NCT04884308CompletedPhase 2
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 7 May 2021
- Start date
- 28 Apr 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Johns Hopkins University
- Diseases
- Tuberculosis, Cystic fibrosis
- NCT number
- NCT04884308
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 28 Apr 2021 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Immunosuppressing drugs (including oral corticosteroids equivalent to \>10mg of prednisone for 5 days) in the 30 days prior to study enrollment
- Receipt of another investigational product in the last 28 days or planned receipt during this study
Other illness
- History of severe anaphylaxis to any vaccine or vaccine components
- History of organ/bone marrow transplantation or other immunosuppressing condition, including HIV
- Cirrhosis or portal hypertension
- 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.
Other
- Pregnant or breastfeeding
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.