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

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04884308

Collaborator

Cystic Fibrosis Foundation (Other)

180

Enrollment

Location

Arms

26.1

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Bronchiectasis Adult Non-Tuberculous Mycobacteria	Biological: BCG TICE Vaccine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 28, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cystic Fibrosis Participants with Cystic Fibrosis.	Biological: BCG TICE Vaccine Intradermal vaccination with BCG TICE
Experimental: Non Cystic Fibrosis Bronchiectasis Participants with Non Cystic Fibrosis Bronchiectasis.	Biological: BCG TICE Vaccine Intradermal vaccination with BCG TICE
Active Comparator: Healthy Volunteer Participants with no condition (healthy volunteers).	Biological: BCG TICE Vaccine Intradermal vaccination with BCG TICE

Arm

Intervention/Treatment

Experimental: Cystic Fibrosis

Participants with Cystic Fibrosis.

Biological: BCG TICE Vaccine

Intradermal vaccination with BCG TICE

Experimental: Non Cystic Fibrosis Bronchiectasis

Participants with Non Cystic Fibrosis Bronchiectasis.

Biological: BCG TICE Vaccine

Intradermal vaccination with BCG TICE

Active Comparator: Healthy Volunteer

Participants with no condition (healthy volunteers).

Biological: BCG TICE Vaccine

Intradermal vaccination with BCG TICE

Outcome Measures

Primary Outcome Measures

BCG Uptake [3 months]
Change in concentration of IFNgamma levels in blood after BCG incubation relative to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.