Clinical Trial: PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine

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

Official Title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults

Brief Summary: The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel

Detailed Summary:
Sponsor: Fraunhofer, Center for Molecular Biotechnology

Current Primary Outcome: Number of Participants with Adverse Events [ Time Frame: Up to 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from Baseline in antibody titer after three immunizations [ Time Frame: Up to 6 months ]

Original Secondary Outcome: Same as current

Information By: Fraunhofer, Center for Molecular Biotechnology

Dates:
Date Received: August 13, 2014
Date Started: August 2014
Date Completion:
Last Updated: May 10, 2016
Last Verified: May 2016