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A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

NCT00057525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2011-06-30

No results posted yet for this study

Summary

This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.

Conditions

  • Anthrax

Interventions

BIOLOGICAL

Anthrax

Doses will range from 5 \_g to 100 \_g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel

BIOLOGICAL

Alhdryogel or PBS

Doses will range from 5 \_g to 100 \_g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel

Sponsors & Collaborators

  • DynPort Vaccine Company LLC, A GDIT Company

    lead INDUSTRY

Principal Investigators

  • Merlin L Robb, MD · Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr., Rockville, MD 20850

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-04-30
Completion
2004-08-31

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 NCT00057525 on ClinicalTrials.gov