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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

Study Description
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Brief Summary:
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: GC3107 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GC3107
BCG Vaccine, 0.1mL
 Biological: GC3107
BCG Vaccine, 0.1mL


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Event [ Time Frame: for 7 days from Day0/during study period ]
    Solicited/Unsolicited Adverse Event


Secondary Outcome Measures :
  1. Whether the maximum Induration diameter greater than 5mm after TST. [ Time Frame: Day0+84days ]
    Induration diameter measured in the direction perpendicular to the arm.

  2. 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.

  3. Maximum diameter of Induration after TST. [ Time Frame: Day0+84days ]
    Induration diameter measured in the direction perpendicular to the arm.

  4. Maximum diameter of Erythema/Redness after TST. [ Time Frame: Day0+84days ]
    Erythema/Redness diameter measured in the direction perpendicular to the arm.

  5. Maximum diameter variation of Induration after TST. [ Time Frame: Day0+84days ]
    Induration diameter measured in the direction perpendicular to the arm.

  6. Maximum diameter variation of Erythema/Redness after TST. [ Time Frame: Day0+84days ]
    Erythema/Redness diameter measured in the direction perpendicular to the arm.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363178


Contacts
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Contact: Yoonjung Nam, Pharm.D +81-260-9143 clairenam@greencross.com

Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Woo Joo Kim, M.D. Ph.D.       wjkim@korea.ac.kr   
Principal Investigator: Woo Joo Kim, M.D. Ph.D.         
Sponsors and Collaborators
Green Cross Corporation
Investigators
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Principal Investigator: Woo Joo Kim, M.D, Ph.D Korea University Guro Hospital
More Information
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03363178    
Other Study ID Numbers: GC3107_P1
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections