- The Fast Track designation highlights the
significance of Zika and the need for a safe and effective vaccine to protect
- A Phase 1 clinical trial (ZIK-101) was recently initiated to evaluate Takeda's Zika vaccine candidate (TAK-426) in the continental U.S. and U.S. territories
- Takeda's Zika program is supported by federal funds from
The FDA's Fast Track designation is a process
designed to facilitate the development and expedite the review of drugs and
vaccines for serious conditions and that fill an unmet medical need. The Fast
Track process allows more frequent interactions with the
Zika can cause congenital Zika syndrome (CZS), including microcephaly and other congenital brain abnormalities, in infants born to mothers infected during pregnancy.1 The virus has also been associated with neurological complications, including Guillain-Barre Syndrome (GBS), in the general population. The Zika virus has spread in recent years to more than 84 countries, territories or subnational areas, including the U.S.2 There is currently no vaccine or medicine for Zika.3
recognize the public health threat posed by the Zika virus," said Laurence De
Moerlooze, PhD, Global Zika Program Lead. "As soon as Takeda received funding
from BARDA, we mobilized a team and prioritized development of this vaccine
candidate, initiating a Phase 1 trial within 15 months of contract signature.
With Fast Track designation, the ongoing support of BARDA, and the abilities of
our organization, we are confident that we will continue to make expedient
progress. We look forward to continuing to work closely with the
Takeda's Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) under a U.S. Investigational New Drug (IND) application. If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.
Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio. Takeda's dengue vaccine candidate, TAK-003, was also granted Fast Track designation and is currently being evaluated in a pivotal Phase 3 efficacy study, with initial data expected this year.
Acknowledgment of Federal Funding
This project has been funded in whole or in part with Federal funds from the
Zika is caused by a virus transmitted primarily by Aedes aegypti mosquitoes.1 Symptoms of Zika may include mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headache.1 According to the
ZIK-101 is a randomized, placebo-controlled, double-blind trial designed to evaluate the safety and immunogenicity of Takeda's investigational Zika vaccine candidate (TAK-426) in 240 male and female subjects between the ages of 18 and 49.7 The Phase 1 trial is designed to assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies.7 The trial is taking place in the continental U.S. and U.S. territories and being conducted under a U.S. Investigational New Drug (IND) application.7
(Clinicaltrials.gov identifier: NCT03343626)
Takeda's Commitment to
Vaccines prevent more than two million deaths each year and have transformed global public health.8 For the past 70 years, Takeda has supplied vaccines to protect the health of people in
For more information, visit https://www.takeda.com/newsroom/.
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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.
7. ClinicalTrials.gov. Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants. Retrieved
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