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PPD Challenge for Tuberculosis

Phase < 1
Recruiting
Led By Kevin P Fennelly, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and agreement to use such a method during study participation
Male or female, aged 18 - 64 years of age
Must not have
History of pulmonary hypertension
Positive for COVID-19. (with-in 6 months prior to enrollment self-reported and or via PCR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how the cells within the lung react when exposed to PPD, in order to better understand tuberculosis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the bronchoscopy procedure such as sore throat or coughing; reactions at PPD application site; allergic responses to substances used during procedures like Lidocaine or Midazolam; and exposure risks associated with radioactive substance injection for imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during the study.
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I am between 18 and 64 years old.
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I do not have any major ongoing health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of high blood pressure in the lungs.
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I tested positive for COVID-19 within the last 6 months.
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I cannot stop taking blood thinners or aspirin for 7 to 14 days before a lung procedure.
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I cannot or will not undergo a bronchoscopy due to past issues or personal choice.
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I have coughed up blood in the past 3 months.
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I need extra oxygen when I am resting.
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I haven't taken immunosuppressive drugs, like steroids, in the last 6 months.
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I have a new lung infection.
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My radiation exposure in the last year is less than 2.3 rem.
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I have diabetes.
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I have a history of chronic lung disease or infections.
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I have symptoms like fever, chills, or unexplained weight loss.
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My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
pulmonary immune response to mycobacterial antigens
Secondary study objectives
location and longevity of immune cell activity in the pulmonary parenchyma and thoracic lymph nodes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
TST- IGRA-
Group II: 1Experimental Treatment1 Intervention
TST+ IGRA+
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tuberculin Purified Protein Derivative
N/A
~870

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,935 Previous Clinical Trials
47,792,231 Total Patients Enrolled
Kevin P Fennelly, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
900 Total Patients Enrolled
Ifeanyichukwu U Anidi, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
550 Total Patients Enrolled

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT05027958 — Phase < 1
Healthy Subjects Research Study Groups: 1, 2
Healthy Subjects Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT05027958 — Phase < 1
1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027958 — Phase < 1
~30 spots leftby Jan 2026
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