Takeda Pharmaceuticals today announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial, approximately 15 months after Takeda received a contract to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).
The randomized, placebo-controlled, double-blind trial is designed to evaluate the safety and immunogenicity of the investigational vaccine candidate in 240 male and female subjects between the ages of 18 and 49. The Phase 1 trial also will assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies. The trial will take place in the continental U.S. and U.S. territories and is being conducted under a U.S. Investigational New Drug (IND) application.
“We are pleased to reach this important milestone, which reflects our commitment to addressing the Zika threat, as well as the significant capabilities of Takeda’s global organization,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda. “This progress could not have been possible without the ongoing support of, and collaboration with, BARDA.”
Takeda was selected by BARDA in September 2016 to develop a vaccine to support the Zika response effort in the U.S. and affected regions around the world.