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Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V

NCT00097396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-06-30

No results posted yet for this 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

  • Pneumonic Plague
  • Preventive Therapy

Interventions

BIOLOGICAL

rF1V vaccine

Sponsors & Collaborators

  • DynPort Vaccine Company LLC, A GDIT Company

    lead INDUSTRY

Principal Investigators

  • Richard N Greenberg, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2006-07-31
Completion
2006-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00097396 on ClinicalTrials.gov