TuberculosisMGIANCT06580639
The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M. Tuberculosis
An observational study of Tuberculosis and Immunologic Activity Alteration, run by Linkoeping University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Immunologic Activity Alteration
- How many people
- 280 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Aug 2020to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who are attending the infectious disease clinics at region Östergötland och region Kalmar, Sweden.
Inclusion Criteria: Healthy blood donors or subjects who will get vaccinated.
Exclusion Criteria:Known HIV infection, not Swedish citizen, chronic liver och kidney disease,immunosuppression from treatment or disease.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Kalmar County Hospital
Kalmar, 391 85
Thomas Schön, Professor, +46103850000, tschon@hotmail.com
- Recruiting
Dept of Infectious Diseases
Linköping, 581 85
Thomas Schön, Professor, +461010000000, tschon@hotmail.com
Jakob Paues, MD PhD
About this study
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.
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?
Read the 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 (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
- Tuberculosis, Immunologic Activity Alteration
- Being tested
- No intervention.
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Patients with a negative IGRA (Quantiferon) who are apparently healthy. Receives: Other: No intervention. | |
| Close contacts to patients with active TB | Close contacts to patients with active, smear positive pulmonary TB. Receives: Other: No intervention. | |
| Patients with (latent) tuberculosis infection | Patients without active TB who have a positive IGRA (Quantiferon Plus) result. Receives: Other: No intervention. | |
| Patients with active TB | Culture or PCR-verified active TB who are initiated on treatment. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycobacterial inhibition of host macrophages
Mycobacterial inhibition of host macrophages
Measured: Up to 10 days incubation
Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs)
Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs)
Measured: Up to 10 days incubation
Secondary outcomes (1)
Cytokine expression of host peripheral blood mononuclear cells (PBMCs)
Proteome analysis following exposure of PBMCs to gamma-irradiated M. tuberculosis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Aug 2020
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thomas Schon, Linkoeping University
- Investigators
- Thomas Schoen, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580639
- Sponsor's protocol ID
- 2022-06858-02
- Acronym
- MGIA
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06580639
- Acronym / sponsor ID
- MGIA / 2022-06858-02
- Conditions
- Tuberculosis, Immunologic Activity Alteration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | – | Other: No intervention.Patients with a negative IGRA (Quantiferon) who are apparently healthy. |
| Close contacts to patients with active TB | – | Other: No intervention.Close contacts to patients with active, smear positive pulmonary TB. |
| Patients with (latent) tuberculosis infection | – | Other: No intervention.Patients without active TB who have a positive IGRA (Quantiferon Plus) result. |
| Patients with active TB | – | Other: No intervention.Culture or PCR-verified active TB who are initiated on treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are attending the infectious disease clinics at region Östergötland och region Kalmar, Sweden.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis. | Other | Close contacts to patients with active TB, Healthy Individuals, Patients with (latent) tuberculosis infection, Patients with active TB |
Primary outcome
Mycobacterial inhibition of host macrophages
Time frame: Up to 10 days incubation
Mycobacterial inhibition of host macrophages
Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs)
Time frame: Up to 10 days incubation
Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs)
1 secondary outcome
Cytokine expression of host peripheral blood mononuclear cells (PBMCs)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schoen, Professor principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Immunologic Activity Alteration, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Schoen, Professor (+48013580000, tschon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycobacterial inhibition of host macrophages (time frame: Up to 10 days incubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.