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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884308
• Other study ID #: IRB00256425
• Status: Completed
• Phase: Phase 2
• Start date: April 28, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult
• Cystic Fibrosis
• Fibrosis
• Mycobacterium Infections
• Non-Tuberculous Mycobacteria

Intervention

Biological:
• BCG TICE Vaccine
Intradermal vaccination with BCG TICE

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCG Uptake	Change in concentration of IFNgamma levels in blood after BCG incubation relative to baseline.	3 months