Efficacy and Safety of Anthrax Vaccine, GC1109

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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