Clinical trial NCT04884308: Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Official title: Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Bronchiectasis Adult
Non-Tuberculous Mycobacteria
Keywords: BCG vaccine
Cystic fibrosis
Bronchiectasis
Non-tuberculosis mycobacteria
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2021-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 pre and post vaccination immune responses, BCG uptake and protection against infections, including nontuberculous mycobacteria (NTM). This study will also gather data on study feasibility, tolerability, and safety.

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.

Primary outcomes:
measure: BCG Uptake
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Noah Lecthzin, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: