Efficacy and Safety of Anthrax Vaccine, GC1109

June 3, 2013 updated by: Myoung-don Oh, Seoul National University Hospital

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

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose GC1109
Biological: Low-dose GC1109
50ug/dose
Other Names:
  • GC1109 50ug/dose (0.5 ml) vaccination
Placebo Comparator: Low-dose Placebo
Biological: Low-dose Placebo
0.9% Saline 0.5 mL
Other Names:
  • 0.9% Saline 0.5 mL vaccination
Experimental: High-dose GC1109
Biological: High-dose GC1109
100ug/dose
Other Names:
  • GC1109 100ug/dose (1.0 ml) vaccination
Placebo Comparator: High-dose Placebo
Biological: High-dose Placebo
0.9% Saline 1.0 mL
Other Names:
  • 0.9% Saline 1.0 mL vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event
Time Frame: 0 - 28 Days
0 - 28 Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Green Cross Corporation
LSK Global Pharma Services Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC1109_P1_v1.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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