A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to describe the side effects and immune response of a candidate vaccine that might protect against Zika. The vaccine called PIZV (purified inactivated Zika virus vaccine) is given by injection in two doses that are 28 days apart in healthy adults. Participants will receive PIZV or placebo and will be followed for 7 days after each dose and up to 6 months after dose 2.

Key facts

Study ID

NCT05469802

Run by

Takeda

People needed

0

Starts

2024-01-02

Expected to finish

2024-07-05

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy participants.
• Participants who can comply with trial procedures (including new trial technologies) and are available for the duration of follow-up.
• All females of childbearing potential must have a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test prior to receiving any dose.

You may not qualify if…

• Participants with past or current ZIKV infection by self-report.
• Participants with past or current dengue virus, yellow fever virus, Japanese encephalitis virus, tick-borne encephalitis virus or West Nile virus infection by self-report.
• Participants who have travelled to dengue and/or Zika endemic countries and US regions and territories*, or who plan to travel to these countries/regions within 1 month prior to anticipated enrollment up to 1 month post dose 2.
• Centers for Disease Control and Prevention (CDC) website describes dengue/Zika endemic countries and US regions and territories.
• Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
• Participants with known or suspected impairment/alteration of immune function, including:
• Chronic use of oral or parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks / ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
• Receipt of immunomodulatory agents within 60 days prior to Day 1.
• Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derived products within 3 months prior to Day 1 or planned receipt during the full length of the trial. In addition, participants must be advised not to donate blood during the study period.
• Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
• Genetic immunodeficiency.
• Participants with known current or chronic hepatitis B and/or hepatitis C infections.
• Participants with abnormalities of splenic or thymic function.
• Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• Participants with any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin-dependent diabetes, cardiac, renal, hepatic or thyroid disease, uncontrolled hypertension, uncontrolled asthma).
• Participants with a history of substance or alcohol abuse within the past 2 years.

Where it is running

• CenExel Research Centers of America — Oakland Park, Florida, United States
• Velocity Clinical Research, Boise — Meridian, Idaho, United States
• AMR East Wichita, Formerly Heartland Associates East Wichita, an AMR company — Wichita, Kansas, United States
• AMR Lexington, Formerly Central Kentucky Research Associates, an AMR company — Lexington, Kentucky, United States
• Alliance for Multispecialty Research, LLC — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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