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COMPLETED Phase 1

Tetravalent Chimeric Dengue Vaccine Trial

NCT01110551 · View on ClinicalTrials.gov ↗

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

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01110551

The ClinicalTrials.gov registry entry for NCT01110551 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 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 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01110551 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01110551?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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