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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
15
BCG vaccination with MicronJet600
BCG vaccination with conventional needle
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul, South Korea
Adverse Events
Frequency and characteristics of adverse events after applying medical devices for clinical trials (aspect, materiality, results, etc.)
Time frame: 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.)
Time frame: during study period (Visit 3~Visit 6, 96 days)
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.
Time frame: 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
Time frame: 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
Time frame: 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)
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Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
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))