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NCT02952833 · ClinicalTrials.gov registry record · Phase 1

ZIKA Vaccine in Naive Subjects

A Phase 1 study of Zika Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
91
Enrollment target
1
Study location

NCT02952833 is a Phase 1 study of Zika Virus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 91 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT02952833, a Phase 1 study of Zika Virus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
91 participants
Enrollment target
1
Study location

Study Summary

This study is a study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The entire duration of each subject's participation is approximately 14 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and samples for the assessment of immunogenicity. This study is expected to take approximately 30 months to complete from initiation through availability of a final report on the primary outcomes of safety and the secondary outcomes of humoral immunity to ZIKV. The Primary objectives of this study are to 1. Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at three different dose levels and 2. Compare the safety and reactogenicity profile of ZPIV after each vaccination and between dosage groups.

Conditions Studied

Interventions

  • DRUG Saline
  • BIOLOGICAL Zika Virus Purified Inactivated Vaccine (ZPIV)

Study Locations (1)

Missouri

  • Saint Louis University Center for Vaccine Development - St Louis

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2016-10-14
Est. Completion 2018-12-05
Phase Phase 1

What the Registry Record Tells You About NCT02952833

The ClinicalTrials.gov registry entry for NCT02952833 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Zika Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT02952833 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT02952833 about?

NCT02952833 is a clinical study titled "ZIKA Vaccine in Naive Subjects". This study is a study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The entire duration of each subject's participation is approximately 14 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and samples for the assessment o...

What is the current status of trial NCT02952833?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2016-10-14. Estimated completion is 2018-12-05.

What conditions does trial NCT02952833 study?

This clinical trial studies the following conditions: Zika Virus Infection.

What interventions are being tested in trial NCT02952833?

The interventions under investigation include: Saline (DRUG), Zika Virus Purified Inactivated Vaccine (ZPIV) (BIOLOGICAL).

Who is sponsoring clinical trial NCT02952833?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02952833 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.