TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients
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All trials for Vaccine Responsiveness in Allergy All trials for Vaccine Responsiveness During Allergy De-sensitization Treatment All trials of TBE booster vaccination
-Summary
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.
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Allergic patients | Experimental | Biological: TBE booster vaccination | Allergic patients receive TBE booster vaccination |
| Allergic patients with de-sensitization treatment | Experimental | Biological: TBE booster vaccination | Allergic patients with de-sensitization treatment receive TBE booster vaccination |
| Healthy controls | Active comparator | Biological: TBE booster vaccination | Healthy controls receive TBE booster vaccination |
- TBE booster vaccination (Biological), also known as Vaccine: FSME-Immun® (Fruehsommer-Meningoencephalitis), One dose (0.5 ml) contains:, 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudoerfl),, adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+), Manufacturer: Baxter Innovations GmbH
+Outcome measures
Primary outcomes
- Humoral TBE Immunity [one month after booster vaccination]: Geometric mean titers of TBE specific neutralizing Abs
Secondary outcomes
- Cellular Immune Response - Cytokine Production [before (day 0) and 1week after booster vaccination]: cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)
- Cellular Immune Response - Lymphocyte Subpopulations [before (day 0) and 1week after booster vaccination]: analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes
- TBE Titer Course [before (day 0) until 6 months after booster vaccination]: Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination
+Eligibility
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
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
+Posted results
Participant flow
| Milestone | Allergic Patients | Allergic Patients With De-sensitization Treatment | Healthy Controls |
|---|
| Started | 49 | 21 | 49 |
| Completed | 49 | 21 | 49 |
| Not completed | 0 | 0 | 0 |
Outcome results
- Humoral TBE Immunity (Primary), Geometric mean, titer: Allergic Patients 317.90 (238.70 to 423.30); Allergic Patients With De-sensitization Treatment 250.10 (143.90 to 434.40); Healthy Controls 282.20 (210.60 to 378.20)
- Cellular Immune Response - Cytokine Production (Secondary), Geometric mean, pg/ml: Allergic Patients 37.85 (25.86 to 55.39); Allergic Patients With De-sensitization Treatment 42.54 (23.36 to 77.49); Healthy Controls 38.91 (25.13 to 59.01)
- Cellular Immune Response - Lymphocyte Subpopulations (Secondary), Mean, percent of total lymphocytes: Allergic Patients 69.3 (66.9 to 71.8); Allergic Patients With De-sensitization Treatment 73.7 (70.9 to 76.5); Healthy Controls 68.2 (65.5 to 71.0)
- TBE Titer Course (Secondary), Mean, fold change from d0 (before booster): Allergic Patients 1.46 (1.23 to 1.73); Allergic Patients With De-sensitization Treatment 1.80 (1.36 to 2.37); Healthy Controls 1.79 (1.50 to 2.14)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Allergic Patients | 0/49 (0.0%) | 0/49 (0.0%) | 23/49 (46.9%) |
| Allergic Patients With De-sensitization Treatment | 0/21 (0.0%) | 0/21 (0.0%) | 12/21 (57.1%) |
| Healthy Controls | 0/49 (0.0%) | 0/49 (0.0%) | 27/49 (55.1%) |
Other adverse events by term
| Term | Organ system | Allergic Patients | Allergic Patients With De-sensitization Treatment | Healthy Controls |
|---|
| vaccine reactogenicity | Skin and subcutaneous tissue disorders | 23/49 | 12/21 | 27/49 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine | Vienna | Austria | |
+Publications
- Results publication: 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. PMID 29673942
+Investigators