Back to resultsEfficacy and Safety of Anthrax Vaccine, GC1109
Primary Purpose
Anthrax
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low-dose GC1109
High-dose GC1109
Low-dose Placebo
High-dose Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Anthrax focused on measuring anthrax, vaccine, bioterrorism, efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects between 18 and 45 years of age at the time of screening visit
- 18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
- Subjects without congenital or chronic disorder
Exclusion Criteria:
-
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Low-dose GC1109
Low-dose Placebo
High-dose GC1109
High-dose Placebo
Arm Description
Outcomes
Primary Outcome Measures
Adverse Event
Secondary Outcome Measures
Anti-protective antigen(PA) antibody level (by TNA)
Anti-PA Immunoglobulin G (IgG) (by ELISA)
Full Information
NCT ID
NCT01867957
First Posted
May 30, 2013
Last Updated
June 3, 2013
Sponsor
Seoul National University Hospital
Collaborators
Green Cross Corporation, LSK Global Pharma Services Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01867957
Brief Title
Efficacy and Safety of Anthrax Vaccine, GC1109
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Green Cross Corporation, LSK Global Pharma Services Co. Ltd.
4. Oversight
5. Study Description
Brief Summary
BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
OBJECTIVE
- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
STUDY DESIGN
single-blinded
randomized
placebo controlled
phase 1 study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthrax
Keywords
anthrax, vaccine, bioterrorism, efficacy, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose GC1109
Arm Type
Experimental
Arm Title
Low-dose Placebo
Arm Type
Placebo Comparator
Arm Title
High-dose GC1109
Arm Type
Experimental
Arm Title
High-dose Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Low-dose GC1109
Other Intervention Name(s)
GC1109 50ug/dose (0.5 ml) vaccination
Intervention Description
50ug/dose
Intervention Type
Biological
Intervention Name(s)
High-dose GC1109
Other Intervention Name(s)
GC1109 100ug/dose (1.0 ml) vaccination
Intervention Description
100ug/dose
Intervention Type
Biological
Intervention Name(s)
Low-dose Placebo
Other Intervention Name(s)
0.9% Saline 0.5 mL vaccination
Intervention Description
0.9% Saline 0.5 mL
Intervention Type
Biological
Intervention Name(s)
High-dose Placebo
Other Intervention Name(s)
0.9% Saline 1.0 mL vaccination
Intervention Description
0.9% Saline 1.0 mL
Primary Outcome Measure Information:
Title
Adverse Event
Time Frame
0 - 28 Days
Secondary Outcome Measure Information:
Title
Anti-protective antigen(PA) antibody level (by TNA)
Time Frame
Day 14, Day 28
Title
Anti-PA Immunoglobulin G (IgG) (by ELISA)
Time Frame
Day 14, Day 28
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects between 18 and 45 years of age at the time of screening visit
18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
Subjects without congenital or chronic disorder
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myoung-don Oh, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Anthrax Vaccine, GC1109
We'll reach out to this number within 24 hrs