Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle
NCT04064554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2019-12-05
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
Interventions
- DEVICE
-
BCG vaccination with MicronJet600
BCG vaccination with MicronJet600
- DEVICE
-
BCG vaccination with conventional needle
BCG vaccination with conventional needle
Sponsors & Collaborators
-
Yonsei University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-01
- Primary Completion
- 2019-09-11
- Completion
- 2019-09-11
Countries
- South Korea
Study Locations
More Related Trials
-
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG
NCT00427830 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans
NCT06845358 ·Status: WITHDRAWN ·Phase: PHASE1
-
Using BCG Vaccine to Understand Tuberculosis Infection
NCT05820594 ·Status: UNKNOWN ·Phase: NA
-
Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
NCT03363178 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers.
NCT00423566 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of GC3107(BCG Vaccine) in Healthy Infants
NCT03947138 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers
NCT00480688 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
NCT00480714 ·Status: COMPLETED ·Phase: NA
-
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route
NCT01181856 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of BCG Vaccination in the Prevention of COVID19 Via the Strengthening of Innate Immunity in Health Care Workers
NCT04384549 ·Status: UNKNOWN ·Phase: PHASE3
-
A BCG Challenge Model Study to Assess Anti-mycobacterial Immunity Induced by BCG and a Candidate TB Vaccine, MVA85A
NCT01194180 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
NCT07094711 ·Status: RECRUITING ·Phase: PHASE2
-
Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults
NCT01879163 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination
NCT00653627 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)
NCT00440544 ·Status: TERMINATED ·Phase: PHASE1
-
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
NCT02729571 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
γ-irradiated BCG to Train Innate Immunity
NCT02259608 ·Status: COMPLETED ·Phase: NA
-
A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A
NCT00653770 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Interaction Between BCG And MenC Immunisation: BAM
NCT02002156 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
NCT02378207 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of 2 Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Previously Vaccinated With BCG
NCT00465465 ·Status: COMPLETED ·Phase: PHASE1
-
The Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 Vaccines
NCT05507671 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality?
NCT04658680 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
NCT00456183 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
NCT02013245 ·Status: COMPLETED ·Phase: PHASE1