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Virus Vaccine
Zika Virus Vaccine for Healthy Adults
Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 28 days up to 6 months post dose 2 (up to day 211)
Awards & highlights
Study Summary
This trial is testing the side effects and effectiveness of a possible Zika virus vaccine.
Who is the study for?
Healthy adults who can follow the trial procedures and are available for all follow-ups. Women of childbearing age must test negative for pregnancy. People with past/current Zika infection, travel to Zika regions, immune function issues, certain medication use, HIV, hepatitis B/C, or serious chronic diseases cannot participate.Check my eligibility
What is being tested?
The study is testing a vaccine called PIZV against Zika virus by giving two injections 28 days apart to healthy adults. Participants will either receive the actual PIZV vaccine or a placebo and will be monitored closely for side effects and immune response over six months.See study design
What are the potential side effects?
While specific side effects are not listed here as it's a candidate vaccine under investigation, typical vaccine-related side effects may include pain at injection site, fever, fatigue, headache and muscle pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 28 days up to 6 months post dose 2 (up to day 211)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 28 days up to 6 months post dose 2 (up to day 211)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antibodies, Blocking
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
+9 moreSecondary outcome measures
GMTs for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants
Antibodies, Blocking
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PIZV 0.5 mLExperimental Treatment1 Intervention
Participants will receive PIZV 0.5 mL injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
Group II: Placebo 0.5 mLPlacebo Group1 Intervention
Participants will receive a placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
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Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,016 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,209 Previous Clinical Trials
489,464 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a healthy person.I have no history of severe neurological disorders like seizures or Guillain-Barré syndrome.I can follow the trial's procedures and be available for all follow-ups.I have had or currently have dengue, yellow fever, Japanese encephalitis, tick-borne encephalitis, or West Nile virus.I have a condition or take medications that affect my immune system.You are a female of childbearing potential.I can follow the trial's procedures and be available for all follow-ups.
Research Study Groups:
This trial has the following groups:- Group 1: PIZV 0.5 mL
- Group 2: Placebo 0.5 mL
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05469802 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the official position of PIZV from the FDA?
"While there is no data yet to support efficacy, PIZV receive a score of 2 because Phase 2 trials offer some evidence that it is safe."
Answered by AI
Are there any medical prerequisites to enrolling in this research program?
"The prerequisites for volunteers of this clinical trial are that they be in good health and between 18-64 years old. A total of 156 people are needed for the study."
Answered by AI
Are new patients being accepted into the trial at this time?
"Information available on clinicaltrials.gov reveals that this study is not enrolling patients at the moment. The trial was initially posted on December 5th, 2020 and was last updated on October 18th, 2020. There are 898 other trials which are currently looking for participants."
Answered by AI
If a patient is under 45, can they still participate in this research?
"The age range for this particular clinical trial is 18 to 64. In contrast, there are 53 different trials specifically for minors and 398 studies focused on senior citizens."
Answered by AI
Who else is applying?
What state do they live in?
Other
Florida
Ohio
Kansas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Velocity Clinical Research, Boise
Alliance for Multispecialty Research, LLC
CenExel Research Centers of America
Why did patients apply to this trial?
I really want to join this trial. I’ve been in other trials before. Looking for paid studies in my area.
PatientReceived no prior treatments
I want to help future in finding new vaccines to improve future health.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When can I start? Address? Time investment? Compensation?
PatientReceived no prior treatments
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