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NCT01381744 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Trial of a Plague Vaccine, Flagellin/F1/V, in Healthy Adult Volunteers

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

Completed
Registry status
Phase 1
Development phase
48
Enrollment target

NCT01381744: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01381744 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01381744, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study Summary

Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis. Modern antibiotics are effective against plague, but if an infected person is not treated promptly the disease is likely to cause illness or death. The purpose of this study is to evaluate at the safety, immunogenicity (bodily defense reaction), and tolerability of a new research vaccine. Up to 48 people will be enrolled in this study at the Center for Vaccine Development at Saint Louis University. Four groups of 12 volunteers will be given vaccine or placebo (inactive substance) one group at a time starting with the lowest dose working up to the highest dose. Shots will be given in the arm 2 times separated by 28 days. Study procedures include: physical exam, blood samples, and recording temperature and side effects in a memory aid. Participants will be involved in study related procedures for about 13 months.

Interventions

  • OTHER Placebo
  • BIOLOGICAL Flagellin/F1/V

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2012-02
Est. Completion 2014-08
Phase Phase 1

What the finished NCT01381744 record still lists

NCT01381744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01381744 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01381744 about?

NCT01381744 is a clinical study titled "Dose Escalation Trial of a Plague Vaccine, Flagellin/F1/V, in Healthy Adult Volunteers". Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis. Modern antibiotics are effective against plague, but if an infected person is not treated promptly the disease is likely to cause illness or death. The purpose of this study is to evaluate at the safety, immun...

What is the current status of trial NCT01381744?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-02. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01381744?

The interventions under investigation include: Placebo (OTHER), Flagellin/F1/V (BIOLOGICAL).

Who is sponsoring clinical trial NCT01381744?

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

How this trial's enrollment target compares

Where NCT01381744's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01381744, the US trial registry maintained by the National Library of Medicine. NCT01381744 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.