Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
Public ClinicalTrials.gov record NCT03343626. 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, Randomized, Observer-Blind, Placebo-Controlled, Safety, Immunogenicity, and Dose Ranging Study of Purified Inactivated Zika Virus Vaccine (PIZV) Candidate in Flavivirus Naïve and Primed Healthy Adults Aged 18 to 49 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram \[mcg\]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.
Study identification
- NCT ID
- NCT03343626
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 271 participants
Conditions and interventions
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
- Nov 13, 2017 (Actual)
- Primary completion
- Dec 28, 2018 (Actual)
- Completion
- Nov 24, 2020 (Actual)
- Last update posted
- Feb 11, 2022
2017 – 2020
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Miami Research Associates | Miami | Florida | 33143 | — |
| AppleMed Research | Miami | Florida | 33155 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Regional Clinical Research Inc. | Endwell | New York | 13760 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Tekton Research | Austin | Texas | 78745 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03343626, 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 Feb 11, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03343626 live on ClinicalTrials.gov.