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

Tick Borne Encephalitis Clinical Trial

— immunisation  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00890422
• Other study ID #: ASOKLIF 0608/MI
• Secondary ID: Eudract number:
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: April 28, 2009
• Start date: March 2007
• Est. completion date: July 2010

Study information

• Verified date: April 2009
• Source: Elisabethinen Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick Borne Encephalitis

Intervention

Biological:
• FSME vaccination (FSME-Immun)
intra muscular 0.5 ml

Locations

Country	Name	City	State
Austria	Elisabethinen Hospital	Linz	upper Austria
Czech Republic	nemocnice ceske Budejovice	Ceske Budejovice

Sponsors (3)

Lead Sponsor	Collaborator
Elisabethinen Hospital	ASOKLIF, Baxter Healthcare Corporation

Countries where clinical trial is conducted

Austria,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes

External Links

•   ethics committee of the Elisabethinen hospital