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NCT01122784 · ClinicalTrials.gov registry record · Phase 2

Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant

A Phase 2 study of Plague Vaccine, sponsored by DynPort Vaccine Company LLC, A GDIT Company.

Completed
Registry status
Phase 2
Development phase
402
Enrollment target
11
Study locations

NCT01122784: Completed Phase 2 study of Plague Vaccine, sponsored by DynPort Vaccine Company LLC, A GDIT Company.

NCT01122784 is a Phase 2 study of Plague Vaccine that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 402 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01122784, a Phase 2 study of Plague Vaccine, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.

COMPLETED
Registry status
Phase 2
Development phase
402 participants
Enrollment target
11
Study locations

Study Summary

Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).

Conditions Studied

Interventions

  • BIOLOGICAL rF1V vaccine (with Adjuvant)
  • BIOLOGICAL rF1V vaccine (without Adjuvant)

Study Locations (11)

California

  • Benchmark Research - San Francisco
  • Apex Research Institute - Santa Ana

Kansas

  • Johnson County Clinical Trials - Lenexa
  • Heartland Reseach Assoicates, LLC - Wichita

Kentucky

  • Central Kentucky Research Associates - Lexington

Maryland

  • WRAIR Clinical Trials Center - Silver Spring

Missouri

  • Center for Pharmceutical Research - Kansas City

New York

  • Rochester Clinical Research - Rochester

North Carolina

  • Wake Research Associates - Raleigh

South Carolina

  • Coastal Carolina Research Center - Mt. Pleasant

Trial Details

FieldValue
Enrollment Target 402 participants
Start Date 2010-07
Est. Completion 2012-07
Phase Phase 2

What the finished NCT01122784 record still lists

NCT01122784 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher).

The record links to 1 condition, with Plague Vaccine appearing as the primary indexed condition, and to 2 interventions - of which rF1V vaccine (with Adjuvant) is the first listed.

NCT01122784 lists 11 locations in 9 states (California, Kansas, Kentucky).

Frequently Asked Questions

What is clinical trial NCT01122784 about?

NCT01122784 is a clinical study titled "Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant". Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vacci...

What is the current status of trial NCT01122784?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 402 participants. The study started on 2010-07. Estimated completion is 2012-07.

What conditions does trial NCT01122784 study?

This clinical trial studies the following conditions: Plague Vaccine.

What interventions are being tested in trial NCT01122784?

The interventions under investigation include: rF1V vaccine (with Adjuvant) (BIOLOGICAL), rF1V vaccine (without Adjuvant) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01122784?

This trial is sponsored by DynPort Vaccine Company LLC, A GDIT Company, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01122784 being conducted?

This trial has 11 study locations across California, Kansas, Kentucky, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01122784's enrollment target sits among peer trials

402 96th of 2000 higher than 1,905 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01122784, the US trial registry maintained by the National Library of Medicine. NCT01122784 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.