Japan-based Takeda Pharmaceutical has started a Phase I clinical trial (ZIK-101) of its vaccine candidate, TAK-426, for the treatment of the Zika virus infection.

The move follows a contract received by the firm in September last year from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine for the infection.

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TAK-426 is a purified, inactivated, alum-adjuvanted investigational vaccine candidate being developed to aid in the prevention of the spread of the virus.

The randomised, double-blind, placebo-controlled Phase I trial will investigate the safety and immunogenicity of TAK-426 in 240 male and female participants aged 18-49 years.

Set to be conducted in the US, the ZIK-101 trial will evaluate various dose levels of the candidate to support its progression into future clinical trials.

“The firm expects that the initial results from the Phase I ZIK-101 trial will be available next year.”

Takeda Pharmaceutical Global Vaccine business unit president Rajeev Venkayya said: “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 organisation.

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“This progress could not have been possible without the ongoing support of, and collaboration with, BARDA.”

The firm expects that the initial results from the Phase I ZIK-101 trial will be available next year and will potentially support TAK-426’s evaluation in Phase II trials.

In addition to the Zika virus, Takeda is working towards the development of vaccines for high-priority infectious diseases such as dengue, norovirus, and polio.