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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Tuberculosis

Intervention / Treatment
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* Biological: GC3107


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC3107<br>BCG Vaccine, 0.1mL | Biological: GC3107<br>* BCG Vaccine, 0.1mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Solicited/Unsolicited Adverse Event | for 7 days from Day0/during study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether the maximum Induration diameter greater than 5mm after TST. | Induration diameter measured in the direction perpendicular to the arm. | Day0+84days | 
| Whether the maximum Erythema/Redness diameter greater than 5mm after TST. | Erythema/Redness diameter measured in the direction perpendicular to the arm. | Day0+84days | 
| Maximum diameter of Induration after TST. | Induration diameter measured in the direction perpendicular to the arm. | Day0+84days | 
| Maximum diameter of Erythema/Redness after TST. | Erythema/Redness diameter measured in the direction perpendicular to the arm. | Day0+84days | 
| Maximum diameter variation of Induration after TST. | Induration diameter measured in the direction perpendicular to the arm. | Day0+84days | 
| Maximum diameter variation of Erythema/Redness after TST. | Erythema/Redness diameter measured in the direction perpendicular to the arm. | Day0+84days |