Trial | NCT00890422  Report issue

Title

Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine
Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    99
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.
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 Started
Mar 31
2007
Primary Completion
Nov 30
2009
Anticipated
Study Completion
Jul 31
2010
Anticipated
Last Update
Apr 29
2009
Estimate

Biological FSME vaccination (FSME-Immun)

intra muscular 0.5 ml

  • Other names: FSME-Immun 0.5 ml

1FSME vaccination Experimental

2 vaccination on day 0

2 FSME vaccination Experimental

1 vaccination on day 0 and one vaccination on day 4

3 FSME vaccination Experimental

2 vaccinations on day 0 and 1 vaccination on day 4

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
No Results Posted