TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Allergic patients

Allergic patients receive TBE booster vaccination

Group Type EXPERIMENTAL

TBE booster vaccination

Intervention Type BIOLOGICAL

Allergic patients with de-sensitization treatment

Allergic patients with de-sensitization treatment receive TBE booster vaccination

Group Type EXPERIMENTAL

TBE booster vaccination

Intervention Type BIOLOGICAL

Healthy controls

Healthy controls receive TBE booster vaccination

Group Type ACTIVE_COMPARATOR

TBE booster vaccination

Intervention Type BIOLOGICAL

Interventions

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TBE booster vaccination

Intervention Type BIOLOGICAL

Other Intervention Names

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes