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Trial record 1 of 2 for:    takeda | Zika
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A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05469802
Recruitment Status : Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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. In addition, participants who received only PIZV will receive a booster dose of PIZV or placebo at 6 months after dose 2 and will be followed 12 months after dose 2.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Purified Inactivated Zika Virus Vaccine (PIZV) Other: Placebo Phase 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 156 healthy participants in a staggered manner stratified by age groups: Group A (≥18 to <50 years) and Group B (≥50 to <65 years), in a 2-dose Vaccination Period followed by a Booster Period. Participants will be randomly assigned (by chance, like flipping a coin) to either PIZV or placebo in each group and period-which will remain undisclosed to the study observer during the study:

  • Group A: ≥18 to <50 years
  • Group B: ≥50 to <65 years

Participants will be randomized into 2:1 to receive placebo or PIZV 0.5 ml intramuscular injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 2). Participants who receive PIZV 0.5 ml in the 2-dose Vaccination Period will be re-randomized to receive placebo or PIZV 0.5 ml in the Booster Period. 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), and medically-attended AEs (MAAEs) 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 to 13 months.

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of the Purified Inactivated Zika Virus Vaccine (PIZV) Administered on Day 1 and 29 and of a Single Booster Dose of PIZV Administered at 6 Months Post Dose 2 in Healthy Subjects Aged 18 to 65 Years in the US
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : November 22, 2024
Estimated Study Completion Date : November 22, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 2-Dose Vaccination Period: Group A (≥18 to <50 years): Placebo
Participants of age ≥18 to <50 years will be randomized to receive placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose) in the 2-Dose Vaccination Period.
 Other: Placebo
Placebo (normal saline (0.9% NaCl) IM injection.
Experimental: 2-Dose Vaccination Period: Group A (≥18 to <50 years): PIZV 0.5 ml
Participants of age ≥18 to <50 years will be randomized to receive PIZV 0.5 ml injection, IM, once on Day 1 (first dose) and Day 29 (second dose) followed by a booster period, in the 2-Dose Vaccination Period.
 Biological: Purified Inactivated Zika Virus Vaccine (PIZV)
PIZV vaccine with aluminium hydroxide adjuvant IM injection.
Other Name: TAK-426
Placebo Comparator: 2-Dose Vaccination Period: Group B (≥50 to <65 years): Placebo
Participants of age ≥50 to <65 years will be randomized to receive placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose) in the 2-Dose Vaccination Period.
 Other: Placebo
Placebo (normal saline (0.9% NaCl) IM injection.
Experimental: 2-Dose Vaccination Period: Group B (≥50 to <65 years): PIZV 0.5 ml
Participants of age ≥50 to <65 years will be randomized to receive PIZV 0.5 ml injection, IM, once on Day 1 (first dose) and Day 29 (second dose) followed by a booster period, in the 2-Dose Vaccination Period.
 Biological: Purified Inactivated Zika Virus Vaccine (PIZV)
PIZV vaccine with aluminium hydroxide adjuvant IM injection.
Other Name: TAK-426
Placebo Comparator: Booster Period: Group A (≥18 to <50 years): Placebo
Participants of age ≥18 to <50 years who received PIZV 0.5 ml in the 2-Dose Vaccination Period will be re-randomized to receive placebo injection, IM, once on Day 211 in Booster Period.
 Other: Placebo
Placebo (normal saline (0.9% NaCl) IM injection.
Experimental: Booster Period: Group A (≥18 to <50 years): PIZV 0.5 ml
Participants of age ≥18 to <50 years who received PIZV 0.5 ml in the 2-Dose Vaccination Period will be re-randomized to receive PIZV 0.5 ml, IM, once on Day 211 in Booster Period.
 Biological: Purified Inactivated Zika Virus Vaccine (PIZV)
PIZV vaccine with aluminium hydroxide adjuvant IM injection.
Other Name: TAK-426
Placebo Comparator: Booster Period: Group B (≥50 to <65 years): Placebo
Participants of age ≥50 to <65 years who received PIZV 0.5 ml in the 2-Dose Vaccination Period will be re-randomized to receive placebo injection, IM, once on Day 211 in Booster Period.
 Other: Placebo
Placebo (normal saline (0.9% NaCl) IM injection.
Experimental: Booster Period: Group B (≥50 to <65 years): PIZV 0.5 ml
Participants of age ≥50 to <65 years who received PIZV 0.5 ml in the 2-Dose Vaccination Period will be re-randomized to receive PIZV 0.5 ml, IM, once on Day 211 in Booster Period.
 Biological: Purified Inactivated Zika Virus Vaccine (PIZV)
PIZV vaccine with aluminium hydroxide adjuvant IM injection.
Other Name: TAK-426


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2 [ Time Frame: Within 28 days after Dose 2 (Day 57) ]
    Seropositive participants are defined as participants with detectable (tested positive at or above the limit of detection [LOD]) serum neutralizing anti-ZIKV antibodies. Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only, and participants in the overall age range (≥18 to <65 years).

  2. Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2 [ Time Frame: Within 28 days after Dose 2 (Day 57) ]
    Seroconverted participants are seronegative participants at pre-vaccination time point with detectable (tested positive at or above LOD) post-vaccination serum neutralizing anti-ZIKV antibodies, and seropositive participants at pre-vaccination time point with defined post-vaccination increases (from pre-vaccination values) in serum neutralizing anti-ZIKV antibodies. The fold increase that is meaningful will be based on the assay performance and provided in the statistical analysis plan (SAP). Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only, and participants in the overall age range (≥18 to <65 years).

  3. Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2 [ Time Frame: Within 28 days after Dose 2 (Day 57) ]
    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, and participants in the overall age range (≥18 to <65 years).

  4. Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After First Dose of Vaccination [ Time Frame: Within 7 days after Dose 1 (Up to Day 8) ]
    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, participants in the overall age range (≥18 to <65 years), and by age stratum.

  5. Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After Second Dose of Vaccination [ Time Frame: Within 7 days After Dose 2 (Days 29 to 36) ]
    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, participants in the overall age range (≥18 to <65 years), and by age stratum.

  6. Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination After First Dose of Vaccination [ Time Frame: Within 7 days after Dose 1 (Up to Day 8) ]
    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/>10°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, participants in the overall age range (≥18 to <65 years), and by age stratum.

  7. Percentage of Participants With Solicited Systemic AEs for 7 Days After Second Dose of Vaccination [ Time Frame: Within 7 days After Dose 2 (Days 29 to 36) ]
    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/>10°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, participants in the overall age range (≥18 to <65 years), and by age stratum.

  8. Percentage of Participants With at Least One Unsolicited AE for 28 Days After First Dose of Vaccination [ Time Frame: Within 28 days after dose 1 (Up to Day 29) ]
    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, participants in the overall age range (≥18 to <65 years) and by age stratum.

  9. Percentage of Participants With at Least One Unsolicited AE for 28 Days After Second Dose of Vaccination [ Time Frame: Within 28 days after dose 2 (Days 29 to 57) ]
    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, participants in the overall age range (≥18 to <65 years) and by age stratum.

  10. Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Entire Study Period [ Time Frame: From day of first vaccination (Day 1) up to end of the study (Day 393) ]
    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 medically important 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, participants in the overall age range (≥18 to <65 years) and by age stratum.

  11. Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) Throughout the Entire Study Period [ Time Frame: From day of first vaccination (Day 1) up to end of the study (Day 393) ]
    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, participants in the overall age range (≥18 to <65 years) and by age stratum.

  12. Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) Throughout the Entire Study Period [ Time Frame: From day of first vaccination (Day 1) up to end of the study (Day 393) ]
    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, participants in the overall age range (≥18 to <65 years) and by age stratum.


Secondary Outcome Measures :
  1. Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211) ]
    Seropositive participants are defined as participants with detectable (tested positive at or above the limit of detection [LOD]) serum neutralizing anti-ZIKV antibodies. Data will be reported for the overall study population and in FV naïve participants only, by age stratum, as well as in FV primed participants only, in the overall age range (≥18 to <65 years).

  2. Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211) ]
    Seroconverted participants are seronegative participants at pre-vaccination time point with detectable (tested positive at or above LOD) post-vaccination serum neutralizing anti-ZIKV antibodies, and seropositive participants at pre-vaccination time point with defined post-vaccination increases (from pre-vaccination values) in serum neutralizing anti-ZIKV antibodies. The fold increase that is meaningful will be based on the assay performance and provided in the SAP. Data will be reported for the overall study population and in FV naïve participants only, by age stratum, as well as in FV primed participants only, in the overall age range (≥18 to <65 years).

  3. Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211) ]
    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, by age stratum, as well as in FV primed participants only, in the overall age range (≥18 to <65 years)

  4. Percentage of Participants With at Least One Serious Adverse Event (SAE) From 28 Days up to 6 Months Post Dose 2 [ Time Frame: From 28 days up to 6 months post Dose 2 (Up to Day 211) ]
    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 medically important 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, in all age ranges (≥18 to <65 years) and by age stratum.

  5. Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From 28 Days up to 6 Months Post Dose 2 [ Time Frame: From 28 days up to 6 months post Dose 2 (Up to Day 211) ]
    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, participants in the overall age range (≥18 to <65 years) and by age stratum.

  6. Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From 28 Days up to 6 Months Post Dose 2 [ Time Frame: From 28 days up to 6 months post Dose 2 (Up to Day 211) ]
    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, participants in the overall age range (≥18 to <65 years) and by age stratum.

  7. Percentage of Subset of Participants Who Received the Booster Dose With Seropositivity for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 7 days post Booster Dose (Day 218) ]
    Seropositive participants are defined as participants with detectable (tested positive at or above the limit of detection [LOD]) serum neutralizing anti-ZIKV antibodies.

  8. Percentage of Participants Who Received the Booster Dose With Seropositivity for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 28 days post Booster Dose (Day 239) and 6 months after Booster Dose (Day 393) ]
    Seropositive participants are defined as participants with detectable (tested positive at or above the limit of detection [LOD]) serum neutralizing anti-ZIKV antibodies. Data will be reported for all participants at 28 days post booster dose and for overall study population and in FV naïve participants only; overall (≥18 to <65 years) and by age stratum at 6 months post dose.

  9. Percentage of Subset of Participants Who Received the Booster Dose With Seroconversion for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 7 days post Booster Dose (Day 218) ]
    Seroconverted participants are seronegative participants at pre-vaccination time point with detectable (tested positive at or above LOD) post-vaccination serum neutralizing anti-ZIKV antibodies, and seropositive participants at pre-vaccination time point with defined post-vaccination increases (from pre-vaccination values) in serum neutralizing anti-ZIKV antibodies.

  10. Percentage of Participants Who Received the Booster Dose With Seroconversion for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 28 days post Booster Dose (Day 239) and 6 months post Booster Dose (Day 393) ]
    Seroconverted participants are seronegative participants at pre-vaccination time point with detectable (tested positive at or above LOD) post-vaccination serum neutralizing anti-ZIKV antibodies, and seropositive participants at pre-vaccination time point with defined post-vaccination increases (from pre-vaccination values) in serum neutralizing anti-ZIKV antibodies. Data will be reported for all participants at 28 days post booster dose and for overall study population and in FV naïve participants only; overall (≥18 to <65 years) and by age stratum at 6 months post dose.

  11. Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus in Participants Who Received the Booster Dose [ Time Frame: Within 7 days post Booster Dose (Day 218) ]
    GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV.

  12. Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus [ Time Frame: Within 28 days post Booster Dose (Day 239) and 6 months post Booster Dose (Day 393) ]
    GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for all participants at 28 days post booster dose and for overall study population and in FV naïve participants only; overall (≥18 to <65 years) and by age stratum at 6 months post dose.

  13. Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against Zika Virus Compared to Pre-Booster Dose in Participants Who Received a Booster Dose [ Time Frame: Within 7 days before Booster Dose (Day 204) ]
  14. Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against Zika Virus Compared to Pre-Booster Dose [ Time Frame: Within 7 days before Booster Dose (Day 204) ]
    Data will be reported for all participants at 28 days post booster dose and for overall study population and in FV naïve participants only; overall (≥18 to <65 years) and by age stratum at 6 months post dose.

  15. Percentage of Participants With Solicited Local Injection Site Reactions by Severity During the 7-day Period Post Booster [ Time Frame: Within 7 days post Booster Dose (Day 218) ]
    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 and FV primed participants only, overall (≥18 to <65 years) and by age stratum (FV naïve only).

  16. Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity During the 6-day Period Post Booster [ Time Frame: Within 6 days post Booster Dose (Day 217) ]
    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/>10°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 and FV primed participants only, overall (≥18 to <65 years) and by age stratum (FV naïve only).

  17. Percentage of Participants With Unsolicited AE During the 28-day Period Post Booster [ Time Frame: Within 28 days post Booster Dose (Day 239) ]
    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 and FV primed participants only, overall (≥18 to <65 years) and by age stratum (FV naïve only).

  18. Percentage of Participants With at Least One Serious Adverse Event (SAE) From Booster Administration Until End of Study Period [ Time Frame: Post Booster Dose up to end of study (From Day 211 to Day 393) ]
    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 medically important 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 and FV primed participants only, overall (≥18 to <65 years) and by age stratum (FV naïve only).

  19. Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From Booster Administration Until End of Study [ Time Frame: Post Booster Dose up to end of study (From Day 211 to Day 393) ]
    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 and FV primed participants only, overall (≥18 to <65 years) and by age stratum (FV naïve only).

  20. Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From Booster Administration Until End of Study Period [ Time Frame: Post Booster Dose up to end of study (From Day 211 to Day 393) ]
    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 and FV primed participants only, overall (≥18 to <65 years) and by age stratum (FV naïve only).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05469802


Contacts
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Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
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United States, Florida
CenExel Research Centers of America
Oakland Park, Florida, United States, 33334
Contact: Site Contact    954-990-7649    howard.schwartz@rcatrials.com   
Principal Investigator: Howard Schwartz         
United States, Idaho
Velocity Clinical Research, Boise
Meridian, Idaho, United States, 83642
Contact: Site Contact    208-377-8653    mturner@velocityclinical.com; movetoflorida8@gmail.com   
Principal Investigator: Mark Turner         
United States, Kansas
AMR East Wichita, Formerly Heartland Associates East Wichita, an AMR company
Wichita, Kansas, United States, 67207
Contact: Site Contact    316-689-6683    terry.poling@amrllc.com   
Principal Investigator: Terry Poling         
United States, Kentucky
AMR Lexington, Formerly Central Kentucky Research Associates, an AMR company
Lexington, Kentucky, United States, 40509
Contact: Site Contact    859-977-7151    mark.adams@amrllc.com   
Principal Investigator: Mark Adams         
United States, Missouri
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States, 64114
Contact: Site Contact    816-943-0770    john.ervin@amrllc.com   
Principal Investigator: John Ervin         
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
More Information
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Additional Information:

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT05469802    
Other Study ID Numbers: ZIK-201
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/

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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
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Zika Virus Infection
Arbovirus Infections
Vector Borne Diseases
Infections
 Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections