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Clinical Trials

Takeda starts phase 1 trial of Zika virus vaccine candidate

PBR Staff Writer Published 29 November 2017

Japan's Takeda Pharmaceutical has started a phase 1 clinical trial of its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate, TAK-426.

The randomized, placebo-controlled, double-blind phase 1 trial will feature 240 male and female subjects aged between 18 and 49. It will assess the safety and immunogenicity of the investigational vaccine candidate.

The study will be carried out in the continental US and US territories and is being held under a US Investigational New Drug (IND) application.

The trial, dubbed ZIK-101, will also evaluate various dose levels of the vaccine candidate to help progress TAK-426 into future studies.

The initiation of the early-stage trial of the candidate comes nearly 15 months after the Japanese pharma giant had been given a contract by the US Biomedical Advanced Research and Development Authority (BARDA) to develop a Zika vaccine.

BARDA is a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) which comes under the US Department of Health and Human Services.

Takeda 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 organization.

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

Initial data from the phase 1 trial is slated to come out in 2018. Takeda would work towards launching phase 2 studies of the Zika virus vaccine candidate should the phase 1 data support its safety and immunogenicity.

BARDA director Rick Bright said: “BARDA remains committed to making available safe and effective Zika vaccines.

“Takeda’s Phase 1 clinical study is an important step toward this goal.”

The Japanese pharma company holds an initial contract of $19.8m for the development of the Zika vaccine. This covers pre-clinical research and vaccine manufacturing costs in preparation for and through phase 1 clinical trials in the current year.

Takeda stands to receive potential funding of up to $312m if ASPR/BARDA exercises all options to advance the vaccine through phase 3 trials and filing of the Biologics License Application (BLA) in the US.


Image: An Aedes aegypti mosquito that spreads the Zika virus in humans. Photo: courtesy of James Gathany/Wikipedia.org.