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Clinical Trials/NCT03363178
NCT03363178UnknownPhase 1

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

Green Cross Corporation1 site in 1 country20 target enrollmentStarted: December 14, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
20
Locations
1
Primary Endpoint
Adverse Event
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
19 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

GC3107

Experimental

BCG Vaccine, 0.1mL

Intervention: GC3107 (Biological)

Outcomes

Primary Outcomes

Adverse Event

Time Frame: for 7 days from Day0/during study period

Solicited/Unsolicited Adverse Event

Secondary Outcomes

  • Whether the maximum Erythema/Redness diameter greater than 5mm after TST.(Day0+84days)
  • Maximum diameter of Erythema/Redness after TST.(Day0+84days)
  • Maximum diameter variation of Induration after TST.(Day0+84days)
  • Whether the maximum Induration diameter greater than 5mm after TST.(Day0+84days)
  • Maximum diameter of Induration after TST.(Day0+84days)
  • Maximum diameter variation of Erythema/Redness after TST.(Day0+84days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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