Purified Inactivated Zika Virus Vaccine (PIZV) for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Velocity Clinical Research, Boise, Meridian, ID
Healthy Subjects (HS)+1 More
Purified Inactivated Zika Virus Vaccine (PIZV) - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

12 Primary · 19 Secondary · Reporting Duration: Within 28 days post Booster Dose (Day 239) and 6 months post Booster Dose (Day 393)

Month 6
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From 28 Days up to 6 Months Post Dose 2
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From 28 Days up to 6 Months Post Dose 2
Percentage of Participants With at Least One Serious Adverse Event (SAE) From 28 Days up to 6 Months Post Dose 2
Day 393
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) Throughout the Entire Study Period
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) Throughout the Entire Study Period
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Entire Study Period
Day 393
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From Booster Administration Until End of Study
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From Booster Administration Until End of Study Period
Percentage of Participants With at Least One Serious Adverse Event (SAE) From Booster Administration Until End of Study Period
Day 57
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2
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
Month 6
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus
Day 29
Percentage of Participants With at Least One Unsolicited AE for 28 Days After First Dose of Vaccination
Day 29
Percentage of Participants With at Least One Unsolicited AE for 28 Days After Second Dose of Vaccination
Day 239
Percentage of Participants With Unsolicited AE During the 28-day Period Post Booster
Month 6
Percentage of Participants Who Received the Booster Dose With Seropositivity for Neutralizing Antibodies Against Zika Virus
Month 6
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus
Percentage of Participants Who Received the Booster Dose With Seroconversion for Neutralizing Antibodies Against Zika Virus
Day 217
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity During the 6-day Period Post Booster
Day 29
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After Second Dose of Vaccination
Percentage of Participants With Solicited Systemic AEs for 7 Days After Second Dose of Vaccination
Day 8
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After First Dose of Vaccination
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination After First Dose of Vaccination
Day 204
Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against Zika Virus Compared to Pre-Booster Dose
Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against Zika Virus Compared to Pre-Booster Dose in Participants Who Received a Booster Dose
Day 218
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus in Participants Who Received the Booster Dose
Percentage of Participants With Solicited Local Injection Site Reactions by Severity During the 7-day Period Post Booster
Percentage of Subset of Participants Who Received the Booster Dose With Seroconversion for Neutralizing Antibodies Against Zika Virus
Percentage of Subset of Participants Who Received the Booster Dose With Seropositivity for Neutralizing Antibodies Against Zika Virus

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Healthy Subjects (HS)

Trial Design

8 Treatment Groups

Booster Period: Group A (≥18 to <50 years): PIZV 0.5 ml
1 of 8
2-Dose Vaccination Period: Group A (≥18 to <50 years): PIZV 0.5 ml
1 of 8
2-Dose Vaccination Period: Group B (≥50 to <65 years): PIZV 0.5 ml
1 of 8
Booster Period: Group B (≥50 to <65 years): PIZV 0.5 ml
1 of 8
2-Dose Vaccination Period: Group A (≥18 to <50 years): Placebo
1 of 8
2-Dose Vaccination Period: Group B (≥50 to <65 years): Placebo
1 of 8
Booster Period: Group B (≥50 to <65 years): Placebo
1 of 8
Booster Period: Group A (≥18 to <50 years): Placebo
1 of 8
Experimental Treatment
Non-Treatment Group

156 Total Participants · 8 Treatment Groups

Primary Treatment: Purified Inactivated Zika Virus Vaccine (PIZV) · Has Placebo Group · Phase 2

Booster Period: Group A (≥18 to <50 years): PIZV 0.5 ml
Biological
Experimental Group · 1 Intervention: Purified Inactivated Zika Virus Vaccine (PIZV) · Intervention Types: Biological
2-Dose Vaccination Period: Group A (≥18 to <50 years): PIZV 0.5 ml
Biological
Experimental Group · 1 Intervention: Purified Inactivated Zika Virus Vaccine (PIZV) · Intervention Types: Biological
2-Dose Vaccination Period: Group B (≥50 to <65 years): PIZV 0.5 ml
Biological
Experimental Group · 1 Intervention: Purified Inactivated Zika Virus Vaccine (PIZV) · Intervention Types: Biological
Booster Period: Group B (≥50 to <65 years): PIZV 0.5 ml
Biological
Experimental Group · 1 Intervention: Purified Inactivated Zika Virus Vaccine (PIZV) · Intervention Types: Biological
2-Dose Vaccination Period: Group A (≥18 to <50 years): Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
2-Dose Vaccination Period: Group B (≥50 to <65 years): Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Booster Period: Group B (≥50 to <65 years): Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Booster Period: Group A (≥18 to <50 years): Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 28 days post booster dose (day 239) and 6 months post booster dose (day 393)
Closest Location: Velocity Clinical Research, Boise · Meridian, ID
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Who is running the clinical trial?

TakedaLead Sponsor
1,097 Previous Clinical Trials
4,059,264 Total Patients Enrolled
103 Trials studying Healthy Subjects (HS)
33,023 Patients Enrolled for Healthy Subjects (HS)
Study DirectorStudy DirectorTakeda
1,037 Previous Clinical Trials
478,398 Total Patients Enrolled
75 Trials studying Healthy Subjects (HS)
8,408 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are healthy.
You are a female of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.