Takeda Pharmaceutical Company Limited has 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 US and US territories and is being conducted under a US 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 US and affected regions around the world.

In recent years, the Zika virus has had a devastating impact, spreading across more than 84 countries, territories or subnational areas, including the US, In February 2016, the World Health Organization (WHO) declared the Zika outbreak to be a Public Health Emergency of International Concern (PHEIC) and the Centers for Disease Control and Prevention (CDC) elevated its response efforts to its highest level (Level 1). Although WHO has since declared an end to the PHEIC Zika continues to pose a significant threat to public health, especially for pregnant women, and a vaccine is still needed.

Given the public health threat posed by Zika, Takeda mobilized a multifunctional team immediately following signature of the contract with BARDA and has prioritized all aspects of the development program, enabling the phase 1 trial to start within 15 months of funding. Initial data from ZIK-101 are expected in 2018, and, if available phase 1 data support it, Takeda will work toward initiating Phase 2 studies as soon as possible.

“BARDA remains committed to making available safe and effective Zika vaccines,” said Rick Bright, Ph.D., BARDA director. “Takeda’s phase 1 clinical study is an important step toward this goal.”

Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio.