Status:
COMPLETED
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Bronchiectasis Adult
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
Detailed Description
This single-site, open-label clinical trial to investigate the immune effects of BCG vaccination in adults with cystic fibrosis, non-cystic fibrosis bronchiectasis and healthy volunteers by measuring ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (CF and non-CF bronchiectasis):
- Confirmed diagnosis of either CF or non-CF bronchiectasis
- Forced expiratory volume over one second (FEV1) \> 40%
- Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
- Available for the study duration, including all planned follow-up visits
- Inclusion Criteria (Healthy Volunteers):
- Negative HIV enzyme-linked immunosorbent assay (ELISA) and confirmatory test at screening.
- Willingness to participate in the study after all aspects of the protocol have been explained and written informed obtained.
- Available for the study duration, including all planned follow-up visits
- Exclusion Criteria (All arms):
- Current or prior history of active or latent tuberculosis (TB) (per report, not formally tested) or NTM infection
- Prior BCG vaccination
- Previous vaccine in the past 4 weeks
- History of severe anaphylaxis to any vaccine or vaccine components
- History of organ/bone marrow transplantation or other immunosuppressing condition, including HIV
- Immunosuppressing drugs (including oral corticosteroids equivalent to \>10mg of prednisone for 5 days) in the 30 days prior to study enrollment
- Cirrhosis or portal hypertension
- Pregnant or breastfeeding
- Receipt of another investigational product in the last 28 days or planned receipt during this study
- Has any other condition that, in the opinion of the principal investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Exclusion
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04884308
Start Date
April 28 2021
End Date
December 30 2023
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287