Efficacy and Safety of Anthrax Vaccine, GC1109

Anthrax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867957
• Other study ID #: GC1109_P1_v1.2
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2013
• Last updated: June 3, 2013
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anthrax

Intervention

Biological:
• Low-dose GC1109
50ug/dose
• High-dose GC1109
100ug/dose
• Low-dose Placebo
0.9% Saline 0.5 mL
• High-dose Placebo
0.9% Saline 1.0 mL

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Green Cross Corporation, LSK Global Pharma Services Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event		0 - 28 Days	Yes
Secondary	Anti-protective antigen(PA) antibody level (by TNA)		Day 14, Day 28	No
Secondary	Anti-PA Immunoglobulin G (IgG) (by ELISA)		Day 14, Day 28	No