- Takeda's investigational Zika virus vaccine candidate (TAK-426)
progresses into Phase 1 clinical trial
- The clinical trial (ZIK-101) will evaluate safety and immunogenicity of TAK-426 in 240 subjects between the ages of 18 and 49 across the continental U.S. and U.S. territories
- Takeda's Zika program is funded with Federal funds from the
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.2 The trial will take place in the continental U.S. and U.S. territories and is being conducted under a U.S. 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
In recent years, the Zika virus has had a devastating impact, spreading
across more than 84 countries, territories or subnational areas,
including the U.S.3 In
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.1 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.2
"BARDA remains committed to making available safe and effective Zika
Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio.
Acknowledgment of Federal Funding
This project has been funded in whole or in part with Federal funds from the
About Takeda's Zika Virus Vaccine Candidate (TAK-426)
Takeda's Zika virus vaccine candidate (TAK-426) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine. The candidate is being developed as part of a broader effort to prevent the spread of the Zika virus in susceptible populations around the world.
Takeda's Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health.7 For the past 70 years, Takeda has supplied vaccines to protect the health of people in
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benefits of the transaction may not be realized; the transaction could
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The forward-looking statements contained in this press release speak only as of the date of this press release, and neither BARDA nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.
1 Takeda Newsroom: Takeda to develop Zika Vaccine with up to
2 ClinicalTrials.gov. Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants. 2017. Accessed
3 WHO Zika virus and complications: 2016 Public Health Emergency of International Concern. Accessed
4 WHO statement on the first meeting of the
6 Fifth meeting of the Emergency Committee under the
7 UNICEF Immunization Facts and Figures
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