| identifier: | SDY568 |
| description: |
This study will evaluate whether IBC-VSO1 vaccine, a synthetic metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction, protects against autoimmune attack in newly diagnosed type 1 diabetes patients. Halting beta-cell destruction may result in a prolonged remission and subsequent delay in diabetes related complications. Patients in this study must have been diagnosed with type 1 diabetes no more than 3 months prior to study enrollment.
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| aggregation: |
instance of dataset
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| refinement: |
2 - Complete set of descriptive data and results, as ascertained by ImmPort.
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| availability: |
available with registration
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| primaryPublications: |
19931408 |
| isAbout: |
Investigate safety and immunologic mechanisms of IBC-VSO1 vaccine and prevent or delay loss of pancreatic beta-cells in newly diagnosed type 1 diabetes patients.
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| clinical trial: | clinical trial |
| study category: | Autoimmune |
| study type: | Interventional |
| subject species: | Homo sapiens |
| biosample type: |
Serum Urine Whole blood |
| subject gender: | Both |
| assay type: |
| name: |
Diabetes Mellitus
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| fullName: |
Tihamer Orban
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| affiliations: |
Joslin Diabetes Center
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| roles: |
principal investigator
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| name: |
Orban ITN012AI: Evaluation of Diabetes Vaccine IBC-VSO1 in Newly Diagnosed Diabetics
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| size: |
12
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| name: |
Immune Tolerance Network
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| output: |
Safety assessment based on clinical endpoints: adverse events, local reactions, routine physical exams, insulin dose and laboratory tests. Additional endpoints include c-peptide levels in response to mixed meal tolerance test, HbA1c, GAD65Ab, IAA, IA2Ab, CD4-CD8- v-alpha 24jalphaQ+, IL-4 and INF-gamma T cell secretion
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| studyGroups: |
IBC-VSO1: IBC-VSO1 vaccine administered twice
Placebo-VSO2: Placebo-VSO2 administered twice
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| description: |
IBC-VSO1 vaccine, a synthetic metabolically inactive form of insulin is being evaluated as means of preventing pancreatic beta-cell destruction in newly diagnosed type 1 diabetes patients.
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| identifier: |
10.21430/M3IBWCGI97
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| startDate: |
2003-03-01
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| name: |
ImmPort
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| identifier: |
SCR:012804
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| homePage: |
http://www.immport.org |