidate JNJ-78436735.
Also known as Ad26.COV2.S, the company’s potential Covid-19 vaccine candidate is being developed by its pharmaceutical business arm Janssen.
Interim results from a Phase 1/2a clinical study, which showed positive safety profile and immunogenicity and talks with the US Food and Drug Administration (FDA) supported the further development of the vaccine, said the company.
The randomised, double-blind, placebo-controlled clinical trial is planned to enrol up to 60,000 volunteers, aged 18 years old and older, to evaluate the safety and efficacy of a single dose Covid-19 vaccine, compared to placebo, in participants across three continents.
Johnson & Johnson chairman and CEO Alex Gorsky said: “As Covid-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic.
“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic.
“This pivotal milestone demonstrates our focused efforts toward a Covid-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and sharing information related to our study, including details of our study protocol.”
Janssen has designed the Covid-19 vaccine candidate by leveraging its AdVac technology platform, which was previously used in the development and production of its EC-approved Ebola vaccine and build its Zika, RSV, and HIV vaccine candidates.
AdVac technology is said to help the vaccine remain stable for two years at -20°C and for a minimum of three months at 2-8° C, complementing the standard vaccine distribution channels and require no additional infrastructure to distribute it among the people in need.
Phase 3 ENSEMBLE study is conducted in collaboration with BARDA
The Phase3 study is being conducted in partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS).
J & J said that it intends to develop and evaluate its Covid-19 vaccine candidate pursuant to high ethical standards and scientific principles and will maintain transparency in sharing information related to the Phase 3 ENSEMBLE study, including the study protocol.
The company said that it is ramping up its manufacturing capacity and is on track to reach its target of supplying one billion doses of its vaccine candidate annually.
Janssen Research and Development global head Mathai Mammen said: “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. 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.”