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.