Trial Summary
What is the purpose of this trial?
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....
Research Team
Kevin P Fennelly, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
Adults aged 18-64, either exposed to TB without active disease or never exposed. Must be healthy with no significant medical issues like heart, lung, kidney diseases, etc., and agree to use effective contraception if of reproductive potential. Can't join if they need oxygen at rest, have HIV, poor tolerance for bronchoscopy, immunosuppressive conditions or medications usage in the last 6 months including steroids.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Tuberculin Purified Protein Derivative (PPD) (Vaccine)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
Dr. Gary H. Gibbons
National Heart, Lung, and Blood Institute (NHLBI)
Chief Executive Officer since 2012
MD from Harvard Medical School
Dr. James P. Kiley
National Heart, Lung, and Blood Institute (NHLBI)
Chief Medical Officer since 2011
MD from University of California, San Francisco