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Completed

NCT Number: NCT02511535

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TBE booster vaccination

Biological

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

Primary outcomes

  1. Humoral TBE Immunity

    Time frame: one month after booster vaccination

    Geometric mean titers of TBE specific neutralizing Abs

Secondary outcomes

  1. Cellular Immune Response - Cytokine Production

    Time frame: 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)

  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

    Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2015
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.