PPD Challenge for Tuberculosis

Recruiting in Palo Alto (17 mi)

Overseen by Kevin P Fennelly, M.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

No Placebo Group

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

I am between 18 and 64 years old.

I agree to use effective birth control during the study.

I am between 18 and 64 years old.

Exclusion Criteria

I have a history of high blood pressure in the lungs.

I do not have any immune system diseases, except for non-melanoma skin cancer.

I tested positive for COVID-19 within the last 6 months.

Treatment Details

Interventions

• Tuberculin Purified Protein Derivative (PPD) (Vaccine)

Trial Overview The trial is testing how lung cells respond to Tuberculin Purified Protein Derivative (PPD) when it's directly applied into the lungs via bronchoscopy instead of under the skin. Participants will undergo three bronchoscopies and FDG PET-CT scans over about a month with up to eight clinic visits.

Participant Groups

Group I: 2 Experimental Treatment 1 Intervention

TST- IGRA-

Group II: 1 Experimental Treatment 1 Intervention

TST+ IGRA+

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

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