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OpenTrials
Completed

NCT Number: NCT01867957

Efficacy and Safety of Anthrax Vaccine, GC1109

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

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Key information

Conditions

Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Low-dose GC1109

Biological

50ug/dose

Other names: GC1109 50ug/dose (0.5 ml) vaccination

High-dose GC1109

Biological

100ug/dose

Other names: GC1109 100ug/dose (1.0 ml) vaccination

Low-dose Placebo

Biological

0.9% Saline 0.5 mL

Other names: 0.9% Saline 0.5 mL vaccination

High-dose Placebo

Biological

0.9% Saline 1.0 mL

Other names: 0.9% Saline 1.0 mL vaccination

Primary outcomes

  1. Adverse Event

    Time frame: 0 - 28 Days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Green Cross Corporation
  • LSK Global Pharma Services Co. Ltd.

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2013
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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