Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05027958
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-08-28
Brief Title:
Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung
Status:
RECRUITING
Status Verified Date:
2024-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Tuberculosis TB is a lung disease It is caused by inhaling a type of airborne bacterium Tuberculin Purified Protein Derivative PPD is used to test for TB exposure It is usually injected under a person s skin In this study it will be applied in the lung
Objective
To learn how the cells within the lung react immune response when exposed to PPD
Eligibility
Adults ages 18-64 who 1 have been exposed to TB but do not have active disease or symptoms or 2 have never been exposed to TB
Design
Participants will be screened with a medical history physical exam and blood tests They will have a TB skin test They will also have an electrocardiogram to examine heart rhythm For this sticky patches will be placed on their chest
Some screening tests will be repeated at study visits
Participants will have 3 FDG PET-CT scans They will lie in a machine that creates pictures of the inside of their body They will get a radioactive substance injected into their arm called 18FDG It helps make the pictures
Participants will have 3 bronchoscopies Their mouth and nasal airways will be numbed They will get drugs to relax A tube will be inserted through their nose or mouth into a lung Fluid will be delivered into the lung and suctioned back out to collect cells They will get PPD during the first bronchoscopy
Participation will last for about 30 days Participants will visit the clinic up to 8 times They will go home after each procedure No hospital stays are needed
Tuberculosis TB is a lung disease It is caused by inhaling a type of airborne bacterium Tuberculin Purified Protein Derivative PPD is used to test for TB exposure It is usually injected under a person s skin In this study it will be applied in the lung
Objective
To learn how the cells within the lung react immune response when exposed to PPD
Eligibility
Adults ages 18-64 who 1 have been exposed to TB but do not have active disease or symptoms or 2 have never been exposed to TB
Design
Participants will be screened with a medical history physical exam and blood tests They will have a TB skin test They will also have an electrocardiogram to examine heart rhythm For this sticky patches will be placed on their chest
Some screening tests will be repeated at study visits
Participants will have 3 FDG PET-CT scans They will lie in a machine that creates pictures of the inside of their body They will get a radioactive substance injected into their arm called 18FDG It helps make the pictures
Participants will have 3 bronchoscopies Their mouth and nasal airways will be numbed They will get drugs to relax A tube will be inserted through their nose or mouth into a lung Fluid will be delivered into the lung and suctioned back out to collect cells They will get PPD during the first bronchoscopy
Participation will last for about 30 days Participants will visit the clinic up to 8 times They will go home after each procedure No hospital stays are needed
Detailed Description:
Study Description We propose a pilot study in which we employ directed bronchoscopic instillation of Mycobacterium tuberculosis Mtb-Tuberculin Purified Protein Derivative PPD to evaluate local airway immune response in adults with or without latent tuberculosis infection LTBI
Primary Objective The primary objective of this study is to understand the pulmonary immune response to mycobacterial antigens by determining the persistence of antigen-specific immune cells in the airways versus circulation after local bronchoscopic instillation of Tuberculin Purified Protein Derivative PPD into the lungs of adults with or without LTBI
Secondary Objective The secondary objective is to characterize the location and persistence of immune cell activity in the pulmonary parenchyma and thoracic lymph nodes with positron emission tomography combined with chest computed tomography PET-CT after bronchoscopic Tuberculin Purified Protein Derivative PPD instillation in adults with or without LTBI
Exploratory Objectives a An exploratory objective will be to perform phenotypic and functional analysis of immune cell populations in the airways vs circulation following bronchoscopic instillation of Tuberculin Purified Protein Derivative PPD into the lungs of individuals with or without LTBI b An additional exploratory objective will be to characterize the production of soluble mediators including but not limited to cytokines lipid mediators and defensins in BAL fluid vs blood within the same context
Endpoints
Primary Endpoint The primary endpoint will be the enumeration of Mtb antigen-specific CD4 and CD8 T cell populations in the airway and peripheral blood at early and late time points after bronchoscopic Tuberculin Purified Protein Derivative PPD instillation
Secondary Endpoint The secondary endpoint will be the quantification of 18Ffluoro-D-glucose FDG uptake in adjacent pulmonary parenchyma and draining thoracic lymph nodes via PET-CT at early and late time points after PPD instillation
Exploratory Endpoints a An exploratory endpoint will be the quantification of frequencies of cell surface molecules intracellular cytokines and transcription factors among immune cell populations in the airways vs circulation following bronchoscopic instillation of Tuberculin Purified Protein Derivative PPD into the lungs of individuals with or without LTBI b An exploratory endpoint will involve the identification and quantification of soluble mediators in the airway and peripheral blood after PPD instillation in the lungs within the same context
Primary Objective The primary objective of this study is to understand the pulmonary immune response to mycobacterial antigens by determining the persistence of antigen-specific immune cells in the airways versus circulation after local bronchoscopic instillation of Tuberculin Purified Protein Derivative PPD into the lungs of adults with or without LTBI
Secondary Objective The secondary objective is to characterize the location and persistence of immune cell activity in the pulmonary parenchyma and thoracic lymph nodes with positron emission tomography combined with chest computed tomography PET-CT after bronchoscopic Tuberculin Purified Protein Derivative PPD instillation in adults with or without LTBI
Exploratory Objectives a An exploratory objective will be to perform phenotypic and functional analysis of immune cell populations in the airways vs circulation following bronchoscopic instillation of Tuberculin Purified Protein Derivative PPD into the lungs of individuals with or without LTBI b An additional exploratory objective will be to characterize the production of soluble mediators including but not limited to cytokines lipid mediators and defensins in BAL fluid vs blood within the same context
Endpoints
Primary Endpoint The primary endpoint will be the enumeration of Mtb antigen-specific CD4 and CD8 T cell populations in the airway and peripheral blood at early and late time points after bronchoscopic Tuberculin Purified Protein Derivative PPD instillation
Secondary Endpoint The secondary endpoint will be the quantification of 18Ffluoro-D-glucose FDG uptake in adjacent pulmonary parenchyma and draining thoracic lymph nodes via PET-CT at early and late time points after PPD instillation
Exploratory Endpoints a An exploratory endpoint will be the quantification of frequencies of cell surface molecules intracellular cytokines and transcription factors among immune cell populations in the airways vs circulation following bronchoscopic instillation of Tuberculin Purified Protein Derivative PPD into the lungs of individuals with or without LTBI b An exploratory endpoint will involve the identification and quantification of soluble mediators in the airway and peripheral blood after PPD instillation in the lungs within the same context
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-H-0027 | None | None | None |