The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M. Tuberculosis
NCT ID: NCT06580639
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
280 participants
OBSERVATIONAL
2020-08-01
2025-12-01
Brief Summary
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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
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Study design: In this study we will include healthy donors (n=80), patient with active TB (n=40), subjects recently exposed to active TB (n=80) and patients with latent TB (LTBI) (n=80). 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Individuals
Patients with a negative IGRA (Quantiferon) who are apparently healthy.
No intervention.
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
Close contacts to patients with active TB
Close contacts to patients with active, smear positive pulmonary TB.
No intervention.
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
Patients with (latent) tuberculosis infection
Patients without active TB who have a positive IGRA (Quantiferon Plus) result.
No intervention.
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
Patients with active TB
Culture or PCR-verified active TB who are initiated on treatment.
No intervention.
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
Interventions
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No intervention.
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria:Known HIV infection, not Swedish citizen, chronic liver och kidney disease,immunosuppression from treatment or disease.
18 Years
ALL
Yes
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Thomas Schon
Professor
Principal Investigators
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Thomas Schoen, Professor
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Kalmar County Hospital
Kalmar, , Sweden
Dept of Infectious Diseases
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Thomas Schön, Professor
Role: primary
Thomas Schön, Professor
Role: primary
Other Identifiers
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2022-06858-02
Identifier Type: -
Identifier Source: org_study_id