TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients

Conditions
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Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment

Intervention / Treatment
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* Biological: TBE booster vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: completed primary TBE immunization + at least one booster immunization adults of both sexes between 18 and 60 years of age willingness to sign written informed consent form Exclusion Criteria: age < 18 and > 60 years prior TBE infection Hepatitis A vaccination pregnancy and breast feeding acute infection on day of inclusion (day 0), body temperature >37,9°C concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study administration of other vaccines 4 weeks before/after TBE vaccination planned surgery within 2 weeks before/after TBE vaccination Start of de-sensitization and the first 4 weeks of allergen dose escalation any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions history of malignant disease within the last 5 years autoimmune diseases drug addictions plasma donors receipt of blood transfusions or immuno globulins within 3 month before study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergic patients<br>Allergic patients receive TBE booster vaccination | Biological: TBE booster vaccination<br> <br> * Other names: Manufacturer: Baxter Innovations GmbH;|
| Experimental: Allergic patients with de-sensitization treatment<br>Allergic patients with de-sensitization treatment receive TBE booster vaccination | Biological: TBE booster vaccination<br> <br> * Other names: Manufacturer: Baxter Innovations GmbH;|
| Active Comparator: Healthy controls<br>Healthy controls receive TBE booster vaccination | Biological: TBE booster vaccination<br> <br> * Other names: Manufacturer: Baxter Innovations GmbH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral TBE Immunity | Geometric mean titers of TBE specific neutralizing Abs | one month after booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |