TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients

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.

Study Overview

• Status: Completed
• Conditions: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment
• Intervention / Treatment: Biological: TBE booster vaccination

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allergic patients; Allergic patients receive TBE booster vaccination	Biological: TBE booster vaccination; Other Names: 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
Experimental: Allergic patients with de-sensitization treatment; Allergic patients with de-sensitization treatment receive TBE booster vaccination	Biological: TBE booster vaccination; Other Names: 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
Active Comparator: Healthy controls; Healthy controls receive TBE booster vaccination	Biological: TBE booster vaccination; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Humoral TBE Immunity	Geometric mean titers of TBE specific neutralizing Abs	one month after booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular Immune Response - Cytokine Production	cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)	before (day 0) and 1week after booster vaccination
Cellular Immune Response - Lymphocyte Subpopulations	analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes	before (day 0) and 1week after booster vaccination
TBE Titer Course	Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination	before (day 0) until 6 months after booster vaccination

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Ursula Wiedermann, MD, PhD, Medical University Vienna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Immune System Diseases; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Tick-Borne Diseases; Hypersensitivity; Encephalitis; Encephalitis, Tick-Borne; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: TBE_1.1