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

Primary Purpose

Healthy Volunteers

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Purified Inactivated Zika Virus Vaccine (PIZV)
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Volunteers focused on measuring Drug Therapy

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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 β-hCG pregnancy test prior to receiving any dose including the booster.

Exclusion Criteria:

  1. Participants with past or current ZIKV infection by self-report.
  2. Participants with past or current dengue virus (DENV), yellow fever virus, Japanese encephalitis virus, tick-borne encephalitis virus or West Nile virus infection by self-report.

  3. Participants who have travelled to flavivirus (FV)-endemic countries and US regions and territories*, or who plan to travel to these countries/regions within:

    • 1 month prior to anticipated enrolment up to 1 month post dose 2.

    And, if applicable:

    • 1 month prior to up to 1 month after anticipated booster dose.

    *Centers for Disease Control and Prevention (CDC) website describes FV-endemic countries and US regions and territories.

  4. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuroinflammatory disease (e.g., Guillain-Barré syndrome).

  5. 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.
  6. Participants with known current or chronic hepatitis B and/or hepatitis C infections.
  7. Participants with abnormalities of splenic or thymic function.
  8. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  9. 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).
  10. Participants with a history of substance or alcohol abuse within the past 2 years.

Booster Criteria:

  1. Participants continue to meet the initial trial inclusion and exclusion criteria
  2. Participants received 2 doses of PIZV (not placebo) during the 2-dose Vaccination Period.
  3. Participants whose personal safety data during the 2-dose Vaccination Period do not preclude them from receiving a booster dose in the opinion of the investigator.

Sites / Locations

  • CenExel Research Centers of America
  • Velocity Clinical Research, Boise
  • AMR East Wichita, Formerly Heartland Associates East Wichita, an AMR company
  • AMR Lexington, Formerly Central Kentucky Research Associates, an AMR company
  • Alliance for Multispecialty Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PIZV 0.5 mL

Placebo 0.5 mL

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
Seropositive participants are defined as participants with quantifiable (tested positive at or above the limit of quantitation [LOQ]) serum neutralizing anti-Zika virus (ZIKV) antibodies. Data will be reported for the overall study population (regardless of pre-vaccination flavivirus (FV) serostatus) and in FV naïve participants only.
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
Seroconversion is defined as the percentage of participants with either pre-vaccination titer <LOQ and a post-vaccination titer ≥4xLOQ; or a pre-vaccination titer ≥LOQ and a 4-fold increase in titer post vaccination. Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only.
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only.
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After First Dose of Vaccination
Solicited local AEs (at injection site) included pain/tenderness (mild: mild discomfort to touch, moderate: discomfort with movement, severe: significant discomfort at rest, potentially life-threatening: emergency room [ER] visit or hospitalization), erythema/redness (mild: 2.5 - 5 cm, moderate: 5.1 - 10 cm, severe: > 10 cm, potentially life-threatening: necrosis or exfoliative dermatitis), and swelling/induration (mild: 2.5 - 5 cm and does not interfere with activity, moderate: 5.1 - 10 cm or interferes with activity, severe: > 10 cm or prevents daily activity, potentially life-threatening: Necrosis). Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After Second Dose of Vaccination
Solicited local AEs (at injection site) included pain/tenderness (mild: mild discomfort to touch, moderate: discomfort with movement, severe: significant discomfort at rest, potentially life-threatening: ER visit or hospitalization), erythema/redness (mild: 2.5 - 5 cm, moderate: 5.1 - 10 cm, severe: > 10 cm, potentially life-threatening: necrosis or exfoliative dermatitis), and swelling/induration (mild: 2.5 - 5 cm and does not interfere with activity, moderate: 5.1 - 10 cm or interferes with activity, severe: > 10 cm or prevents daily activity, potentially life-threatening: Necrosis). Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After First Dose of Vaccination
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs will be graded from 1(mild) to 4(potentially life threatening) by severity. Fever: Grade 1(mild)= 38.0-38.4 degrees Celsius(°C)/100.4-101.1 degrees Fahrenheit (°F), Grade 2(moderate)=38.5-38.9°C/101.2-102.0°F, Grade 3(severe)=39.0-40°C/102.1-104°F, Grade 4 (potentially life threatening)=>40°C/>104°F. Headache, fatigue, malaise, arthralgia, and myalgia: Grade 1=no interference with activity, Grade 2=some interference with activity(Headache: repeated use of non-narcotic pain reliever>24 hours or some interference with activity), Grade 3 =significant; prevents daily activity(Headache: significant; any use of narcotic pain reliever or prevents daily activity), and Grade 4=ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With Solicited Systemic AEs for 7 Days After Second Dose of Vaccination
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs will be graded from 1(mild) to 4(potentially life threatening) by severity. Fever: Grade 1(mild)= 38.0-38.4°C/100.4-101.1°F, Grade 2(moderate)=38.5-38.9°C/101.2-102.0°F, Grade 3(severe)=39.0-40°C/102.1-104°F, Grade 4 (potentially life threatening)=>40°C/>104°F. Headache, fatigue, malaise, arthralgia, and myalgia: Grade 1=no interference with activity, Grade 2=some interference with activity(Headache: repeated use of non-narcotic pain reliever>24 hours or some interference with activity), Grade 3 =significant; prevents daily activity(Headache: significant; any use of narcotic pain reliever or prevents daily activity), and Grade 4=ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One Unsolicited AE for 28 Days After First Dose of Vaccination
An unsolicited AE is any AE reported by the participant that is either not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting solicited AE (ie, 7 days in total including the day of PIZV or placebo administration). Unsolicited AEs will be graded from 1 to 4 by severity, where Grade 1 (mild)= no interference with activity, Grade 2 (moderate)= some interference with activity, Grade 3 (severe)= significant; prevents daily activity, and Grade 4 (potentially life threatening)= ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One Unsolicited AE for 28 Days After Second Dose of Vaccination
An unsolicited AE is any AE reported by the participant that is either not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting solicited AE (ie, 7 days in total including the day of PIZV or placebo administration). Unsolicited AEs will be graded from 1 to 4 by severity, where Grade 1 (mild)= no interference with activity, Grade 2 (moderate)= some interference with activity, Grade 3 (severe)= significant; prevents daily activity, and Grade 4 (potentially life threatening)= ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Entire Study Period
An SAE will be defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an important medical event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) Throughout the Entire Study Period
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an PIZV or placebo; it does not necessarily have to have a causal relationship with PIZV or placebo administration. AESI is defined as an AE collected through the study period and entered in the eCRF by the investigator or designee within 24 hours of becoming aware of the event which includes new onset of or worsening of the following neurologic diseases: Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions, and anaphylaxis. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) Throughout the Entire Study Period
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Data will be reported for the overall study population and in FV naïve participants only.

Secondary Outcome Measures

Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus
Seropositive participants are defined as participants with quantifiable (tested positive at or above the LOQ) serum neutralizing anti-ZIKV antibodies. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
Seropositive participants are defined as participants with quantifiable (tested positive at or above the LOQ) serum neutralizing anti-ZIKV antibodies. Data will be reported for FV exposed participants only.
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus
Seroconversion is defined as the percentage of participants with either pre-vaccination titer <LOQ and a post-vaccination titer ≥4xLOQ; or a pre-vaccination titer ≥LOQ and a 4-fold increase in titer post vaccination. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
Seroconversion is defined as the percentage of participants with either pre-vaccination titer <LOQ and a post-vaccination titer ≥4xLOQ; or a pre-vaccination titer ≥LOQ and a 4-fold increase in titer post vaccination. Data will be reported for FV exposed participants only.
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for the overall study population and in FV naïve participants only.
GMTs for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for FV exposed participants only.
Percentage of Participants With at Least One Serious Adverse Event (SAE) From 28 Days up to 6 Months Post Dose 2
An SAE will be defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an important medical event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One SAE in FV Exposed Participants
An SAE will be defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an important medical event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Data will be reported for FV exposed participants only.
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From 28 Days up to 6 Months Post Dose 2
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. An AE will be considered AESI if any participant experiences a new onset of or worsening of the following neurologic diseases: GBS, acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions and/or anaphylaxis. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One AESI in FV Exposed Participants
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. An AE will be considered AESI if any participant experiences a new onset of or worsening of the following neurologic diseases: GBS, acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions and/or anaphylaxis. Data will be reported for FV exposed participants only.
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From 28 Days up to 6 Months Post Dose 2
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Data will be reported for the overall study population and in FV naïve participants only.
Percentage of Participants With at Least One MAAE in FV Exposed Participants
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Data will be reported for FV exposed participants only.

Full Information

First Posted
July 20, 2022
Last Updated
October 17, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT05469802
Brief Title
A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults
Official Title
A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Immunogenicity of the Purified Inactivated Zika Virus Vaccine (PIZV) Administered on Days 1 and 29 in Healthy Participants Aged 18 to 49 Years in the US
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2, 2024 (Anticipated)
Primary Completion Date
July 5, 2024 (Anticipated)
Study Completion Date
July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIZV 0.5 mL
Arm Type
Experimental
Arm Description
Participants will receive PIZV 0.5 mL injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
Arm Title
Placebo 0.5 mL
Arm Type
Placebo Comparator
Arm Description
Participants will receive a placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
Intervention Type
Biological
Intervention Name(s)
Purified Inactivated Zika Virus Vaccine (PIZV)
Other Intervention Name(s)
TAK-426
Intervention Description
PIZV vaccine with aluminium hydroxide adjuvant IM injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (normal saline (0.9% NaCl) IM injection.
Primary Outcome Measure Information:
Title
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
Description
Seropositive participants are defined as participants with quantifiable (tested positive at or above the limit of quantitation [LOQ]) serum neutralizing anti-Zika virus (ZIKV) antibodies. Data will be reported for the overall study population (regardless of pre-vaccination flavivirus (FV) serostatus) and in FV naïve participants only.
Time Frame
Within 28 days after Dose 2 (Day 57)
Title
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
Description
Seroconversion is defined as the percentage of participants with either pre-vaccination titer <LOQ and a post-vaccination titer ≥4xLOQ; or a pre-vaccination titer ≥LOQ and a 4-fold increase in titer post vaccination. Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only.
Time Frame
Within 28 days after Dose 2 (Day 57)
Title
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
Description
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only.
Time Frame
Within 28 days after Dose 2 (Day 57)
Title
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After First Dose of Vaccination
Description
Solicited local AEs (at injection site) included pain/tenderness (mild: mild discomfort to touch, moderate: discomfort with movement, severe: significant discomfort at rest, potentially life-threatening: emergency room [ER] visit or hospitalization), erythema/redness (mild: 2.5 - 5 cm, moderate: 5.1 - 10 cm, severe: > 10 cm, potentially life-threatening: necrosis or exfoliative dermatitis), and swelling/induration (mild: 2.5 - 5 cm and does not interfere with activity, moderate: 5.1 - 10 cm or interferes with activity, severe: > 10 cm or prevents daily activity, potentially life-threatening: Necrosis). Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 7 days after Dose 1 (Up to Day 7)
Title
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After Second Dose of Vaccination
Description
Solicited local AEs (at injection site) included pain/tenderness (mild: mild discomfort to touch, moderate: discomfort with movement, severe: significant discomfort at rest, potentially life-threatening: ER visit or hospitalization), erythema/redness (mild: 2.5 - 5 cm, moderate: 5.1 - 10 cm, severe: > 10 cm, potentially life-threatening: necrosis or exfoliative dermatitis), and swelling/induration (mild: 2.5 - 5 cm and does not interfere with activity, moderate: 5.1 - 10 cm or interferes with activity, severe: > 10 cm or prevents daily activity, potentially life-threatening: Necrosis). Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 7 days After Dose 2 (Days 29 to 35)
Title
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After First Dose of Vaccination
Description
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs will be graded from 1(mild) to 4(potentially life threatening) by severity. Fever: Grade 1(mild)= 38.0-38.4 degrees Celsius(°C)/100.4-101.1 degrees Fahrenheit (°F), Grade 2(moderate)=38.5-38.9°C/101.2-102.0°F, Grade 3(severe)=39.0-40°C/102.1-104°F, Grade 4 (potentially life threatening)=>40°C/>104°F. Headache, fatigue, malaise, arthralgia, and myalgia: Grade 1=no interference with activity, Grade 2=some interference with activity(Headache: repeated use of non-narcotic pain reliever>24 hours or some interference with activity), Grade 3 =significant; prevents daily activity(Headache: significant; any use of narcotic pain reliever or prevents daily activity), and Grade 4=ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 7 days after Dose 1 (Up to Day 7)
Title
Percentage of Participants With Solicited Systemic AEs for 7 Days After Second Dose of Vaccination
Description
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs will be graded from 1(mild) to 4(potentially life threatening) by severity. Fever: Grade 1(mild)= 38.0-38.4°C/100.4-101.1°F, Grade 2(moderate)=38.5-38.9°C/101.2-102.0°F, Grade 3(severe)=39.0-40°C/102.1-104°F, Grade 4 (potentially life threatening)=>40°C/>104°F. Headache, fatigue, malaise, arthralgia, and myalgia: Grade 1=no interference with activity, Grade 2=some interference with activity(Headache: repeated use of non-narcotic pain reliever>24 hours or some interference with activity), Grade 3 =significant; prevents daily activity(Headache: significant; any use of narcotic pain reliever or prevents daily activity), and Grade 4=ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 7 days After Dose 2 (Days 29 to 35)
Title
Percentage of Participants With at Least One Unsolicited AE for 28 Days After First Dose of Vaccination
Description
An unsolicited AE is any AE reported by the participant that is either not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting solicited AE (ie, 7 days in total including the day of PIZV or placebo administration). Unsolicited AEs will be graded from 1 to 4 by severity, where Grade 1 (mild)= no interference with activity, Grade 2 (moderate)= some interference with activity, Grade 3 (severe)= significant; prevents daily activity, and Grade 4 (potentially life threatening)= ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 28 days after dose 1 (Up to Day 29)
Title
Percentage of Participants With at Least One Unsolicited AE for 28 Days After Second Dose of Vaccination
Description
An unsolicited AE is any AE reported by the participant that is either not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting solicited AE (ie, 7 days in total including the day of PIZV or placebo administration). Unsolicited AEs will be graded from 1 to 4 by severity, where Grade 1 (mild)= no interference with activity, Grade 2 (moderate)= some interference with activity, Grade 3 (severe)= significant; prevents daily activity, and Grade 4 (potentially life threatening)= ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 28 days after dose 2 (Days 29 to 57)
Title
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Entire Study Period
Description
An SAE will be defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an important medical event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
From day of first vaccination (Day 1) up to end of the study (Day 211)
Title
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) Throughout the Entire Study Period
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an PIZV or placebo; it does not necessarily have to have a causal relationship with PIZV or placebo administration. AESI is defined as an AE collected through the study period and entered in the eCRF by the investigator or designee within 24 hours of becoming aware of the event which includes new onset of or worsening of the following neurologic diseases: Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions, and anaphylaxis. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
From day of first vaccination (Day 1) up to end of the study (Day 211)
Title
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) Throughout the Entire Study Period
Description
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
From day of first vaccination (Day 1) up to end of the study (Day 211)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus
Description
Seropositive participants are defined as participants with quantifiable (tested positive at or above the LOQ) serum neutralizing anti-ZIKV antibodies. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
Title
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
Description
Seropositive participants are defined as participants with quantifiable (tested positive at or above the LOQ) serum neutralizing anti-ZIKV antibodies. Data will be reported for FV exposed participants only.
Time Frame
Baseline (Day 1), within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211)
Title
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus
Description
Seroconversion is defined as the percentage of participants with either pre-vaccination titer <LOQ and a post-vaccination titer ≥4xLOQ; or a pre-vaccination titer ≥LOQ and a 4-fold increase in titer post vaccination. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
Title
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
Description
Seroconversion is defined as the percentage of participants with either pre-vaccination titer <LOQ and a post-vaccination titer ≥4xLOQ; or a pre-vaccination titer ≥LOQ and a 4-fold increase in titer post vaccination. Data will be reported for FV exposed participants only.
Time Frame
Within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211)
Title
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus
Description
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
Baseline (Day 1), within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
Title
GMTs for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
Description
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for FV exposed participants only.
Time Frame
Baseline (Day 1), within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211)
Title
Percentage of Participants With at Least One Serious Adverse Event (SAE) From 28 Days up to 6 Months Post Dose 2
Description
An SAE will be defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an important medical event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
From 28 days up to 6 months post Dose 2 (Up to Day 211)
Title
Percentage of Participants With at Least One SAE in FV Exposed Participants
Description
An SAE will be defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an important medical event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Data will be reported for FV exposed participants only.
Time Frame
Within 28 days post Dose 1 (Day 29), 28 days post Dose 2 (Day 57) and 6 months post Dose 2 (Up to Day 211)
Title
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From 28 Days up to 6 Months Post Dose 2
Description
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. An AE will be considered AESI if any participant experiences a new onset of or worsening of the following neurologic diseases: GBS, acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions and/or anaphylaxis. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
From 28 days up to 6 months post Dose 2 (Up to Day 211)
Title
Percentage of Participants With at Least One AESI in FV Exposed Participants
Description
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. An AE will be considered AESI if any participant experiences a new onset of or worsening of the following neurologic diseases: GBS, acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions and/or anaphylaxis. Data will be reported for FV exposed participants only.
Time Frame
Within 28 days post Dose 1 (Day 29), 28 days post Dose 2 (Day 57) and 6 months post Dose 2 (Up to Day 211)
Title
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From 28 Days up to 6 Months Post Dose 2
Description
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Data will be reported for the overall study population and in FV naïve participants only.
Time Frame
From 28 days up to 6 months post Dose 2 (Up to Day 211)
Title
Percentage of Participants With at Least One MAAE in FV Exposed Participants
Description
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Data will be reported for FV exposed participants only.
Time Frame
Within 28 days post Dose 1 (Day 29), 28 days post Dose 2 (Day 57) and 6 months post Dose 2 (Up to Day 211)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
CenExel Research Centers of America
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
954-990-7649
Email
howard.schwartz@rcatrials.com
First Name & Middle Initial & Last Name & Degree
Howard Schwartz
Facility Name
Velocity Clinical Research, Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
208-377-8653
Email
mturner@velocityclinical.com; movetoflorida8@gmail.com
First Name & Middle Initial & Last Name & Degree
Mark Turner
Facility Name
AMR East Wichita, Formerly Heartland Associates East Wichita, an AMR company
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
316-689-6683
Email
terry.poling@amrllc.com
First Name & Middle Initial & Last Name & Degree
Terry Poling
Facility Name
AMR Lexington, Formerly Central Kentucky Research Associates, an AMR company
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
859-977-7151
Email
mark.adams@amrllc.com
First Name & Middle Initial & Last Name & Degree
Mark Adams
Facility Name
Alliance for Multispecialty Research, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
816-943-0770
Email
john.ervin@amrllc.com
First Name & Middle Initial & Last Name & Degree
John Ervin

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/959a893ca7334342?idFilter=%5B%22ZIK-201%22%5D
Description
To obtain more information about this study, click this link.

Learn more about this trial

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

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