Takeda completes enrollment for largest-ever study of dengue vaccine

pharmafile | April 6, 2017 | News story | Research and Development Takeda, clinical trial, dengue 

Takeda announced that it had completed the enrolment for the largest clinical trial in its history, having enrolled 20,100 children and adolescents (ages 4 through to 16). The study will test TAK-003, a tetravalent dengue vaccine candidate, and represents a major statement of intent for Takeda’s vaccine business.

The vaccine in question has already posted interim analysis of Phase 2 data into the dengue candidate. The results found that the vaccine candidate allowed the patient’s body to produce an antibody response against all four dengue virus serotypes. This response was found to also be produced across age groups, with an acceptable safety profile.

“This enrolment milestone demonstrates our commitment to a thorough evaluation of the safety and efficacy of our vaccine candidates and, subject to licensure, ensuring that they are available to all populations at risk. It follows Takeda’s recent decision to invest more than 100 million euros to build a new plant for the manufacturing of TAK-003,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda. “Beyond dengue, Takeda is pursuing a number of vaccine programs to address high-priority infectious diseases including our Zika program funded by the U.S. Government’s Biomedical Advanced Research and Development Authority (BARDA) and our polio program supported by the Bill & Melinda Gates Foundation.”

The study will take place across eight dengue-endemic countries in Latin American and Asia. Recruitment for the study began in September 2016 and took only seven months to complete. The vaccine will be administered as a two-dose regimen, after trials revealed that two doses provided a sustained immune response – with this being maintained even after two years.

The scale of the trial demonstrates the shifting focus of the company, as CEO, Christophe Weber, has identified growing Takeda’s vaccine business as one of four key areas of the business (the others are oncology, gastrointestinal issues and diseases of the central nervous system). 

Ben Hargreaves

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