TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

Phase 4

Completed

• Conditions: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment
• Interventions: Biological: TBE booster vaccination

• Registration Number: NCT02511535
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Primary Completion: 2016-02
• Study Completion: 2016-09
• Results First Submitted: 2019-07-08
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Results First Posted: 2019-10-25
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allergic patients with de-sensitization treatment	TBE booster vaccination	Allergic patients with de-sensitization treatment receive TBE booster vaccination
Allergic patients	TBE booster vaccination	Allergic patients receive TBE booster vaccination
Healthy controls	TBE booster vaccination	Healthy controls receive TBE booster vaccination

Primary Outcome Measures

Name	Time	Method
Humoral TBE Immunity	one month after booster vaccination	Geometric mean titers of TBE specific neutralizing Abs

Secondary Outcome Measures

Name	Time	Method
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
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
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)

Trial Locations

Locations (1)

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine; 🇦🇹 Vienna, Austria