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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-07-05

Brief Summary

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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.

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Detailed Description

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The candidate vaccine being tested in this study is called PIZV (purified inactivated zika virus vaccine) or TAK-426. This study will look at the safety and immunogenicity of PIZV in healthy participants.

The study will enroll approximately 78 healthy participants (≥18 to 49 years) following a 2-dose vaccination schedule. Participants will be randomly assigned (by chance, like flipping a coin) in a 2:1 ratio to either PIZV or placebo which will remain undisclosed to the study observer during the study:

* PIZV
* Placebo

Participants will receive PIZV or placebo 0.5 mL 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 3). The seropositivity rate, seroconversion rate, and geometric-mean titers will be measured 28 days post dose 2. Solicited local reactions and systemic adverse events (AEs) will be assessed for 7 days after each vaccination. Unsolicited AEs will be assessed for 28 days after each vaccination and serious AEs (SAEs), AEs of special interest (AESIs), medically-attended AEs (MAAEs), and AEs leading to withdrawal from the trial throughout the entire study period.

This multi-center trial will be conducted in the United States (US). Trial participants will be in this study for 7 months.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PIZV 0.5 mL

Participants will receive PIZV 0.5 mL injection, IM, once on Day 1 (first dose) and Day 29 (second dose).

Group Type EXPERIMENTAL

Purified Inactivated Zika Virus Vaccine (PIZV)

Intervention Type BIOLOGICAL

PIZV vaccine with aluminium hydroxide adjuvant IM injection.

Placebo 0.5 mL

Participants will receive a placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo (normal saline (0.9% NaCl) IM injection.

Interventions

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Purified Inactivated Zika Virus Vaccine (PIZV)

PIZV vaccine with aluminium hydroxide adjuvant IM injection.

Intervention Type BIOLOGICAL

Placebo

Placebo (normal saline (0.9% NaCl) IM injection.

Intervention Type OTHER

Other Intervention Names

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TAK-426

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Participants with past or current ZIKV infection by self-report.
2. 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.
3. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
4. Participants with known or suspected impairment/alteration of immune function, including:

1. 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).
2. Receipt of immunomodulatory agents within 60 days prior to Day 1.
3. 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.
4. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
5. Genetic immunodeficiency.
5. Participants with known current or chronic hepatitis B and/or hepatitis C infections.
6. Participants with abnormalities of splenic or thymic function.
7. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
8. 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).
9. Participants with a history of substance or alcohol abuse within the past 2 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes