The US Food and Drug Administration has granted fast track designation to Japan-based Takeda Pharmaceutical for its Zika virus vaccine candidate, TAK-426, it was reported yesterday.
The product is a purified, inactivated, alum-adjuvanted and whole Zika virus vaccine candidate. Presently, the company's Zika vaccine candidate is being evaluated in a phase 1 trial named ZIK-101 as part of the US investigational new drug application.
ZIK-101 is a randomised, placebo-controlled and double-blind trial designed to evaluate the safety and immunogenicity of the firm's investigational Zika vaccine candidate in 240 male and female subjects between the ages of 18 and 49. The study will evaluate various dose levels of the vaccine candidate to support the expansion of Zika vaccine candidate into further studies.
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