Johnson & Johnson (J&J) has started a phase 3 trial for the JNJ-78436735 (Ad26.COV2.S) vaccine candidate developed by Janssen Pharmaceutical Companies for the prevention of Covid-19.
The late-stage trial called ENSEMBLE to be held in multiple countries across three countries will study the safety and efficacy of a single dosage of JNJ-78436735 in comparison to placebo.
The phase 3 trial will be carried out in the US, Argentina, Brazil, South Africa, and other countries with an aim to enrol up to 60,000 volunteers.
Its participants will be 18 years and older and will include considerable numbers of those aged over 60 years. The trial will have people with and without comorbidities relating to an increased risk for progression to severe Covid-19, said the company.
Johnson & Johnson has launched the ENSEMBLE trial after securing positive interim results from a phase 1/2a study of the vaccine candidate.
The company said that the safety profile and immunogenicity shown in the phase 1/2a trial after single dosing supported further development of the vaccine candidate.
Johnson & Johnson chairman and CEO Alex Gorsky said: “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 to sharing information related to our study, including details of our study protocol.”
The JNJ-78436735 vaccine candidate is based on Janssen’s AdVac technology platform, which was used in developing and manufacturing the Johnson & Johnson’s subsidiary’s approved Ebola vaccine in the European Union.
The technology has also been used for constructing the company’s vaccine candidates for Zika, RSV, and HIV.
Last month, Janssen Pharmaceutical signed a deal worth over $1bn with the US government to manufacture and supply 100 million doses of the Ad26.COV2.S vaccine candidate.