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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03363178
• Other study ID #: GC3107_P1
• Status: Recruiting
• Phase: Phase 1
• First received: November 30, 2017
• Last updated: December 15, 2017
• Start date: December 14, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: November 2017
• Source: Green Cross Corporation
• Contact: Yoonjung Nam, Pharm.D
• Phone: +81-260-9143
• Email: clairenam[@]greencross.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• GC3107
BCG Vaccine, 0.1mL

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event	Solicited/Unsolicited Adverse Event	for 7 days from Day0/during study period
Secondary	Whether the maximum Induration diameter greater than 5mm after TST.	Induration diameter measured in the direction perpendicular to the arm.	Day0+84days
Secondary	Whether the maximum Erythema/Redness diameter greater than 5mm after TST.	Erythema/Redness diameter measured in the direction perpendicular to the arm.	Day0+84days
Secondary	Maximum diameter of Induration after TST.	Induration diameter measured in the direction perpendicular to the arm.	Day0+84days
Secondary	Maximum diameter of Erythema/Redness after TST.	Erythema/Redness diameter measured in the direction perpendicular to the arm.	Day0+84days
Secondary	Maximum diameter variation of Induration after TST.	Induration diameter measured in the direction perpendicular to the arm.	Day0+84days
Secondary	Maximum diameter variation of Erythema/Redness after TST.	Erythema/Redness diameter measured in the direction perpendicular to the arm.	Day0+84days