Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Primary Purpose
Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BCG TICE Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Cystic Fibrosis focused on measuring BCG vaccine, Cystic fibrosis, Bronchiectasis, Non-tuberculosis mycobacteria
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.
Sites / Locations
- Johns Hopkins UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Cystic Fibrosis
Non Cystic Fibrosis Bronchiectasis
Healthy Volunteer
Arm Description
Participants with Cystic Fibrosis.
Participants with Non Cystic Fibrosis Bronchiectasis.
Participants with no condition (healthy volunteers).
Outcomes
Primary Outcome Measures
BCG Uptake
Change in concentration of IFNgamma levels in blood after BCG incubation relative to baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT04884308
First Posted
May 7, 2021
Last Updated
June 8, 2023
Sponsor
Johns Hopkins University
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04884308
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Cystic Fibrosis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
Keywords
BCG vaccine, Cystic fibrosis, Bronchiectasis, Non-tuberculosis mycobacteria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cystic Fibrosis
Arm Type
Experimental
Arm Description
Participants with Cystic Fibrosis.
Arm Title
Non Cystic Fibrosis Bronchiectasis
Arm Type
Experimental
Arm Description
Participants with Non Cystic Fibrosis Bronchiectasis.
Arm Title
Healthy Volunteer
Arm Type
Active Comparator
Arm Description
Participants with no condition (healthy volunteers).
Intervention Type
Biological
Intervention Name(s)
BCG TICE Vaccine
Intervention Description
Intradermal vaccination with BCG TICE
Primary Outcome Measure Information:
Title
BCG Uptake
Description
Change in concentration of IFNgamma levels in blood after BCG incubation relative to baseline.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Lecthzin, MD, MHS
Phone
410-502-7043
Email
nlechtz@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Lecthzin, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Lecthzin, MD, MHS
Phone
410-502-7043
Email
nlechtz@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
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