Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04884308
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04884308
Study Brief:
Protocol Section:
NCT04884308