Efficacy and Safety of Anthrax Vaccine, GC1109

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Anthrax

Treatments: Biological: High-dose GC1109; Biological: Low-dose Placebo; Biological: High-dose Placebo; Biological: Low-dose GC1109

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01867957

GC1109_P1_v1.2

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects between 18 and 45 years of age at the time of screening visit
2. 18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
3. Subjects without congenital or chronic disorder

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 4 patient groups, including a placebo group

Low-dose GC1109

Experimental group

Treatment:

Biological: Low-dose GC1109

Low-dose Placebo

Placebo Comparator group

Treatment:

Biological: Low-dose Placebo

High-dose GC1109

Experimental group

Treatment:

Biological: High-dose GC1109

High-dose Placebo

Placebo Comparator group

Treatment:

Biological: High-dose Placebo