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NCT01110551 · ClinicalTrials.gov registry record · Phase 1

Tetravalent Chimeric Dengue Vaccine Trial

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

Completed
Registry status
Phase 1
Development phase
72
Enrollment target
1
Study location

NCT01110551 is a Phase 1 study of Dengue that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 72 participants, below the 3,973-participant average among 9 other Dengue trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01110551, a Phase 1 study of Dengue, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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

Study Summary

The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.

Conditions Studied

Dengue

Interventions

  • DRUG Placebo (SC)
  • DRUG Placebo (ID)
  • BIOLOGICAL Modified Live Tetravalent Chimeric Dengue Vaccine (SC)
  • BIOLOGICAL Modified Live Tetravalent Chimeric Dengue Vaccine (ID)

Study Locations (1)

Missouri

  • Saint Louis University - Center for Vaccine Development - St Louis

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2010-05
Est. Completion 2012-12
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 NCT01110551

The ClinicalTrials.gov registry entry for NCT01110551 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,973-participant average among 9 other Dengue 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 1 condition, with Dengue appearing as the primary indexed condition, and to 4 interventions - of which Placebo (SC) is the first listed.

NCT01110551 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT01110551 about?

NCT01110551 is a clinical study titled "Tetravalent Chimeric Dengue Vaccine Trial". The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to...

What is the current status of trial NCT01110551?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2010-05. Estimated completion is 2012-12.

What conditions does trial NCT01110551 study?

This clinical trial studies the following conditions: Dengue.

What interventions are being tested in trial NCT01110551?

The interventions under investigation include: Placebo (SC) (DRUG), Placebo (ID) (DRUG), Modified Live Tetravalent Chimeric Dengue Vaccine (SC) (BIOLOGICAL), Modified Live Tetravalent Chimeric Dengue Vaccine (ID) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01110551?

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 NCT01110551 being conducted?

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

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

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.