Healthy VolunteersPhase 2NCT05469802

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

A Phase 2 study testing Purified Inactivated Zika Virus Vaccine (PIZV) in people with Healthy Volunteers, run by Takeda at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Purified Inactivated Zika Virus Vaccine (PIZV)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 5 sitesUnited States
Study dates: 2 Jan 2024to 5 Jul 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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:

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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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114
AMR Lexington, Formerly Central Kentucky Research Associates, an AMR company
Lexington, Kentucky, 40509
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
CenExel Research Centers of America
Oakland Park, Florida, 33334
AMR East Wichita, Formerly Heartland Associates East Wichita, an AMR company
Wichita, Kansas, 67207

Other trials in United States

About this study

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

Read the 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.

Conditions: Healthy Volunteers
Being tested: Purified Inactivated Zika Virus Vaccine (PIZV), Placebo
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Purified Inactivated Zika Virus Vaccine (PIZV)Biological
Also called TAK-426
PIZV vaccine with aluminium hydroxide adjuvant IM injection.
PlaceboOther
Placebo (normal saline (0.9% NaCl) IM injection.

Study groups in NCT05469802
Study group	Role	What they receive
PIZV 0.5 mL	Experimental	Participants will receive PIZV 0.5 mL injection, IM, once on Day 1 (first dose) and Day 29 (second dose). Receives: Biological: Purified Inactivated Zika Virus Vaccine (PIZV)
Placebo 0.5 mL	Placebo comparator	Participants will receive a placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 28 days after Dose 2 (Day 57)
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.
Measured: Within 28 days after Dose 2 (Day 57)
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.
Measured: Within 28 days after Dose 2 (Day 57)
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.
Measured: Within 7 days after Dose 1 (Up to Day 7)
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.
Measured: Within 7 days After Dose 2 (Days 29 to 35)
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.
Measured: Within 7 days after Dose 1 (Up to Day 7)
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.
Measured: Within 7 days After Dose 2 (Days 29 to 35)
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.
Measured: Within 28 days after dose 1 (Up to Day 29)
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.
Measured: Within 28 days after dose 2 (Days 29 to 57)
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.
Measured: From day of first vaccination (Day 1) up to end of the study (Day 211)
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.
Measured: From day of first vaccination (Day 1) up to end of the study (Day 211)
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.
Measured: From day of first vaccination (Day 1) up to end of the study (Day 211)

Secondary outcomes (12)

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.
Measured: Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
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.
Measured: 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)
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.
Measured: Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
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.
Measured: Within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211)
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.
Measured: Baseline (Day 1), within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
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.
Measured: 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)
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.
Measured: From 28 days up to 6 months post Dose 2 (Up to Day 211)
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.
Measured: 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)
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.
Measured: From 28 days up to 6 months post Dose 2 (Up to Day 211)
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.
Measured: 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)
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.
Measured: From 28 days up to 6 months post Dose 2 (Up to Day 211)
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 20245 Jul 2024

First posted22 Jul 2022
Study start2 Jan 2024 (estimated)
Primary completion5 Jul 2024 (estimated)
Study completion5 Jul 2024 (estimated)

Why it stopped: Business reason, change in Zika virus epidemiology

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05469802
Sponsor's protocol ID: ZIK-201
Status last verified: Mar 2024
First submitted: 20 Jul 2022
Last updated: 13 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05469802
Acronym / sponsor ID: ZIK-201
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Business reason, change in Zika virus epidemiology
Enrolment: 0 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 2 Jan 2024 (estimated)
Primary completion: 5 Jul 2024 (estimated)
Study completion: 5 Jul 2024 (estimated)
First posted: 22 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PIZV
Placebo

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PIZV 0.5 mL	Experimental	Biological: Purified Inactivated Zika Virus Vaccine (PIZV)Participants will receive PIZV 0.5 mL injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
Placebo 0.5 mL	Placebo comparator	Other: PlaceboParticipants will receive a placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Purified Inactivated Zika Virus Vaccine (PIZV)Also: TAK-426PIZV vaccine with aluminium hydroxide adjuvant IM injection.	Biological	PIZV 0.5 mL
PlaceboPlacebo (normal saline (0.9% NaCl) IM injection.	Other	Placebo 0.5 mL

Primary outcome

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 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
Time frame: Within 28 days after Dose 2 (Day 57)
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
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.
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 7)
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
Time frame: Within 7 days After Dose 2 (Days 29 to 35)
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
Time frame: Within 7 days after Dose 1 (Up to Day 7)
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
Time frame: Within 7 days After Dose 2 (Days 29 to 35)
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
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.
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.
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 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 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
Time frame: From day of first vaccination (Day 1) up to end of the study (Day 211)
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
Time frame: From day of first vaccination (Day 1) up to end of the study (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.

12 secondary outcomes

Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus
Time frame: Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
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)
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus
Time frame: Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
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)
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus
Time frame: Baseline (Day 1), within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
GMTs for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
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)
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)
Percentage of Participants With at Least One SAE in FV Exposed Participants
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)
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)
Percentage of Participants With at Least One AESI in FV Exposed Participants
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)
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)
Percentage of Participants With at Least One MAAE in FV Exposed Participants
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)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
To obtain more information about this study, click this link.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Purified Inactivated Zika Virus Vaccine (PIZV) in people with Healthy Volunteers, run by Takeda at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.