Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580639
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M Tuberculosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M Tuberculosis From Healthy Blood Donors and Patients With Latent or Active Tuberculosis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MGIA
Brief Summary:
The goal of this observational study is to learn about how the blood leucocytes from patients with and without exposure or disease from tuberculosis TB are able to kill live mycobacteria M tuberculosis The main question it aims to answer is
Is intracellular growth suppression of M tuberculosis in peripheral blood mononuclear cells variable among healthy blood donors and higher than in patients with latent TB compared to active TB
Is intracellular growth suppression of M tuberculosis in peripheral blood mononuclear cells variable among healthy blood donors and higher than in patients with latent TB compared to active TB
Detailed Description:
Background The host immune response is crucial in determining the outcome after exposure to Mtb A substantial proportion of exposed individuals 40-70 never develop infection indicating an efficient cell mediated immune response against Mtb and early clearance by the host immune defense Verall et al Immunology 2014 Thus the outcome of exposure is highly dependent on host immunity In this study our aim was to investigate whether the previously developed mycobacterium groth inhibition assay MGIA method Andersson et al Tuberculosis 2020 could be used to quantify the host immune response to Mtb
Study design In this study we will include healthy donors n80 patient with active TB n40 subjects recently exposed to active TB n80 and patients with latent TB LTBI n80 Exclusion criteria for all groups are known HIV infection or other immunosuppression from treatment or disease Patients and healthy blood donors will be recruited at the departments of infectious diseases in Region Kalmar and Region Östergötland From patients giving oral and written consent 40 ml of blood will be collected for MGIA analysis
Primary aim To determine the difference in MGIA between healthy blood donors and patients with latent and active TB as well as the variation in host control of Mtb within each group
Method The Mycobacterial growth inhibition assay MGIA using human PBMCs isolated by density gradient by Lymhoprep Axis-Shield and SepMate tubes StemCell Technologies will be performed as described in study I with minor modifications The PBMCs are infected with GFP expressing M tuberculosis H37Rv and intracellular growth of Mtb and viability of PBMCs are assessed by live-cell imaging Incucyte and measured as relative fluorescence units RFU during 5 days with and without stimulation with the purified protein derivate PPD is included The cytokine response following exposure to gamma-irradiated H37Rv will be quantified by Olink proteomics
Study design In this study we will include healthy donors n80 patient with active TB n40 subjects recently exposed to active TB n80 and patients with latent TB LTBI n80 Exclusion criteria for all groups are known HIV infection or other immunosuppression from treatment or disease Patients and healthy blood donors will be recruited at the departments of infectious diseases in Region Kalmar and Region Östergötland From patients giving oral and written consent 40 ml of blood will be collected for MGIA analysis
Primary aim To determine the difference in MGIA between healthy blood donors and patients with latent and active TB as well as the variation in host control of Mtb within each group
Method The Mycobacterial growth inhibition assay MGIA using human PBMCs isolated by density gradient by Lymhoprep Axis-Shield and SepMate tubes StemCell Technologies will be performed as described in study I with minor modifications The PBMCs are infected with GFP expressing M tuberculosis H37Rv and intracellular growth of Mtb and viability of PBMCs are assessed by live-cell imaging Incucyte and measured as relative fluorescence units RFU during 5 days with and without stimulation with the purified protein derivate PPD is included The cytokine response following exposure to gamma-irradiated H37Rv will be quantified by Olink proteomics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None