Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination

July 20, 2011 updated by: Medical University of Vienna

Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination

The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.

The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (≥18 years) of both sexes without upper age limit
  • Willingness to sign written informed consent form
  • Basic vaccination plus one booster (minimum) of TBE-vaccine,

Exclusion Criteria:

  • Age: < 18 years
  • Pregnancy or breast feeding
  • Prior TBE infection
  • Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
  • Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
  • History of autoimmune disease
  • Drug addiction
  • Plasma donators
  • Administration of other vaccines 4 weeks before/after day 0
  • Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period
  • Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses.
  • History of any malignant disease 5 years prior to the study entry
  • Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TBE low responder
Biological: TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Other Names:
  • FSME-Immun ATC code: J07 BA1
  • Inflexal ATC code: J07 BB02
Experimental: FSME responder
Biological: TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Other Names:
  • FSME-Immun ATC code: J07 BA1
  • Inflexal ATC code: J07 BB02
Experimental: hepatitis B non-responder
Biological: TBE vaccination and influenza vaccination
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
Other Names:
  • FSME-Immun ATC code: J07 BA1
  • Inflexal ATC code: J07 BB02

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
Time Frame: 7 days after TBE-booster plus influenza vaccination
7 days after TBE-booster plus influenza vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Ursula Wiedermann-Schmidt, MD, PhD, Institute of Specific Prophylaxis and Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimate)

December 8, 2008

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSME low-responder 1.1
  • EK Nr 474/2008 (Other Identifier: Ethics comitee, Medical University Vienna)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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