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.
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.
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.