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

Phase 1

Completed

• Conditions: Anthrax

• Registration Number: NCT00057525
• Lead Sponsor: DynPort Vaccine Company LLC, A GDIT Company

Brief 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.

Detailed Description

This is a safety study with an open-label part (2 groups), followed by a dose-ranging part evaluating safety and immunogenicity using a double-blind, sequential-group design with randomization and placebo-control within each of the 6 groups. Volunteers in each dose group will receive two IM injections at Day 0 and Month 1

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-04-03
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-07
• Primary Completion: 2004-04
• Study Completion: 2004-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr; 🇺🇸 Rockville, Maryland, United States