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
1 other identifier
interventional
20
1 country
1
Brief Summary
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedDecember 18, 2017
November 1, 2017
4 months
November 30, 2017
December 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Event
Solicited/Unsolicited Adverse Event
for 7 days from Day0/during study period
Secondary Outcomes (6)
Whether the maximum Induration diameter greater than 5mm after TST.
Day0+84days
Whether the maximum Erythema/Redness diameter greater than 5mm after TST.
Day0+84days
Maximum diameter of Induration after TST.
Day0+84days
Maximum diameter of Erythema/Redness after TST.
Day0+84days
Maximum diameter variation of Induration after TST.
Day0+84days
- +1 more secondary outcomes
Study Arms (1)
GC3107
EXPERIMENTALBCG Vaccine, 0.1mL
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Woo Joo Kim, M.D, Ph.D
Korea University Guro Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2017
First Posted
December 6, 2017
Study Start
December 14, 2017
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
December 18, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share