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Efficacy and Safety of Anthrax Vaccine, GC1109

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867957
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : June 5, 2013
Sponsor:
Collaborators:
Green Cross Corporation
LSK Global Pharma Services Co. Ltd.
Information provided by (Responsible Party):
Myoung-don Oh, 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

Condition or disease Intervention/treatment Phase
Anthrax Biological: Low-dose GC1109 Biological: High-dose GC1109 Biological: Low-dose Placebo Biological: High-dose Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : February 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax

Arm Intervention/treatment
Experimental: Low-dose GC1109 Biological: Low-dose GC1109
50ug/dose
Other Name: GC1109 50ug/dose (0.5 ml) vaccination

Placebo Comparator: Low-dose Placebo Biological: Low-dose Placebo
0.9% Saline 0.5 mL
Other Name: 0.9% Saline 0.5 mL vaccination

Experimental: High-dose GC1109 Biological: High-dose GC1109
100ug/dose
Other Name: GC1109 100ug/dose (1.0 ml) vaccination

Placebo Comparator: High-dose Placebo Biological: High-dose Placebo
0.9% Saline 1.0 mL
Other Name: 0.9% Saline 1.0 mL vaccination




Primary Outcome Measures :
  1. Adverse Event [ Time Frame: 0 - 28 Days ]

Secondary Outcome Measures :
  1. Anti-protective antigen(PA) antibody level (by TNA) [ Time Frame: Day 14, Day 28 ]
  2. Anti-PA Immunoglobulin G (IgG) (by ELISA) [ Time Frame: Day 14, Day 28 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867957


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Green Cross Corporation
LSK Global Pharma Services Co. Ltd.
Investigators
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Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital

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Responsible Party: Myoung-don Oh, Professor, Division of Infectious Diseases, Department of Internal Medicine, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01867957     History of Changes
Other Study ID Numbers: GC1109_P1_v1.2
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Myoung-don Oh, Seoul National University Hospital:
anthrax
vaccine
bioterrorism
efficacy
safety
Additional relevant MeSH terms:
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Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs