Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (NCT04884308) | Clinical Trial Compass
CompletedPhase 2
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
United States30 participantsStarted 2021-04-28
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.