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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03363178

Enrollment

Registered

2017-12-06

Start date

2017-12-14

Completion date

2018-03-31

Last updated

2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

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.

Interventions

BIOLOGICALGC3107

BCG Vaccine, 0.1mL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Adverse Event	for 7 days from Day0/during study period	Solicited/Unsolicited Adverse Event

Secondary

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

Countries

South Korea

Contacts

Primary ContactYoonjung Nam, Pharm.D

clairenam@greencross.com+81-260-9143

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026