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Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults

NCT00098098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-08-23

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.

Conditions

  • RECOMBINANT BOTULINUM VACCINE A/B

Interventions

BIOLOGICAL

rBV A/B

Sponsors & Collaborators

  • DynPort Vaccine Company LLC, A GDIT Company

    lead INDUSTRY

Principal Investigators

  • Richard Greenberg, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-08-31
Completion
2005-08-31

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 NCT00098098 on ClinicalTrials.gov