Clinical trial NCT02511535: TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Official title: TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccine Responsiveness in Allergy
Vaccine Responsiveness During Allergy De-sensitization Treatment
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Humoral TBE Immunity
timeFrame: one month after booster vaccination
Secondary outcomes:
measure: Cellular Immune Response - Cytokine Production
timeFrame: before (day 0) and 1week after booster vaccination
measure: Cellular Immune Response - Lymphocyte Subpopulations
timeFrame: before (day 0) and 1week after booster vaccination
measure: TBE Titer Course
timeFrame: before (day 0) until 6 months after booster vaccination
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Study officials:
affiliation: Medical University Vienna
name: Ursula Wiedermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.