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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Elisabethinen Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Baxter Healthcare Corporation
ASOKLIF
Information provided by:
Elisabethinen Hospital
ClinicalTrials.gov Identifier:
NCT00890422
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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 Intervention Phase
Tick Borne Encephalitis
Biological: FSME vaccination (FSME-Immun)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Elisabethinen Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 99
Study Start Date: March 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: April 28, 2009
Last Updated: April 28, 2009
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Elisabethinen Hospital:
encephalitis
FSME
central european encephalitis

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 01, 2014