Allergic patients have generally an altered immune-responsiveness (Th2 bias), and allergic individuals undergoing de-sensitization display an increased production of immune supressive cytokines. We investigate humoral and cellular immune responses to routine vaccination (TBE booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.
Conditions
Sponsors
Institut für Spezifische Prophylaxe
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 156 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • age 60 years • prior TBE infection • pregnancy and breast feeding • acute infection on day of inclusion (day 0), body temperature >37,9°C • concomitant medications: systemic cortison therapy, chemotherapy, immunesuppressive 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 adminstration 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster;Secondary Objective: TBE- titer course, cellular immune response;Primary end point(s): Humoral TBE immunity, based on TBE Neutralisation-Test titers ;Timepoint(s) of evaluation of this end point: one month after booster vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cellular immune response, TBE titer course;Timepoint(s) of evaluation of this end point: Cellular immune response - evaluated one week after vaccinations TBE titer course - titer evaluation before and one week, one month and 6 months after vaccinations | — |
Countries
Austria
Contacts
Public ContactISPTM, Clinical Trials Information
Institut für Spezifische Prophylaxe
Outcome results
None listed