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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Study of Safety and Immunogenicity of E. Coli-Derived Recombinant Protective Antigen (rPA), a New Anthrax Vaccine Administered by the Intramuscular (IM) Route in

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 Summary: 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
Sponsor: DynPort Vaccine Company LLC, A CSC Company

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: DynPort Vaccine Company LLC, A CSC Company

Dates:
Date Received: April 3, 2003
Date Started: April 2003
Date Completion:
Last Updated: June 29, 2011
Last Verified: June 2011