TAK-426 (PIZV) Zika Vaccine Description
Takeda's TAK-426 (PIZV) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
The vaccine being tested in a phase 1 study is called PIZV or TAK-426 adjuvanted with aluminum hydroxide. The Zika virus vaccine is being tested to provide safety and immunogenicity data to enable the vaccine to be further developed clinically.
The study will enroll approximately 240 participants.
The Zika virus was first reported in continental South America in Brazil in May 2015.
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide.
TAK-426 (PIZV) Zika Vaccine Indication
TAK-426 is a vaccine candidate to prevent the Zika virus.
TAK-426 (PIZV) Zika Vaccine Dosage
TAK-426 will be administered by intramuscular injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4). Three different vaccine doses containing different protein concentrations (2, 5, or 10 micrograms [mcg]) will be given as a two-dose schedule to flavivirus naive and primed healthy adults.
TAK-426 (PIZV) Zika Vaccine News
August 26, 2019 – A recent Zika study focused on how best to eliminate the mosquito and sexual transmission of the Zika virus with a preventive vaccine.
January 29, 2018 - Takeda Pharmaceutical Company Limited announced that the U.S. FDA had granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
September 2, 2016 - Takeda announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world. Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application in the USA.
TAK-426 (PIZV) Zika Vaccine Clinical Trial
Clinical Trial NCT03343626: Safety, Immunogenicity, and Dose-Ranging Study of Inactivated Zika Virus Vaccine in 271 Healthy Adult Participants. Last Update Posted: December 16, 2020.
This multi-center trial will be conducted in the United States and Puerto Rico. The overall time to participate in this study is up to 25 months. Participants will make multiple visits to the clinic on Days 1, 8, 29, 36, 57, 211, 393. They will be contacted by telephone on Day 133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11), depending on the study arm, for a final follow-up assessment.
If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.