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TBE Vaccination in Allergic Patients

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ClinicalTrials.gov Identifier: NCT02511535
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Univ. Prof. Dr. Ursula Wiedermann, 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.

Condition or disease Intervention/treatment Phase
Vaccine Responsiveness in Allergy Vaccine Responsiveness During Allergy De-sensitization Treatment Biological: TBE booster vaccination Phase 4

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 supressive cytokines. The investigators measure 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: TBE Vaccination in Allergic Patients
Study Start Date : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Allergic patients
Allergic patients receive TBE booster vaccination
Biological: TBE booster vaccination
Other Names:
  • Vaccine: FSME-Immun®
  • One dose (0.5 ml) contains:
  • 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudörfl),
  • 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®
  • One dose (0.5 ml) contains:
  • 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudörfl),
  • 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®
  • One dose (0.5 ml) contains:
  • 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudörfl),
  • adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+)
  • Manufacturer: Baxter Innovations GmbH




Primary Outcome Measures :
  1. Humoral TBE immunity [ Time Frame: one month after booster vaccination ]
    Geometric mean titers of TBE specific neutralizing Abs


Secondary Outcome Measures :
  1. Cellular immune response - cytokine production [ Time Frame: before (day 0) and 1week after booster vaccination ]
    cytokine production of ag-specifically re-stimunlated PMBC (interleukin 2, interferon gamma, interleukin 10, TNFalpha, interleukin 5)

  2. Cellular immune response - lymphocyte subpopulations [ Time Frame: before (day 0) and 1week after booster vaccination ]
    analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes

  3. TBE titer course [ Time Frame: before (day 0) until 6 months after booster vaccination ]
    Geometric mean titers of TBE specific neutralizing Abs are measured before (day 0) and one week, one month and 6 months after booster vaccination



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511535


Locations
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Austria
Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Ursula Wiedermann, MD, PhD Medical University Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Univ. Prof. Dr. Ursula Wiedermann, Univ.-Prof. Dr. Ursula Wiedermann, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02511535     History of Changes
Other Study ID Numbers: TBE_1.1
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs