Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
Completed · Phase 1 · NCT03343626
Conditions: Virus, Zika, Zika Virus Disease, Flavivirus Infections, Healthy Participants
At a glance
- Research payments reported, 2025
- $25,500
- U.S. investigators named
- 2
- Sites paid
- 2
- Planned or actual enrollment
- 271
About the trial
- Sponsor
- Takeda
- Tested
- Placebo (drug), PIZV (biological)
- Dates
- Started 2017-11-13; completion 2020-11-24
- Results posted
- Yes
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 microgram \[mcg\]) 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 till 24 months post dose 2 for safety and persistence…
From ClinicalTrials.gov, last updated 2022-02-11. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Takeda Pharmaceuticals U.S.A., Inc. reported $25,500 in research payments for this study in 2025 (6 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Sajeve S. Thomas, MD Hematology & Oncology · Orlando, FL
- Heidi A. Mckean, MD Hematology & Oncology · Sioux Falls, SD
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.