NCT04064554

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis
• BCG Vaccination

Interventions

Type	Name	Description
DEVICE	BCG vaccination with MicronJet600	BCG vaccination with MicronJet600
DEVICE	BCG vaccination with conventional needle	BCG vaccination with conventional needle

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-09-11
• Completion: 2019-09-11
• First posted: 2019-08-22
• Last updated: 2019-12-05

Locations

1 site across 1 country: South Korea