A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects.
Public ClinicalTrials.gov record NCT02963909. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, First-in-Human, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Healthy Flavivirus-Naïve and Flavivirus-Primed Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Phase 1 study to evaluate two doses of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) administered 28 days apart. The study will enroll 75 flavivirus naïve healthy adult subjects into 3 equal groups sequentially. Each group will include 20 ZPIV recipients and 5 placebo recipients. Group 1 will receive two ZPIV or placebo doses 28 days apart. Those in Group 1 who consent to a third ZPIV dose will receive 5.0 mcg dose of ZPIV or placebo administered IM on Day 224. Group 2 subjects will receive a two-dose regimen of IXIARO® 28 days apart; two ZPIV or placebo doses three months later 28 days apart. Those in Group 2 who consent to a third ZPIV dose will receive it on Day 336. Group 3 subjects will receive one dose of YF-VAX® followed three months later by two ZPIV or placebo doses 28 days apart. Those in Group 3 who consent to a third ZPIV dose will receive it on Day 308. In each group, those who do not agree to receive the third ZPIV dose will be followed based on the schedule. The primary objectives are: 1) To evaluate the safety and reactogenicity of a two-dose homologous prime boost regimen of ZPIV among flavivirus-naïve, YF-VAX® primed, and IXIARO® primed subjects; 2) To evaluate the safety and reactogenicity of a third dose of ZPIV in consenting subjects.
Study identification
- NCT ID
- NCT02963909
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Interventions
- IXIARO Biological
- Placebo Other
- YF Vax 17D Strain Biological
- Zika Virus Purified Inactivated Vaccine (ZPIV) Biological
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- Oct 29, 2018
- Completion
- Oct 29, 2018
- Last update posted
- Apr 21, 2024
2016 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Walter Reed Army Institute of Research - Clinical Trials Center | Silver Spring | Maryland | 20910-7500 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02963909, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02963909 live on ClinicalTrials.gov.