Johnson & Johnson group Janssen has initiated a second Phase III study of its experimental COVID-19 vaccine.
The two-dose regimen ENSEMBLE 2 trial will study the safety and efficacy of a two-dose regimen of the investigational vaccine for the prevention of COVID-19 in up to 30,000 participants worldwide.
Janssen will enrol participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and the US, having selected clinical trial sites in countries and areas with high incidence of COVID-19 and the ability to achieve a rapid initiation.
The Phase III ENSEMBLE study of the single-dose regimen of JNJ-78436735 continues to enrol and vaccinate study participants.
The late-stage trials follow positive interim results from the ongoing Phase I/IIa clinical study, which is studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination.
Interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated, the firm said.