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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystic Fibrosis | Experimental | Participants with Cystic Fibrosis. |
|
| Non Cystic Fibrosis Bronchiectasis | Experimental | Participants with Non Cystic Fibrosis Bronchiectasis. |
|
| Healthy Volunteer | Active Comparator | Participants with no condition (healthy volunteers). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG TICE Vaccine | Biological | Intradermal vaccination with BCG TICE |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria (CF and non-CF bronchiectasis):
Inclusion Criteria (Healthy Volunteers):
Exclusion Criteria (All arms):
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| Name | Affiliation | Role |
|---|---|---|
| Noah Lecthzin, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cystic Fibrosis | Participants with Cystic Fibrosis. BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
| FG001 | Non Cystic Fibrosis Bronchiectasis | Participants with Non Cystic Fibrosis Bronchiectasis. BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
| FG002 | Healthy Volunteer | Participants with no condition (healthy volunteers). BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data is presented for all patients enrolled that received BCG vaccination (N=30)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cystic Fibrosis | Participants with Cystic Fibrosis. BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
| BG001 | Non Cystic Fibrosis Bronchiectasis | Participants with Non Cystic Fibrosis Bronchiectasis. BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analyzed all participants enrolled | Posted | Mean | Standard Error | spot forming units | 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cystic Fibrosis | Participants with Cystic Fibrosis. BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noah Lechtzin | Johns Hopkins University | 410-502-7044 | 4102994561 | nlechtz@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Jan 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| BG002 | Healthy Volunteer | Participants with no condition (healthy volunteers). BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| SFU count | 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. | Mean | Standard Deviation | Spot forming units (SFU) |
|
| OG002 | Healthy Volunteer | Participants with no condition (healthy volunteers). BCG TICE Vaccine: Intradermal vaccination with BCG TICE |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 12 |
| 14 |
| EG001 | Non Cystic Fibrosis Bronchiectasis | Participants with Non Cystic Fibrosis Bronchiectasis. BCG TICE Vaccine: Intradermal vaccination with BCG TICE | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Healthy Volunteer | Participants with no condition (healthy volunteers). BCG TICE Vaccine: Intradermal vaccination with BCG TICE | 0 | 14 | 0 | 14 | 12 | 14 |
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| pustule | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001982 | Bronchial Diseases |