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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tick Borne Encephalitis
• Intervention / Treatment: Biological: FSME vaccination (FSME-Immun)

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 Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • upper Austria
    • Linz, upper Austria, Austria, 4020
      • Elisabethinen Hospital
• Czech Republic
  • Ceske Budejovice, Czech Republic, 37087
    • Nemocnice Ceske Budejovice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1FSME vaccination; 2 vaccination on day 0	Biological: FSME vaccination (FSME-Immun); intra muscular 0.5 ml; Other Names: 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 Names: 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 Names: FSME-Immun 0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)

Secondary Outcome Measures

Outcome Measure	Time Frame
FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9	U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)

Collaborators and Investigators

• Sponsor: Elisabethinen Hospital
• Collaborators: Baxter Healthcare Corporation; ASOKLIF
• Investigators: Principal Investigator: Helmut Mittermayer, Elisabethinen Hospital

Publications and helpful links

Helpful Links

• ethics committee of the Elisabethinen hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Anticipated): November 1, 2009
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2009
• Last Update Submitted That Met QC Criteria: April 28, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: encephalitis; FSME; central european encephalitis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Tick-Borne Diseases; Encephalitis; Encephalitis, Tick-Borne
• Other Study ID Numbers: ASOKLIF 0608/MI; Eudract number: 2006-006955-10