Trials Sponsors Conditions Drugs Pricing

Conditions

Bronchiectasis Adult Cystic Fibrosis Non-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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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%

Sponsors & Collaborators

Cystic Fibrosis Foundation
Othercollaborator
Johns Hopkins University
Otherlead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

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

Study Officials

Noah Lecthzin, MD, MHS
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

30 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Cystic Fibrosis

Non Cystic Fibrosis Bronchiectasis

Healthy Volunteer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Cystic Fibrosis

Non Cystic Fibrosis Bronchiectasis

Healthy Volunteer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations