Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle

NCT04064554 | Completed

• 1 other identifier: 1-2017-0073
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; BCG Vaccination

Keywords

Tuberculosis; BCG vaccination

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Frequency and characteristics of adverse events after applying medical devices for clinical trials (aspect, materiality, results, etc.)

  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.)

  during study period (Visit 3~Visit 6, 96 days)

Secondary Outcomes (13)

• Average of usability VAS for medical device user

  Visit 3 (day 1)

• Spot Forming Unit (SFU) per PBMC(Peripheral Blood Mononuclear Cells)

  Visit 1(day -28~2)

• Spot Forming Unit (SFU) per PBMC

  Visit 5(day 85±7)

• Delta log10 CFU

  Visit 1(day -28~2)

• Delta log10 CFU

  Visit 5(day 85±7)

Study Arms (2)

MicronJet600

EXPERIMENTAL

BCG vaccination with MicronJet600

Device: BCG vaccination with MicronJet600

Conventional needle

ACTIVE COMPARATOR

BCG vaccination with conventional needle

Device: BCG vaccination with conventional needle

Interventions

BCG vaccination with MicronJet600 DEVICE

BCG vaccination with MicronJet600

MicronJet600

BCG vaccination with conventional needle DEVICE

BCG vaccination with conventional needle

Conventional needle

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Subjects who voluntarily consented, after listening enough explanation for this study and the characteristics of medical devices and BCG vaccines.
• \) Adults from 19 to 35 years
• \) Tuberculin Skin Test negative
• \) QFT-GIT(QuantiFERON-TB Gold In-Tube) Test negative
• \) BMI from 19 to 35
• \) 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.)

You may not qualify if:

• \) 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.
• \) 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.
• \) A person who has not passed more than four weeks after the cure of virus infection (measles, mumps, chickenpox, and influenza).
• \) A case that the subject has skin abrasions, open wounds, wounds, or scars on the site where the medical devices for the clinical trial.
• \) 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.
• \) Patients with clinically significant arrhythmia difficult to participate in the clinical trial.
• \) 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.
• \) A person with a known history of diabetes or a person whose diabetes was confirmed by a test.
• \) 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).
• \) Patients with severe immunosuppressive disease: congenital immunodeficiency such as severe combined immunodeficiency (SCID); leukemia; lymphoma, etc.
• \) Patients with chronic renal insufficiency
• \) 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.
• \) A case that a person has hypersensitivity or anamnesis for constitutivity constituting BCG.
• \) 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)
• \) Patients receiving concomitant medications (Refer to section 5.2.3.3)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Experimental: BCG vaccination with MicronJet600 2. Comparator: BCG vaccination with conventional needle

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 22, 2019
• Study Start: December 1, 2017
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)