Status:
UNKNOWN
Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
Lead Sponsor:
Green Cross Corporation
Conditions:
Tuberculosis
Eligibility:
All Genders
19-64 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03363178
Start Date
December 14 2017
End Date
March 31 2018
Last Update
December 18 2017
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea