TAK-426 (PIZV) is Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
Takeda’s Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) which was last updated on March 26, 2019.
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart.
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.
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.
Clinical Trial NCT03343626: Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants