Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections

Study Overview
=================
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.

Official Title
-----------------
Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers

Conditions
-----------------
Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria

Intervention / Treatment
-----------------
* Biological: BCG TICE Vaccine


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystic Fibrosis<br>Participants with Cystic Fibrosis. | Biological: BCG TICE Vaccine<br>* Intradermal vaccination with BCG TICE<br>|
| Experimental: Non Cystic Fibrosis Bronchiectasis<br>Participants with Non Cystic Fibrosis Bronchiectasis. | Biological: BCG TICE Vaccine<br>* Intradermal vaccination with BCG TICE<br>|
| Active Comparator: Healthy Volunteer<br>Participants with no condition (healthy volunteers). | Biological: BCG TICE Vaccine<br>* Intradermal vaccination with BCG TICE<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCG Uptake | Change in concentration of IFNgamma levels in blood after BCG incubation relative to baseline. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BCG vaccine, Cystic fibrosis, Bronchiectasis, Non-tuberculosis mycobacteria