TAK-426 (PIZV) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
TAK-426 is a vaccine candidate to prevent Zika virus.
TAK-426 will be administered by an intramuscular (IM) 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]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults.
January 29, 2018, Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has 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 (ASPR) 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 ASPR/BARDA exercises all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application (BLA) in the US.
- The Zika virus was first reported in continental South America in Brazil in May 2015.
- In February 2016, between 440,000 and 1,300,000 people were infected in Brazil.
- In the US, about 225 Zika virus cases were reported in August 2017.
- In addition, 554 cases were reported in people infected through local mosquito-borne transmission. Furthermore, autochthonous Zika virus transmission was reported in 25 countries in the Americas, Africa, and Asia.
- In 2016, it was estimated that there were between 508 and 1,778 imported cases in Europe, particularly in France, Portugal, and Italy.
Clinical Trial NCT03343626: Safety, Immunogenicity and Dose-Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants
- The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine TAK-426 (PIZV) given 28 days apart.
- Participants will be followed for 7 days post each dose for tolerability and up to 6 months post-dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post-dose 2.
- In addition, the selected dose group and control group will be followed 24 months post-dose 2 for safety and persistence of immunity.
- If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.