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

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ClinicalTrials.gov Identifier: NCT00890422
Recruitment Status : Unknown
Verified April 2009 by Elisabethinen Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Tick Borne Encephalitis Biological: FSME vaccination (FSME-Immun) Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine
Study Start Date : March 2007
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1FSME vaccination
2 vaccination on day 0
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
Experimental: 2 FSME vaccination
1 vaccination on day 0 and one vaccination on day 4
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
Experimental: 3 FSME vaccination
2 vaccinations on day 0 and 1 vaccination on day 4
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml


Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56) ]

Secondary Outcome Measures :
  1. FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9 [ Time Frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

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): NCT00890422


Locations
Austria
Elisabethinen Hospital
Linz, upper Austria, Austria, 4020
Czech Republic
nemocnice ceske Budejovice
Ceske Budejovice, Czech Republic, 37087
Sponsors and Collaborators
Elisabethinen Hospital
Baxter Healthcare Corporation
ASOKLIF
Investigators
Principal Investigator: Helmut Mittermayer Elisabethinen Hospital
More Information

Additional Information:
Responsible Party: Helmut Mittermayer/Univ.Prof. Dr., Elisabethinen Hospital
ClinicalTrials.gov Identifier: NCT00890422     History of Changes
Other Study ID Numbers: ASOKLIF 0608/MI
Eudract number: 2006-006955-10
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by Elisabethinen Hospital:
encephalitis
FSME
central european encephalitis

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs