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NCT00097396 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
A Phase 1 study of Pneumonic Plague and Preventive Therapy, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00097396: Completed Phase 1 study of Pneumonic Plague and Preventive Therapy, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
NCT00097396 is a Phase 1 study of Pneumonic Plague and Preventive Therapy that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097396, a Phase 1 study of Pneumonic Plague and Preventive Therapy, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
Conditions Studied
Interventions
- BIOLOGICAL rF1V vaccine
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
What the finished NCT00097396 record still lists
NCT00097396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Pneumonic Plague appearing as the primary indexed condition, and to 1 intervention - of which rF1V vaccine is the first listed.
NCT00097396 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT00097396 about?
NCT00097396 is a clinical study titled "Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V". The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and to...
What is the current status of trial NCT00097396?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-11. Estimated completion is 2006-09.
What conditions does trial NCT00097396 study?
This clinical trial studies the following conditions: Pneumonic Plague, Preventive Therapy.
What interventions are being tested in trial NCT00097396?
The interventions under investigation include: rF1V vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00097396?
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 NCT00097396 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00097396's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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