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

NCT03363178 — Phase 1, Unknown, 20 participants, Green Cross Corporation

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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

Registry	NCT03363178
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	20 (Estimated)
Sponsor	Green Cross Corporation (Industry)
Conditions	Tuberculosis
Interventions	GC3107 (Biological)
Dates	start 2017-12-14, primary completion 2018-03-31 (estimated), completion 2018-03-31 (estimated), first posted 2017-12-06, last updated 2017-12-18
Locations	1 site in South Korea

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
GC3107	Experimental	Biological: GC3107	BCG Vaccine, 0.1mL

GC3107 (Biological): BCG Vaccine, 0.1mL

+Outcome measures

Primary outcomes

Adverse Event [for 7 days from Day0/during study period]: Solicited/Unsolicited Adverse Event

Secondary outcomes

Whether the maximum Induration diameter greater than 5mm after TST. [Day0+84days]: Induration diameter measured in the direction perpendicular to the arm.
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.
Maximum diameter of Erythema/Redness after TST. [Day0+84days]: Erythema/Redness 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.

+Eligibility

Sex: All, ages: 19 Years to 64 Years, 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

+Locations (1)

Facility	City	Country	Status
Korea University Guro Hospital	Seoul	South Korea	Recruiting

+Investigators

Woo Joo Kim, M.D, Ph.D, Principal investigator, Korea University Guro Hospital

My Notes

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