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

• ClinicalTrials.gov Identifier: NCT03363178
• Recruitment Status: Unknown
• First Posted: December 6, 2017
• Last Update Posted: December 18, 2017
• Sponsor: Green Cross Corporation
• Information provided by (Responsible Party): Green Cross Corporation

Tracking Information

• First Submitted Date: November 30, 2017
• First Posted Date: December 6, 2017
• Last Update Posted Date: December 18, 2017
• Actual Study Start Date: December 14, 2017
• Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 30, 2017)

Adverse Event [ Time Frame: for 7 days from Day0/during study period ]

Solicited/Unsolicited Adverse Event

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Tuberculosis

Intervention

Biological: GC3107

BCG Vaccine, 0.1mL

Study Arms

Experimental: GC3107

BCG Vaccine, 0.1mL

Intervention: Biological: GC3107

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 30, 2017): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2018
• Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03363178
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Green Cross Corporation
• Study Sponsor: Green Cross Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Woo Joo Kim, M.D, Ph.D; Korea University Guro Hospital

• PRS Account: Green Cross Corporation
• Verification Date: November 2017