Clinical Trial: Efficacy and Safety of Anthrax Vaccine, GC1109

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

Official Title: A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men

Brief Summary:

  1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.

  2. OBJECTIVE

    - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.

  3. STUDY DESIGN

    • single-blinded
    • randomized
    • placebo controlled
    • phase 1 study

Detailed Summary:
Sponsor: Seoul National University Hospital

Current Primary Outcome: Adverse Event [ Time Frame: 0 - 28 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anti-protective antigen(PA) antibody level (by TNA) [ Time Frame: Day 14, Day 28 ]
  • Anti-PA Immunoglobulin G (IgG) (by ELISA) [ Time Frame: Day 14, Day 28 ]


Original Secondary Outcome:

  • Anti-PA antibody level (by TNA) [ Time Frame: Day 14, Day 28 ]
  • Anti-PA IgG (by ELISA) [ Time Frame: Day 14, Day 28 ]


Information By: Seoul National University Hospital

Dates:
Date Received: May 30, 2013
Date Started: February 2009
Date Completion:
Last Updated: June 3, 2013
Last Verified: June 2013