Efficacy and Safety of Anthrax Vaccine, GC1109 | NCT01867957

Studies
Efficacy and Safety of Anthrax Vaccine, GC1109

NCT01867957

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 5, 2013Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Anthrax

Interventions

Low-dose GC1109
High-dose GC1109
Low-dose Placebo
High-dose Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

May 30, 2013

First Submission Date that Met QC Criteria

May 30, 2013

First Posted Date

Jun 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2013

Last Update Posted Date

Jun 5, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Myoung-don Oh, Professor, Division of Infectious Diseases, Department of Internal Medicine, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Green Cross Corporation	INDUSTRY
LSK Global Pharma Services Co. Ltd.	UNKNOWN

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Low-dose GC1109	Biological	50ug/dose	Low-dose GC1109	GC1109 50ug/dose (0.5 ml) vaccination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Event		0 - 28 Days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myoung-don Oh, M.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000881	Anthrax

Ancestor Terms

ID	Term
D016863	Bacillaceae Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014611	Vaccination
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D016233	Immunotherapy, Active
D007114	Immunization
D007167	Immunotherapy
D056747	Immunomodulation

Browse Leaves

Not provided

Browse Branches

Not provided