Efficacy and Safety of Anthrax Vaccine, GC1109

Phase 1

Completed

• Conditions: Anthrax
• Interventions: Biological: Low-dose GC1109; Biological: Low-dose Placebo; Biological: High-dose GC1109; Biological: High-dose Placebo

• Registration Number: NCT01867957
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Study First Posted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose GC1109	Low-dose GC1109	-
Low-dose Placebo	Low-dose Placebo	-
High-dose GC1109	High-dose GC1109	-
High-dose Placebo	High-dose Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse Event	0 - 28 Days

Secondary Outcome Measures

Name	Time	Method
Anti-protective antigen(PA) antibody level (by TNA)	Day 14, Day 28
Anti-PA Immunoglobulin G (IgG) (by ELISA)	Day 14, Day 28

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of