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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01867957

Enrollment

Registered

2013-06-04

Start date

2009-02-28

Completion date

2009-12-31

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anthrax

Keywords

anthrax, vaccine, bioterrorism, efficacy, safety

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

Interventions

BIOLOGICALLow-dose GC1109

50ug/dose

BIOLOGICALHigh-dose GC1109

100ug/dose

BIOLOGICALLow-dose Placebo

0.9% Saline 0.5 mL

BIOLOGICALHigh-dose Placebo

0.9% Saline 1.0 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Adverse Event	0 - 28 Days

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026