Efficacy and Safety of Anthrax Vaccine, GC1109

Seoul National University Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Anthrax

Interventions

Low-dose GC1109BIOLOGICAL

50ug/dose

High-dose GC1109BIOLOGICAL

100ug/dose

Low-dose PlaceboBIOLOGICAL

0.9% Saline 0.5 mL

High-dose Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse Event

Time frame: 0 - 28 Days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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