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The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumovax 23 | Experimental | Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumovax 23- pneumococcal polysaccharide | Biological | PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin G (IgG) Antibodies | Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL | 6 months post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Creo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39667114 | Derived | Ender E, Joshi A, Snyder M, Kumar S, Hentz R, Creo A. Seroconversion following PPSV23 vaccination in children with type 1 diabetes mellitus. Vaccine. 2025 Jan 25;45:126592. doi: 10.1016/j.vaccine.2024.126592. Epub 2024 Dec 11. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pneumovax 23 | Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) Pneumovax 23- pneumococcal polysaccharide: PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously. Blood draw: 6 ml blood draw at baseline and 6 months post immunization |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pneumovax 23 | Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) Pneumovax 23- pneumococcal polysaccharide: PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously. Blood draw: 6 ml blood draw at baseline and 6 months post immunization |
| 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 | Immunoglobulin G (IgG) Antibodies | Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL | Three subjects withdrew prior to the 6 months post vaccination blood draw and one subject withdrew prior to receiving the vaccine. | Posted | Median | Inter-Quartile Range | mcg/mL | 6 months post vaccination |
|
Adverse events were collected from baseline to end of study, approximately 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 | Pneumovax 23 | Type 1 Diabetes subjects received Pneumovax 23-pneumococcal polysaccharide (PPSV23) Pneumovax 23- pneumococcal polysaccharide: PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously. Blood draw: 6 ml blood draw at baseline and 6 months post immunization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana L. Creo, M.D. | Mayo Clinic | 507-284-3300 | Creo.Ana@mayo.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 | Apr 22, 2022 | Oct 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Will study immunological response to vaccination
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| Blood draw | Procedure | 6 ml blood draw at baseline and 6 months post immunization |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |