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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363178
Recruitment Status : Unknown
Verified November 2017 by Green Cross Corporation.
Recruitment status was:  Recruiting
First Posted : December 6, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Tracking Information
First Submitted Date  ICMJE November 30, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date December 18, 2017
Actual Study Start Date  ICMJE December 14, 2017
Estimated Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
Adverse Event [ Time Frame: for 7 days from Day0/during study period ]
Solicited/Unsolicited Adverse Event
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • Whether the maximum Induration diameter greater than 5mm after TST. [ Time Frame: Day0+84days ]
    Induration diameter measured in the direction perpendicular to the arm.
  • Whether the maximum Erythema/Redness diameter greater than 5mm after TST. [ Time Frame: Day0+84days ]
    Erythema/Redness diameter measured in the direction perpendicular to the arm.
  • Maximum diameter of Induration after TST. [ Time Frame: Day0+84days ]
    Induration diameter measured in the direction perpendicular to the arm.
  • Maximum diameter of Erythema/Redness after TST. [ Time Frame: Day0+84days ]
    Erythema/Redness diameter measured in the direction perpendicular to the arm.
  • Maximum diameter variation of Induration after TST. [ Time Frame: Day0+84days ]
    Induration diameter measured in the direction perpendicular to the arm.
  • Maximum diameter variation of Erythema/Redness after TST. [ Time Frame: Day0+84days ]
    Erythema/Redness diameter measured in the direction perpendicular to the arm.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tuberculosis
Intervention  ICMJE Biological: GC3107
BCG Vaccine, 0.1mL
Study Arms  ICMJE Experimental: GC3107
BCG Vaccine, 0.1mL
Intervention: Biological: GC3107
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 30, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2018
Estimated Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363178
Other Study ID Numbers  ICMJE GC3107_P1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Green Cross Corporation
Study Sponsor  ICMJE Green Cross Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Woo Joo Kim, M.D, Ph.D Korea University Guro Hospital
PRS Account Green Cross Corporation
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP