Adults 18 to 64, any sex, with Healthy or Latent Tuberculosis Infection (LTBI). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD)Primary· Day 5 and Day 21
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
Group
Value
95% CI
Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI)
5.26
3.99 – 11.5
Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI)
0.725
0.462 – 1.74
Day 21
Group
Value
95% CI
Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI)
29.9
19 – 37.3
Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI)
2.92
1.98 – 4.16
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 Days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI)
Serious: 0/7 (0%)
Deaths: 0/7
Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI)
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....
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06707207 — Predicting Future Errors During Skill Performance
· recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
· Phase 1
· recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.
· NA
· recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects
· NA
· recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
· Phase 1, PHASE2
· recruiting
Other National Heart, Lung, and Blood Institute (NHLBI) trials
Trials by the same sponsor.
NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease
· Phase 1
· not yet recruiting
NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System
· NA
· enrolling by invitation
NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti
· not yet recruiting
NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost
· Phase 1
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 6 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05027958.