TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment

Treatments: Biological: TBE booster vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT02511535

TBE_1.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 3 patient groups

Allergic patients

Experimental group

Description:

Allergic patients receive TBE booster vaccination

Treatment:

Biological: TBE booster vaccination

Allergic patients with de-sensitization treatment

Experimental group

Description:

Allergic patients with de-sensitization treatment receive TBE booster vaccination

Treatment:

Biological: TBE booster vaccination

Healthy controls

Active Comparator group

Description:

Healthy controls receive TBE booster vaccination

Treatment:

Biological: TBE booster vaccination