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NCT00106769 · ClinicalTrials.gov registry record · Phase 1

Vaccine to Prevent West Nile Virus Disease

A Phase 1 study of Healthy and Healthy Volunteer, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT00106769 is a Phase 1 study of Healthy and Healthy Volunteer that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00106769, a Phase 1 study of Healthy and Healthy Volunteer, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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

Study Summary

This study will test the safety of an experimental vaccine intended to prevent West Nile virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in death. The vaccine used in this study contains DNA that instructs the body to produce a small amount of a protein found in WNV. If the body creates resistance or immunity to these proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from the vaccine. Healthy volunteers between 18 years and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a pregnancy test for women who can become pregnant. Patients undergo the following tests and procedures: * Vaccine injections: Vaccines are given as injections in the upper arm, using a needleless system called the Biojector 2000. The first injection is on study day 0, the second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at least 21 days between injections. The pregnancy test for women of childbearing potential is repeated the day of each vaccine injection. * Diary card: Participants are given a 5-day diary card after each injection to record their temperature and any symptoms and side effects they may experience for up to 5 days after the injection. The diary cards are returned to the clinic at visits scheduled 2 weeks after each injection. Side effects and symptoms also must be reported immediately to a study nurse or doctor, and a clinic visit may be required for an examination. * Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a medical history, physical examination (if needed) and blood tests. Vital signs and weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and 12, and urine samples are collected at day 0 and weeks 2, 4, 6,

Conditions Studied

Healthy Healthy Volunteer West Nile Fever HV

Interventions

  • DRUG VRC-WNVDNA017-00-VP

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2005-03-22
Est. Completion 2008-01-15
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00106769

The ClinicalTrials.gov registry entry for NCT00106769 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). 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 4 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which VRC-WNVDNA017-00-VP is the first listed.

NCT00106769 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00106769 about?

NCT00106769 is a clinical study titled "Vaccine to Prevent West Nile Virus Disease". This study will test the safety of an experimental vaccine intended to prevent West Nile virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in death. The vaccine used in this ...

What is the current status of trial NCT00106769?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2005-03-22. Estimated completion is 2008-01-15.

What conditions does trial NCT00106769 study?

This clinical trial studies the following conditions: Healthy, Healthy Volunteer, West Nile Fever, HV.

What interventions are being tested in trial NCT00106769?

The interventions under investigation include: VRC-WNVDNA017-00-VP (DRUG).

Who is sponsoring clinical trial NCT00106769?

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 NCT00106769 being conducted?

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

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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.