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

January 16, 2025 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCG Uptake
Time Frame: 3 months
Change in concentration of interferon (IFN) gamma levels in blood after Bacille Calmette-Guérin (BCG) incubation relative to baseline as measured by SFUs. Spot forming units (SFU) is a measure of immune response of mononuclear cells in response to M. avium lysate. Higher values indicate a stronger immune response.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Noah Lecthzin, MD, MHS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00256425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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