Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine

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Brief Title

Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine

Official Title

Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine

Brief Summary

      The study aims to answer this question: whether adequate immunity can be achieved in a short
      time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation
      schedules? The investigators will test the immunogenicity (the degree of immunity achieved)
      of each of the immunisation schedules at various times after the injections. If the results
      of this clinical study are positive, it may then be possible to develop the most successful
      immunisation schedule so that it can be used routinely. This means that the results of the
      clinical study have an enormous practical value in preventing TBE in people travelling or
      moving into areas with a high TBE risk.
    

Detailed Description

      The data from at least 99 individuals will be needed if the study is to draw reliable
      conclusions. One-third of these individuals will receive 3 injections in all: 2 on the first
      day and the third injection 4 days later (immunisation schedule 1). Another one-third will
      receive 2 injections in all: one on the first day and one injection 4 days later
      (immunisation schedule 2). The remaining one-third will also receive 2 injections, both of
      these on the first day (immunisation schedule 3). Participants will be assigned completely
      randomly (by chance) to one of these three groups. So each participant stands a 33% chance (a
      1:2 chance) of receiving any one particular immunisation schedule. If you agree to take part,
      the process will be as follows:

      Brief Overview of the Course of the Clinical Study:

      Vaccination scheme 1

      Vaccination scheme 2

      Vaccination scheme 3

      Vaccinations:

      I = Vaccination with FSME-IMMUN 0,5ml

        -  Scheme 1: 2 vaccinations at U1 (day 0), one injection into the left and the right upper
           arm each, 1 vaccination at U2 (day 4), injection into the left upper arm

        -  Scheme 2: one vaccination at U1 (day 0) and at U2 (day 4), injections into the left
           upper arm each

        -  Scheme 3: 2 vaccinations at U1 (day 0), one injection into the left and the right upper
           arm each
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

achievement of FSME-Antibody-level (IgG) >25IU/ml at visit U2, U3, U4, U5, U6, U7, U8 and U9-yes/no achievement of FSME antibody-level (IgG) of >126VIEU/ml at U2, U3;U4, U5, U6, U7, U8 and U9-yes/no

Secondary Outcome

 FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9

Condition

Tick Borne Encephalitis

Intervention

FSME vaccination (FSME-Immun)

Study Arms / Comparison Groups

 1FSME vaccination
Description:  2 vaccination on day 0

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

99

Start Date

March 2007

Completion Date

July 2010

Primary Completion Date

November 2009

Eligibility Criteria

        Inclusion Criteria:

          -  written informed consent

          -  FSME antibody level < 7IU/ml (ELISA), retrospective

          -  FSME antibody (IgG) < 63 VIEU/ml (ELISA), retrospective

          -  FSME antibody (IgM) negative

          -  FSME antibody inhibition capacity <1:10-retrospective

          -  available for the next 56 days

        Exclusion Criteria:

          -  age not 19 or over 65

          -  pregnancy

          -  risk of becoming pregnant
      

Gender

All

Ages

19 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Helmut Mittermayer, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT00890422

Organization ID

ASOKLIF 0608/MI

Secondary IDs

Eudract number: 2006-006955-10


Study Sponsor

Elisabethinen Hospital

Collaborators

 Baxter Healthcare Corporation

Study Sponsor

Helmut Mittermayer, Principal Investigator, Elisabethinen Hospital


Verification Date

April 2009