Clinical trial NCT04064554: Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
BCG Vaccination
Keywords: Tuberculosis
BCG vaccination
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Experimental: BCG vaccination with MicronJet600
2. Comparator: BCG vaccination with conventional needle
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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.
* 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):

  1. Women(female?) in the menopause (non-therapy-induced amenorrhea for more than 12 months)
  2. Infertility due to surgery (without ovaries and/or uterus)
  3. If the female subject have sexual intercourse with only one male partner who has been confirmed to have no semen after fertilization
  4. 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.
  5. 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

Primary outcomes:
measure: Adverse Events
timeFrame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
measure: Adverse Events
timeFrame: during study period (Visit 3~Visit 6, 96 days)
Secondary outcomes:
measure: Average of usability VAS for medical device user
timeFrame: Visit 3 (day 1)
measure: Spot Forming Unit (SFU) per PBMC(Peripheral Blood Mononuclear Cells)
timeFrame: Visit 1(day -28~2)
measure: Spot Forming Unit (SFU) per PBMC
timeFrame: Visit 5(day 85±7)
measure: Delta log10 CFU
timeFrame: Visit 1(day -28~2)
measure: Delta log10 CFU
timeFrame: Visit 5(day 85±7)
measure: Mycobacterial antigen specific T-cell
timeFrame: Visit 1(day -28~2)
measure: Mycobacterial antigen specific T-cell
timeFrame: Visit 5(day 85±7)
measure: PPD test result (positive or negative) after application of medical device for clinical trial
timeFrame: Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
measure: Diameter of induration (mm) or presence or absence of blister
timeFrame: Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
measure: The diameter of the wheal
timeFrame: Visit 3 (day 1, after vaccination)
measure: Fraction of subjects eligible for each grade in the injection fluid leakage assessment at the injection site
timeFrame: Visit 3 (day 1, immediately after vaccination)
measure: Progress of normal reaction after BCG injection
timeFrame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
measure: Diameter of the scar after BCG injection
timeFrame: Visit 3(day 1, after vaccination) ~ Visit 6 (from 2 or 3 day of the Visit 5(day 85±7))
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Study officials:
References: