Clinical trial NCT05469802: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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 beta human chorionic gonadotropin (β-hCG) pregnancy test prior to receiving any dose.

Exclusion Criteria:

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

   Participants who have travelled to dengue and/or Zika endemic countries and US regions and territories\*, or who plan to travel to these countries/regions within 1 month prior to anticipated enrollment up to 1 month post dose 2.

   \*Centers for Disease Control and Prevention (CDC) website describes dengue/Zika endemic countries and US regions and territories.
3. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
4. Participants with known or suspected impairment/alteration of immune function, including:

   1. Chronic use of oral or parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks / ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
   2. Receipt of immunomodulatory agents within 60 days prior to Day 1.
   3. Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derived products within 3 months prior to Day 1 or planned receipt during the full length of the trial. In addition, participants must be advised not to donate blood during the study period.
   4. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
   5. Genetic immunodeficiency.
5. Participants with known current or chronic hepatitis B and/or hepatitis C infections.
6. Participants with abnormalities of splenic or thymic function.
7. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
8. Participants with any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin-dependent diabetes, cardiac, renal, hepatic or thyroid disease, uncontrolled hypertension, uncontrolled asthma).
9. Participants with a history of substance or alcohol abuse within the past 2 years.

Primary outcomes:
measure: Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
timeFrame: Within 28 days after Dose 2 (Day 57)
measure: Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
timeFrame: Within 28 days after Dose 2 (Day 57)
measure: Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
timeFrame: Within 28 days after Dose 2 (Day 57)
measure: Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After First Dose of Vaccination
timeFrame: Within 7 days after Dose 1 (Up to Day 7)
measure: Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After Second Dose of Vaccination
timeFrame: Within 7 days After Dose 2 (Days 29 to 35)
measure: Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After First Dose of Vaccination
timeFrame: Within 7 days after Dose 1 (Up to Day 7)
measure: Percentage of Participants With Solicited Systemic AEs for 7 Days After Second Dose of Vaccination
timeFrame: Within 7 days After Dose 2 (Days 29 to 35)
measure: Percentage of Participants With at Least One Unsolicited AE for 28 Days After First Dose of Vaccination
timeFrame: Within 28 days after dose 1 (Up to Day 29)
measure: Percentage of Participants With at Least One Unsolicited AE for 28 Days After Second Dose of Vaccination
timeFrame: Within 28 days after dose 2 (Days 29 to 57)
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Entire Study Period
timeFrame: From day of first vaccination (Day 1) up to end of the study (Day 211)
measure: Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) Throughout the Entire Study Period
timeFrame: From day of first vaccination (Day 1) up to end of the study (Day 211)
measure: Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) Throughout the Entire Study Period
timeFrame: From day of first vaccination (Day 1) up to end of the study (Day 211)
Secondary outcomes:
measure: Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus
timeFrame: Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
measure: Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
timeFrame: 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)
measure: Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus
timeFrame: Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
measure: Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
timeFrame: Within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211)
measure: Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus
timeFrame: Baseline (Day 1), within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211)
measure: GMTs for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
timeFrame: 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)
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE) From 28 Days up to 6 Months Post Dose 2
timeFrame: From 28 days up to 6 months post Dose 2 (Up to Day 211)
measure: Percentage of Participants With at Least One SAE in FV Exposed Participants
timeFrame: 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)
measure: Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From 28 Days up to 6 Months Post Dose 2
timeFrame: From 28 days up to 6 months post Dose 2 (Up to Day 211)
measure: Percentage of Participants With at Least One AESI in FV Exposed Participants
timeFrame: 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)
measure: Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From 28 Days up to 6 Months Post Dose 2
timeFrame: From 28 days up to 6 months post Dose 2 (Up to Day 211)
measure: Percentage of Participants With at Least One MAAE in FV Exposed Participants
timeFrame: 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)
Other outcomes:
Locations:
city: Oakland Park
country: United States
facility: CenExel Research Centers of America
state: Florida
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Wichita
country: United States
facility: AMR East Wichita, Formerly Heartland Associates East Wichita, an AMR company
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington, Formerly Central Kentucky Research Associates, an AMR company
state: Kentucky
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: