NCT01867957

Brief Summary

  • single-blinded
  • randomized
  • placebo controlled
  • phase 1 study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

May 30, 2013

Last Update Submit

June 3, 2013

Conditions

Anthrax

Keywords

anthraxvaccinebioterrorismefficacysafety

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    0 - 28 Days

Secondary Outcomes (2)

  • Anti-protective antigen(PA) antibody level (by TNA)

    Day 14, Day 28

  • Anti-PA Immunoglobulin G (IgG) (by ELISA)

    Day 14, Day 28

Study Arms (4)

Low-dose GC1109

EXPERIMENTAL
Biological: Low-dose GC1109

Low-dose Placebo

PLACEBO COMPARATOR
Biological: Low-dose Placebo

High-dose GC1109

EXPERIMENTAL
Biological: High-dose GC1109

High-dose Placebo

PLACEBO COMPARATOR
Biological: High-dose Placebo

Interventions

Low-dose GC1109BIOLOGICAL

50ug/dose

Also known as: GC1109 50ug/dose (0.5 ml) vaccination
Low-dose GC1109
High-dose GC1109BIOLOGICAL

100ug/dose

Also known as: GC1109 100ug/dose (1.0 ml) vaccination
High-dose GC1109
Low-dose PlaceboBIOLOGICAL

0.9% Saline 0.5 mL

Also known as: 0.9% Saline 0.5 mL vaccination
Low-dose Placebo
High-dose PlaceboBIOLOGICAL

0.9% Saline 1.0 mL

Also known as: 0.9% Saline 1.0 mL vaccination
High-dose Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects between 18 and 45 years of age at the time of screening visit
  • kg/m2 ≤BMI \< 30kg/m2 at the time of screening visit
  • Subjects without congenital or chronic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Anthrax

Interventions

VaccinationSodium Chloride

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public HealthChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Myoung-don Oh, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Division of Infectious Diseases, Department of Internal Medicine

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 4, 2013

Study Start

February 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

KR(1)