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

Phase 2

Completed

• Conditions: Cystic Fibrosis; Non-Tuberculous Mycobacteria; Bronchiectasis Adult
• Interventions: Biological: BCG TICE Vaccine

• Registration Number: NCT04884308
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-01
• Results First Submitted: 2025-01-16
• Results First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Results First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis	BCG TICE Vaccine	Participants with Cystic Fibrosis.
Non Cystic Fibrosis Bronchiectasis	BCG TICE Vaccine	Participants with Non Cystic Fibrosis Bronchiectasis.
Healthy Volunteer	BCG TICE Vaccine	Participants with no condition (healthy volunteers).

Primary Outcome Measures

Name	Time	Method
BCG Uptake	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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States