A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the
      Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.
    

Detailed description: 
      1. Step 1

           Primary objective

             -  Investigate the optimum volume of GC1109 to compare the subject ratio after
                seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3
                times with the immunogenicity of each treatment (GC1109 and placebo cohort) in
                healthy adults.

             -  In healthy adults, three times the clinical dose of about four weeks, compare
                immunogenicity of each treatment group (GC1109 group and the placebo group) with
                subsects ratio who have been Seroconversion for Anti-PA Ab by TNA

           Secondary objective

             -  Percentage of subjects after seroconversion in each anti-PA IgG level (by ELISA) at
                4 weeks following infuse the drug 3 times in healthy adults

             -  Check the Seroprotection antibody titer (survival rate : 50%) with passive immune
                (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults

             -  Establish the Seroconversion rate from the percentage of subjects after
                seroconversion at 4 weeks following infuse the drug 3 times and seroprotection
                antibody titer in healthy adults

             -  Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA
                Ab by TNA for 4 weeks following infuse the drug 3 times

             -  Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA
                IgG by ELISA for 4 weeks following infuse the drug 3 times

             -  Determine the safety of the each treatment cohort

        2. Step 2

      Primary objective

      • Evaluate whether the Toxin Neutralization Antibody by TNA assay satisfy the NF50 standard
      or not at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults.

      Secondary objective

        -  Establish the safety of the GC1109 in healthy adults

        -  Establish the GMT of Toxin Neutralization Antibody by TNA assay after infusing the drug
           4 times until 24 weeks in healthy adults

        -  Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 4 times until 24 weeks
           in healthy adults
    

Intervention name(s): GC1109 or Placebo of GC1109
Intervention type(s): Biological
Intervention description(s): Step1: Administer 0.3mL or 0.5mL or 0.1mL or placebo of GC1109 into the deltoid muscle three times every four weeks.
Step2: Administer 1.0mL of GC1109 or placebo of GC1109 into the deltoid muscle three times every four weeks, and once after 24 weeks.
Other intervention name(s): rPA or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Step 1 (Number of Arms: 4), Step 2 (Number of Arms: 2)
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Anthrax vaccine