TuberculosisNCT04064554
Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle
A study testing BCG vaccination with MicronJet600 and BCG vaccination with conventional needle in people with Tuberculosis and BCG Vaccination, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and immunogenicity of Bacillus Calmette-Guerin (BCG) delivery via Novel Micronjet600 device compared to those via conventional needle. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, BCG Vaccination
- What is being tested?
- BCG vaccination with MicronJet600 and BCG vaccination with conventional needle
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 11 Sep 2019
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Subjects who voluntarily consented, after listening enough explanation for this study and the characteristics of medical devices and BCG vaccines.
- 2) Adults from 19 to 35 years
- 3) Tuberculin Skin Test negative
- 4) QFT-GIT(QuantiFERON-TB Gold In-Tube) Test negative
- 5) BMI from 19 to 35
- 6) A person who is determined to be suitable for the clinical trial as a result of the screening test.
- (Even if the physical, laboratory, imaging, or electrocardiogram results are out of the normal range, the subject may participate if he or she has provided a clear basis for participation at the discretion of the investigator.)
Who cannot join
- 1) A person with a history of tuberculosis based on the medical history and chest radiograph, or who is suspected or confirmed to have a tuberculosis infection.
- 2) A person who has active fever except for mild acute upper respiratory infection or localized skin infection other than the site to be treated, or who has a fever of 38 °C or more within 1 week before application of the medical devices for the clinical trial.
- 3) A person who has not passed more than four weeks after the cure of virus infection (measles, mumps, chickenpox, and influenza).
- 4) A case that the subject has skin abrasions, open wounds, wounds, or scars on the site where the medical devices for the clinical trial.
- 5) A person who is unable to evaluate the local adverse effect because of tattoo, etc. on the site where the medical device for clinical trial is to be applied.
- 6) Patients with clinically significant arrhythmia difficult to participate in the clinical trial.
Show all 36Show fewer
- 7) Patients with severe cardiac insufficiency (NYHA III and IV), a history of CABG(Coronary Artery Bypass Graft), and patients with cardiovascular diseases who are considered to be difficult to participate in the clinical trial.
- 8) A person with a known history of diabetes or a person whose diabetes was confirmed by a test.
- 9) Patients with hepatitis C or hepatitis B (in the case of hepatitis virus, healthy carriers may be participated at the discretion of the investigator) or positive for the serum test for human immunodeficiency virus (HIV).
- 10) Patients with severe immunosuppressive disease: congenital immunodeficiency such as severe combined immunodeficiency (SCID); leukemia; lymphoma, etc.
- 11) Patients with chronic renal insufficiency
- 12) A history of malignant tumors within 3 years excluding thyroid cancer (papillary, follicular, medullary types corresponding to Stage I or II), basal cell or squamous cell carcinoma on the skin, CIN(cervical intraepithelial neoplasia) and CIS(Carcinoma in situ) of the cervix, and intraepithelial carcinoma in other sites.
- 13) A case that a person has hypersensitivity or anamnesis for constitutivity constituting BCG.
- 14) Subjects who have not passed the predetermined period after receiving medication or treatment before the subjects participate in the clinical trial. (Refer to section 5.2.3.2)
- 15) Patients receiving concomitant medications (Refer to section 5.2.3.3)
- 16) A person who is unable to participate in the clinical trial period (about 6 months).
- 17) Patients scheduled for major surgery during the clinical trial.
- 18) A person who has a history of alcohol and other substance abuse for 6 months before screening.
- 19) Pregnant women or lactating women who are not willing to stop breastfeeding.
- 20) If the following are not applicable, (That is, you can only participate if):
- Women(female?) in the menopause (non-therapy-induced amenorrhea for more than 12 months)
- Infertility due to surgery (without ovaries and/or uterus)
- If the female subject have sexual intercourse with only one male partner who has been confirmed to have no semen after fertilization
- Female subjects who have agreed to abstinence during the clinical trial period
- If the subject is assured of abstinence throughout the clinical trial period (only if abstinence is voluntarily selected by the subject and abstinence is consistent with the general lifestyle of the subject: e.g., Priest)
- However, intermittent abstinence (e.g., ovulation, symptothermal method, or late ovulation) or external ejaculation is not a case of consent for abstinence.
- In the case of a woman who is in childbearing years, a woman who decides to use an effective method of contraception during the clinical trial period:
- Oral contraception
- Patch for contraception
- Intrauterine Contraceptive Device (IUD)
- Implant for contraception
- Injection for contraception (Time-released type)
- Hormone device in the uterus
- Tubal ligation and infertility surgery
- 21) Patient who has not passed 30 days since the date of signing the agreement of the previous clinical trial or who is currently participating in other clinical trial
- 22) Other diseases other than those listed above that the investigator deems inappropriate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: A Prospective, Randomized, Open-label, Single-centered Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle
The purpose of this study is to evaluate safety and immunogenicity of Bacillus Calmette-Guerin (BCG) delivery via Novel Micronjet600 device compared to those via conventional needle.
Read the detailed description
This study is designed as prospective, randomized, open-label, single-centered. In this study, healthy adults who meet inclusion criteria will be randomized and receive a BCG vaccine either using a conventional needle or MicronJet600 device. After vaccination, adverse events and progress will be observed.
- Conditions
- Tuberculosis, BCG Vaccination
- Being tested
- BCG vaccination with MicronJet600, BCG vaccination with conventional needle
- Keywords
- Tuberculosis, BCG vaccination
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG vaccination with MicronJet600Device
BCG vaccination with MicronJet600
BCG vaccination with conventional needleDevice
BCG vaccination with conventional needle
| Study group | Role | What they receive |
|---|---|---|
| MicronJet600 | Experimental | BCG vaccination with MicronJet600 Receives: Device: BCG vaccination with MicronJet600 |
| Conventional needle | Active comparator | BCG vaccination with conventional needle Receives: Device: BCG vaccination with conventional needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency and characteristics of adverse events after applying medical devices for clinical trials (aspect, materiality, results, etc.)
Measured: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Adverse Events
Frequency and characteristics of adverse events after applying medical devices for clinical trials (aspect, materiality, results, etc.)
Measured: during study period (Visit 3~Visit 6, 96 days)
Secondary outcomes (13)
Average of usability VAS for medical device user
The descriptive statistics (number of subjects, mean, standard deviation, median, minimum and maximum values) for the VAS(Visual Analogue Scale) scores measured at the time of the clinical device
- VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating pain).
If necessary, a significance assessment will be performed through an independent t-test or Wilcoxon rank-sum test, and generalized linear model.
Measured: Visit 3 (day 1)
Spot Forming Unit (SFU) per PBMC(Peripheral Blood Mononuclear Cells)
Ex vivo IFN(Interferon) γ ELISpot analysis to measure the number of T cells that secrete cytokines by mycobacterial antigen-specific immune response
Measured: Visit 1(day -28~2)
Spot Forming Unit (SFU) per PBMC
Ex vivo IFN γ ELISpot analysis to measure the number of T cells that secrete cytokines by mycobacterial antigen-specific immune response
Measured: Visit 5(day 85±7)
Delta log10 CFU
Delta log 10 CFU at each time point evaluated by Ex vivo Mycobacterial Growth Inhibition Assay (MGIA). Delta log10 CFU=log(CFU count of each sample tube/CFU count of the growth control tube/incubation indays)
Measured: Visit 1(day -28~2)
Delta log10 CFU
Delta log 10 CFU at each time point evaluated by Ex vivo Mycobacterial Growth Inhibition Assay (MGIA). Delta log10 CFU=log(CFU count of each sample tube/CFU count of the growth control tube/incubation indays)
Measured: Visit 5(day 85±7)
Mycobacterial antigen specific T-cell
For intracellular cytokine staining (ICS) assay testing, the investigators will evaluate IFN-γ and TNF(Tumor Necrosis Factor)-α as intracellular cytokines. To assess ICS, blood samples were drawn before PPD(Purified protein derivative) administration at Visit 1. ICS assay will be performed using FACS(fluorescence activated cell sorting)(Fluorescence Activated Cell Sorting). The fraction of cells that are positive for any of cytokines measured at each point will be evaluated by total T cells, T4 and T8 subtype cells.
Measured: Visit 1(day -28~2)
Mycobacterial antigen specific T-cell
For intracellular cytokine staining (ICS) assay testing, the investigators will evaluate IFN-γ and TNF-α as intracellular cytokines. To assess ICS, blood samples were drawn before PPD administration at Visit 5. ICS assay will be performed using FACS(Fluorescence Activated Cell Sorting). The fraction of cells that are positive for any of cytokines measured at each point will be evaluated by total T cells, T4 and T8 subtype cells.
Measured: Visit 5(day 85±7)
PPD test result (positive or negative) after application of medical device for clinical trial
The number of test subjects who showed positive reactions at the time of evaluation (V6) will be presented for each group.
Measured: Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Diameter of induration (mm) or presence or absence of blister
Descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum values) for the diameter of the mandible measured at the time of administration of the medical device for clinical use are presented for each application group.
Measured: Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
The diameter of the wheal
The diameter of the wheal at the injection site immediately after BCG vaccination If necessary, a significance assessment will be performed through an independent t-test or Wilcoxon rank-sum test, and generalized linear model.
Measured: Visit 3 (day 1, after vaccination)
Fraction of subjects eligible for each grade in the injection fluid leakage assessment at the injection site
The number of test subjects to the degree of leakage assessment observed following the application of the clinical trial medical device will be presented for each application group. If necessary, a significance assessment will be performed through a chi-square test or Fisher's exact test.
Measured: Visit 3 (day 1, immediately after vaccination)
Progress of normal reaction after BCG injection
The normal reaction of the injected site observed after application of the medical device for clinical use will be indicated for each application group.
Measured: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Diameter of the scar after BCG injection
Measured: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Dec 2017
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Experimental: BCG vaccination with MicronJet600 2. Comparator: BCG vaccination with conventional needle
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064554
- Sponsor's protocol ID
- 1-2017-0073
- Status last verified
- Dec 2019
- First submitted
- 5 Aug 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- 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 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Single-centered Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle
- ClinicalTrials.gov ID
- NCT04064554
- Acronym / sponsor ID
- 1-2017-0073
- Conditions
- Tuberculosis, BCG Vaccination
- Keywords
- Tuberculosis, BCG vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 22 Aug 2019 (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.
The purpose of this study is to evaluate safety and immunogenicity of Bacillus Calmette-Guerin (BCG) delivery via Novel Micronjet600 device compared to those via conventional needle.
Detailed description
This study is designed as prospective, randomized, open-label, single-centered. In this study, healthy adults who meet inclusion criteria will be randomized and receive a BCG vaccine either using a conventional needle or MicronJet600 device. After vaccination, adverse events and progress will be observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Experimental: BCG vaccination with MicronJet600 2. Comparator: BCG vaccination with conventional needle
| Arm | Type | Receives |
|---|---|---|
| MicronJet600 | Experimental | Device: BCG vaccination with MicronJet600BCG vaccination with MicronJet600 |
| Conventional needle | Active comparator | Device: BCG vaccination with conventional needleBCG vaccination with conventional needle |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1) Subjects who voluntarily consented, after listening enough explanation for this study and the characteristics of medical devices and BCG vaccines.
- 2) Adults from 19 to 35 years
- 3) Tuberculin Skin Test negative
- 4) QFT-GIT(QuantiFERON-TB Gold In-Tube) Test negative
- 5) BMI from 19 to 35
Key exclusion criteria (36 listed)
- 1) A person with a history of tuberculosis based on the medical history and chest radiograph, or who is suspected or confirmed to have a tuberculosis infection.
- 2) A person who has active fever except for mild acute upper respiratory infection or localized skin infection other than the site to be treated, or who has a fever of 38 °C or more within 1 week before application of the medical devices for the clinical trial.
- 3) A person who has not passed more than four weeks after the cure of virus infection (measles, mumps, chickenpox, and influenza).
- 4) A case that the subject has skin abrasions, open wounds, wounds, or scars on the site where the medical devices for the clinical trial.
- 5) A person who is unable to evaluate the local adverse effect because of tattoo, etc. on the site where the medical device for clinical trial is to be applied.
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 |
|---|---|---|
| BCG vaccination with MicronJet600BCG vaccination with MicronJet600 | Device | MicronJet600 |
| BCG vaccination with conventional needleBCG vaccination with conventional needle | Device | Conventional needle |
Primary outcome
Adverse Events
Time frame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Frequency and characteristics of adverse events after applying medical devices for clinical trials (aspect, materiality, results, etc.)
Adverse Events
Time frame: during study period (Visit 3~Visit 6, 96 days)
Frequency and characteristics of adverse events after applying medical devices for clinical trials (aspect, materiality, results, etc.)
13 secondary outcomes
Average of usability VAS for medical device user
Time frame: Visit 3 (day 1)
Spot Forming Unit (SFU) per PBMC(Peripheral Blood Mononuclear Cells)
Time frame: Visit 1(day -28~2)
Spot Forming Unit (SFU) per PBMC
Time frame: Visit 5(day 85±7)
Delta log10 CFU
Time frame: Visit 1(day -28~2)
Delta log10 CFU
Time frame: Visit 5(day 85±7)
Mycobacterial antigen specific T-cell
Time frame: Visit 1(day -28~2)
Mycobacterial antigen specific T-cell
Time frame: Visit 5(day 85±7)
PPD test result (positive or negative) after application of medical device for clinical trial
Time frame: Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Diameter of induration (mm) or presence or absence of blister
Time frame: Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
The diameter of the wheal
Time frame: Visit 3 (day 1, after vaccination)
Fraction of subjects eligible for each grade in the injection fluid leakage assessment at the injection site
Time frame: Visit 3 (day 1, immediately after vaccination)
Progress of normal reaction after BCG injection
Time frame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Diameter of the scar after BCG injection
Time frame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG vaccination with MicronJet600 and BCG vaccination with conventional needle in people with Tuberculosis and BCG Vaccination, run by Yonsei University 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 7 inclusion and 36 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: finished, as of the sponsor's last update on 5 Dec 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))). The study lists 2 primary outcomes in all. 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 5 Dec 2019.