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Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults

Primary Purpose

Tuberculosis

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC3107
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults aged 19-64 years old
  • Informed consent form has been signed and dated
  • Able to comply with the requirements of the study
  • Female subjects who have negative results in Urine hCG test at screening, or menopausal women.

Exclusion Criteria:

  • Subjects who have positive results(;induration diameter over 5mm) in Tuberculin Skin Test(TST) at screening
  • Subjects who shown abnormal results(including inactive tuberculosis) on Chest X-ray at screening
  • Subjects who received a vaccination(including live vaccine) within 28 days before enrollment
  • Subjects who are on antituberculosis drugs
  • Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
  • Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
  • Pregant or lactating women

Sites / Locations

  • Korea University Guro HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GC3107

Arm Description

BCG Vaccine, 0.1mL

Outcomes

Primary Outcome Measures

Adverse Event
Solicited/Unsolicited Adverse Event

Secondary Outcome Measures

Whether the maximum Induration diameter greater than 5mm after TST.
Induration diameter measured in the direction perpendicular to the arm.
Whether the maximum Erythema/Redness diameter greater than 5mm after TST.
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Maximum diameter of Induration after TST.
Induration diameter measured in the direction perpendicular to the arm.
Maximum diameter of Erythema/Redness after TST.
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Maximum diameter variation of Induration after TST.
Induration diameter measured in the direction perpendicular to the arm.
Maximum diameter variation of Erythema/Redness after TST.
Erythema/Redness diameter measured in the direction perpendicular to the arm.

Full Information

First Posted
November 30, 2017
Last Updated
December 15, 2017
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03363178
Brief Title
Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
Official Title
A Single-arm, Open-label, Single-center, Phase 1 Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) After Intradermal Administration in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.
Detailed Description
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Tuberculin Skin Test(TST) will be conducted after 84+7 days after IP injection and TST result will be read in 48~72 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GC3107
Arm Type
Experimental
Arm Description
BCG Vaccine, 0.1mL
Intervention Type
Biological
Intervention Name(s)
GC3107
Intervention Description
BCG Vaccine, 0.1mL
Primary Outcome Measure Information:
Title
Adverse Event
Description
Solicited/Unsolicited Adverse Event
Time Frame
for 7 days from Day0/during study period
Secondary Outcome Measure Information:
Title
Whether the maximum Induration diameter greater than 5mm after TST.
Description
Induration diameter measured in the direction perpendicular to the arm.
Time Frame
Day0+84days
Title
Whether the maximum Erythema/Redness diameter greater than 5mm after TST.
Description
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Time Frame
Day0+84days
Title
Maximum diameter of Induration after TST.
Description
Induration diameter measured in the direction perpendicular to the arm.
Time Frame
Day0+84days
Title
Maximum diameter of Erythema/Redness after TST.
Description
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Time Frame
Day0+84days
Title
Maximum diameter variation of Induration after TST.
Description
Induration diameter measured in the direction perpendicular to the arm.
Time Frame
Day0+84days
Title
Maximum diameter variation of Erythema/Redness after TST.
Description
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Time Frame
Day0+84days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 19-64 years old Informed consent form has been signed and dated Able to comply with the requirements of the study Female subjects who have negative results in Urine hCG test at screening, or menopausal women. Exclusion Criteria: Subjects who have positive results(;induration diameter over 5mm) in Tuberculin Skin Test(TST) at screening Subjects who shown abnormal results(including inactive tuberculosis) on Chest X-ray at screening Subjects who received a vaccination(including live vaccine) within 28 days before enrollment Subjects who are on antituberculosis drugs Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy Subjects with severe chronic disease who are considered by investigator to be ineligible for the study Pregant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoonjung Nam, Pharm.D
Phone
+81-260-9143
Email
clairenam@greencross.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Joo Kim, M.D, Ph.D
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Joo Kim, M.D. Ph.D.
Email
wjkim@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
Woo Joo Kim, M.D. Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults

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