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

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

Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis
• Intervention / Treatment: Biological: GC3107

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
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Woo Joo Kim, M.D. Ph.D.; Email: wjkim@korea.ac.kr
    • Principal Investigator: Woo Joo Kim, M.D. Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC3107; BCG Vaccine, 0.1mL	Biological: GC3107; BCG Vaccine, 0.1mL

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Woo Joo KIm, M.D, Ph.D, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Anticipated): March 31, 2018
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: GC3107_P1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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