- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884308
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
January 16, 2024 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
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)
29
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 Contact
- Name: Noah Lecthzin, MD, MHS
- Phone Number: 410-502-7043
- Email: nlechtz@jhmi.edu
Study Locations
-
-
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.
|
Intradermal vaccination with BCG TICE
|
Experimental: Non Cystic Fibrosis Bronchiectasis
Participants with Non Cystic Fibrosis Bronchiectasis.
|
Intradermal vaccination with BCG TICE
|
Active Comparator: Healthy Volunteer
Participants with no condition (healthy volunteers).
|
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 IFNgamma levels in blood after BCG incubation relative to baseline.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Estimated)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Bronchial Diseases
- Genetic Diseases, Inborn
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Pancreatic Diseases
- Fibrosis
- Bronchiectasis
- Mycobacterium Infections
- Cystic Fibrosis
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- BCG Vaccine
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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