Clinical trial NCT00890422: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tick Borne Encephalitis
Keywords: encephalitis
FSME
central european encephalitis
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: ASOKLIF
First posted: 2009-04-29
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: 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
timeFrame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Secondary outcomes:
measure: FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9
timeFrame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Elisabethinen Hospital
state: upper Austria
city: Ceske Budejovice
country: Czech Republic
facility: nemocnice ceske Budejovice
Study officials:
affiliation: Elisabethinen Hospital
name: Helmut Mittermayer
role: PRINCIPAL_INVESTIGATOR
References: