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Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations.
Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune suppressive cytokines. The investigators measure humoral and cellular immune responses to routine vaccination (Tick-borne Encephalitis [TBE] booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergic patients | Experimental | Allergic patients receive TBE booster vaccination |
|
| Allergic patients with de-sensitization treatment | Experimental | Allergic patients with de-sensitization treatment receive TBE booster vaccination |
|
| Healthy controls | Active Comparator | Healthy controls receive TBE booster vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBE booster vaccination | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral TBE Immunity | Geometric mean titers of TBE specific neutralizing Abs | one month after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular Immune Response - Cytokine Production | cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5) | before (day 0) and 1week after booster vaccination |
| Cellular Immune Response - Lymphocyte Subpopulations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ursula Wiedermann, MD, PhD | Medical University Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29673942 | Derived | Garner-Spitzer E, Seidl-Friedrich C, Zwazl I, Hofer M, Kinaciyan T, Jarisch R, Stiasny K, Zlabinger GJ, Kundi M, Wiedermann U. Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias. Vaccine. 2018 May 11;36(20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076. Epub 2018 Apr 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allergic Patients | Allergic patients receive TBE booster vaccination TBE booster vaccination |
| FG001 | Allergic Patients With De-sensitization Treatment | Allergic patients with de-sensitization treatment receive TBE booster vaccination TBE booster vaccination |
| FG002 | Healthy Controls | Healthy controls receive TBE booster vaccination TBE booster vaccination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allergic Patients | Allergic patients receive TBE booster vaccination |
| BG001 | Allergic Patients With De-sensitization Treatment | Allergic patients with de-sensitization treatment receive TBE booster vaccination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Humoral TBE Immunity | Geometric mean titers of TBE specific neutralizing Abs | Posted | Geometric Mean | 95% Confidence Interval | titer | one month after booster vaccination |
|
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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 | Allergic Patients | Allergic patients receive TBE booster vaccination | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaccine reactogenicity | Skin and subcutaneous tissue disorders | Systematic Assessment | local reactions to TBE vaccination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Garner-Spitzer, PhD | Med Uni Wien, Institut für Spezifische Prophylaxe und Tropenmedizin | 0043 1 40160 | 38255 | erika.garner-spitzer@meduniwien.ac.at |
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| ID | Term |
|---|---|
| C547297 | FSME-IMMUN vaccine |
| D004111 | Dimenhydrinate |
| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes |
| before (day 0) and 1week after booster vaccination |
| TBE Titer Course | Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination | before (day 0) until 6 months after booster vaccination |
| BG002 | Healthy Controls | Healthy controls receive TBE booster vaccination |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Cellular Immune Response - Cytokine Production | cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5) | the missing cytokine concentrations were not used for calculation because of invalid positive controls (due to poor PBMC [peripheral blood mononuclear cell] viability) | Posted | Geometric Mean | 95% Confidence Interval | pg/ml | before (day 0) and 1week after booster vaccination |
|
|
|
| Secondary | Cellular Immune Response - Lymphocyte Subpopulations | analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes | Posted | Mean | 95% Confidence Interval | percent of total lymphocytes | before (day 0) and 1week after booster vaccination |
|
|
|
| Secondary | TBE Titer Course | Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination | Posted | Mean | 95% Confidence Interval | fold change from d0 (before booster) | before (day 0) until 6 months after booster vaccination |
|
|
|
| 49 |
| 0 |
| 49 |
| 23 |
| 49 |
| EG001 | Allergic Patients With De-sensitization Treatment | Allergic patients with de-sensitization treatment receive TBE booster vaccination | 0 | 21 | 0 | 21 | 12 | 21 |
| EG002 | Healthy Controls | Healthy controls receive TBE booster vaccination | 0 | 49 | 0 | 49 | 27 | 49 |
|
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| D001559 |
| Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| IFNg 1 week post vacc |
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| IL-10 before vaccination |
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| IL-10 one week post vacc |
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| IL-2 before vaccination |
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| IL-2 one week post vacc |
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| IL-5 before vaccination |
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| IL-5 one week post vaccination |
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| B cells (CD19 +) at day 0 |
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| B cells (CD19 +) 1 week after booster vaccination |
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| T helper cells (CD4 +) at day 0 |
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| T helper cells (CD4 +) 1 week after booster |
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| cytotoxic T cells (CD8 +) at day 0 |
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| cytotoxic T cells (CD8 +) 1 week after booster |
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| Tregs (CD4+ FOXP3+) at day 0 |
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| Tregs (CD4+ FOXP3+) 1 week after booster |
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| fold change 4 weeks after booster |
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| fold change 6 month after booster |
|