NCT04884308

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cystic Fibrosis
• Bronchiectasis Adult
• Non-Tuberculous Mycobacteria

Interventions

Type	Name	Description
BIOLOGICAL	BCG TICE Vaccine	Intradermal vaccination with BCG TICE

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2021-05-12
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study