Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Latent Tuberculosis Infection (LTBI)

Keywords

Tuberculin Purified Protein DerivativePPDantigen-specific immune cells in airways

Outcome Measures

Primary Outcomes (1)

Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD)
Median difference in CD4 cell response to intrabronchial instillation of Tuberculin Purified Protein Derivative (PPD) using flow cytometry. The frequency of (Mycobacterium tuberculosis) Mtb-specific T cells was measured by intracellular cytokine staining for Interferon Gamma (IFNγ) and Tumor Necrosis Factor (TNF) after in vitro restimulation of Peripheral Blood Mononuclear Cells (PBMC) and Bronchoalveolar Lavage (BAL) cells with PPD or Mtb-derived peptide megapools.
Day 5 and Day 21

Secondary Outcomes (1)

Median Difference in the Standard Uptake Value (SUV)
Baseline (Up to -7 days prior to PPD instillation), Day 4 and Day 20

Study Arms (2)

Arm 1: Healthy Volunteer Participants with confirmed Latent Tuberculosis Infection (LTBI)

OTHER

Healthy volunteer participants with confirmed Latent Tuberculosis Infection (LTBI) (TST positive and IGRA positive) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung.

Drug: Tuberculin Purified Protein Derivative

Arm 2: Healthy Volunteer Participants with confirmed non-Latent Tuberculosis Infection (LTBI)

OTHER

Healthy volunteer participants with confirmed non-Latent Tuberculosis Infection (LTBI) (TST negative and IGRA negative) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung.

Drug: Tuberculin Purified Protein Derivative

Interventions

Tuberculin Purified Protein DerivativeDrug

PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU

Arm 1: Healthy Volunteer Participants with confirmed Latent Tuberculosis Infection (LTBI)Arm 2: Healthy Volunteer Participants with confirmed non-Latent Tuberculosis Infection (LTBI)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Adults 18-64 years old will be recruited for the two groups (non-LTBI controls vs confirmed LTBI). The lower limit of this age range is based on the need for invasive bronchoscopic procedures and exposure to radiation, both of which carry more risk at younger ages. In addition, most adults present with post-primary or reactivation TB that most often occurs radiographically in the upper lobes of the lungs, often with cavitation. Conversely, children and rare adults with primary TB have non-cavitary disease in the lower lobes. The higher limit of this age range is based on the known property of immune senescence, i.e., the waning of the strength of immune responses with advancing age.

Sponsors & Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial Proteins

Results Point of Contact

Title: Kevin P. Fennelly, M.D., MPH, ATSF
Organization: Division of Intramural Research, NHLBI

Study Officials

Kevin P Fennelly, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NON RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 28, 2021

First Posted

August 31, 2021

Study Start

May 3, 2022

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm 1: Healthy Volunteer Participants with confirmed Latent Tuberculosis Infection (LTBI)

Arm 2: Healthy Volunteer Participants with confirmed non-Latent Tuberculosis Infection (LTBI)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations