TuberculosisPhase 1NCT03363178
Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
A Phase 1 study testing GC3107 in people with Tuberculosis, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- GC3107
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2017to 31 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Woo Joo Kim, M.D. Ph.D., wjkim@korea.ac.kr
Woo Joo Kim, M.D. Ph.D.
About this study
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
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- GC3107
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3107Biological
BCG Vaccine, 0.1mL
| Study group | Role | What they receive |
|---|---|---|
| GC3107 | Experimental | BCG Vaccine, 0.1mL Receives: Biological: GC3107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Solicited/Unsolicited Adverse Event
Measured: for 7 days from Day0/during study period
Secondary outcomes (6)
Whether the maximum Induration diameter greater than 5mm after TST.
Induration diameter measured in the direction perpendicular to the arm.
Measured: Day0+84days
Whether the maximum Erythema/Redness diameter greater than 5mm after TST.
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Measured: Day0+84days
Maximum diameter of Induration after TST.
Induration diameter measured in the direction perpendicular to the arm.
Measured: Day0+84days
Maximum diameter of Erythema/Redness after TST.
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Measured: Day0+84days
Maximum diameter variation of Induration after TST.
Induration diameter measured in the direction perpendicular to the arm.
Measured: Day0+84days
Maximum diameter variation of Erythema/Redness after TST.
Erythema/Redness diameter measured in the direction perpendicular to the arm.
Measured: Day0+84days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start14 Dec 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo Joo Kim, M.D, Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363178
- Sponsor's protocol ID
- GC3107_P1
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03363178
- Acronym / sponsor ID
- GC3107_P1
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC3107 | Experimental | Biological: GC3107BCG Vaccine, 0.1mL |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC3107BCG Vaccine, 0.1mL | Biological | GC3107 |
Primary outcome
Adverse Event
Time frame: for 7 days from Day0/during study period
Solicited/Unsolicited Adverse Event
6 secondary outcomes
Whether the maximum Induration diameter greater than 5mm after TST.
Time frame: Day0+84days
Whether the maximum Erythema/Redness diameter greater than 5mm after TST.
Time frame: Day0+84days
Maximum diameter of Induration after TST.
Time frame: Day0+84days
Maximum diameter of Erythema/Redness after TST.
Time frame: Day0+84days
Maximum diameter variation of Induration after TST.
Time frame: Day0+84days
Maximum diameter variation of Erythema/Redness after TST.
Time frame: Day0+84days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Joo Kim, M.D, Ph.D principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC3107 in people with Tuberculosis, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoonjung Nam, Pharm.D (+81-260-9143, clairenam@greencross.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: for 7 days from Day0/during study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.