Takeda Pharmaceuticals today announced that it is purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has resulted in a Phase 1 medical trial, roughly 15 several weeks after Takeda received an agreement to build up a Zika vaccine in the Department of Health insurance and Human Services Office from the Assistant Secretary for Readiness and Response Biomedical Advanced Development and research Authority (BARDA).
The randomized, placebo-controlled, double-blind trial is made to assess the safety and immunogenicity from the investigational vaccine candidate in 240 men and women subjects between 18 and 49. The Phase 1 trial will also assess several dose quantity of a vaccine candidate to aid the advancement of TAK-426 into future studies. The trial will occur within the continental U.S. and U.S. territories and is happening within U.S. Investigational New Drug (IND) application.
“We are content to achieve this important milestone, which reflects our dedication to addressing the Zika threat, along with the significant abilities of Takeda’s global organization,” stated Rajeev Venkayya, MD, President from the Global Vaccine Business Unit at Takeda. “This progress couldn’t happen to be possible with no ongoing support of, and collaboration with, BARDA.”
Takeda was selected by BARDA in September 2016 to build up a vaccine to aid the Zika response effort within the U.S. and affected regions all over the world.