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

Green Cross Corporation

Status and phase

Unknown

Phase 1

Conditions

Tuberculosis

Treatments

Biological: GC3107

Study type

Interventional

Funder types

Industry

Identifiers

NCT03363178

GC3107_P1

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

19 to 64 years old

Volunteers

Accepts Healthy Volunteers

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