Overview

This trial is active, not recruiting.

Condition tick borne encephalitis
Treatment fsme vaccination (fsme-immun)
Phase phase 2
Sponsor Elisabethinen Hospital
Collaborator Baxter Healthcare Corporation
Start date March 2007
End date November 2009
Trial size 99 participants
Trial identifier NCT00890422, ASOKLIF 0608/MI, Eudract number: 2006-006955-10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
2 vaccination on day 0
fsme vaccination (fsme-immun) FSME-Immun 0.5 ml
intra muscular 0.5 ml
(Experimental)
1 vaccination on day 0 and one vaccination on day 4
fsme vaccination (fsme-immun) FSME-Immun 0.5 ml
intra muscular 0.5 ml
(Experimental)
2 vaccinations on day 0 and 1 vaccination on day 4
fsme vaccination (fsme-immun) FSME-Immun 0.5 ml
intra muscular 0.5 ml

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
time frame: 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
time frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)

Eligibility Criteria

Male or female participants from 19 years up to 65 years old.

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

Additional Information

Official title Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine
Principal investigator Helmut Mittermayer
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Elisabethinen Hospital.