Trial | NCT01867957  Report issue

Title

Efficacy and Safety of Anthrax Vaccine, GC1109
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gc1109 ...

  • Study Participants

    20
BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.

OBJECTIVE

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

STUDY DESIGN

single-blinded
randomized
placebo controlled
phase 1 study
Study Started
Feb 28
2009
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Jun 05
2013
Estimate

Biological Low-dose GC1109

50ug/dose

  • Other names: GC1109 50ug/dose (0.5 ml) vaccination

Biological High-dose GC1109

100ug/dose

  • Other names: GC1109 100ug/dose (1.0 ml) vaccination

Biological Low-dose Placebo

0.9% Saline 0.5 mL

  • Other names: 0.9% Saline 0.5 mL vaccination

Biological High-dose Placebo

0.9% Saline 1.0 mL

  • Other names: 0.9% Saline 1.0 mL vaccination

Low-dose GC1109 Experimental

Low-dose Placebo Placebo Comparator

High-dose GC1109 Experimental

High-dose Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

Healthy male subjects between 18 and 45 years of age at the time of screening visit
18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
Subjects without congenital or chronic disorder

Exclusion Criteria:

-
No Results Posted