NCT04884308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 10, 2025

Completed
Last Updated

February 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

May 7, 2021

Results QC Date

January 16, 2025

Last Update Submit

January 16, 2025

Conditions

Cystic FibrosisBronchiectasis AdultNon-Tuberculous Mycobacteria

Keywords

BCG vaccineCystic fibrosisBronchiectasisNon-tuberculosis mycobacteria

Outcome Measures

Primary Outcomes (1)

  • BCG Uptake

    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

Study Arms (3)

Cystic Fibrosis

EXPERIMENTAL

Participants with Cystic Fibrosis.

Biological: BCG TICE Vaccine

Non Cystic Fibrosis Bronchiectasis

EXPERIMENTAL

Participants with Non Cystic Fibrosis Bronchiectasis.

Biological: BCG TICE Vaccine

Healthy Volunteer

ACTIVE COMPARATOR

Participants with no condition (healthy volunteers).

Biological: BCG TICE Vaccine

Interventions

BCG TICE VaccineBIOLOGICAL

Intradermal vaccination with BCG TICE

Cystic FibrosisHealthy VolunteerNon Cystic Fibrosis Bronchiectasis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cystic FibrosisBronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial Diseases

Results Point of Contact

Title
Noah Lechtzin
Organization
Johns Hopkins University
nlechtz@jhmi.edu
410-502-7044

Study Officials

  • Noah Lecthzin, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 12, 2021

Study Start

April 28, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 10, 2025

Results First Posted

February 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)