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

Elisabethinen Hospital

Status and phase: Unknown; Phase 2

Conditions: Tick Borne Encephalitis

Treatments: Biological: FSME vaccination (FSME-Immun)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00890422

ASOKLIF 0608/MI

Eudract number: 2006-006955-10

Details and patient eligibility

About

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.

Full 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

Enrollment: 99 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

1FSME vaccination

Experimental group

Description:

2 vaccination on day 0

Treatment:

Biological: FSME vaccination (FSME-Immun)

2 FSME vaccination

Experimental group

Description:

1 vaccination on day 0 and one vaccination on day 4

Treatment:

Biological: FSME vaccination (FSME-Immun)

3 FSME vaccination

Experimental group

Description:

2 vaccinations on day 0 and 1 vaccination on day 4

Treatment:

Biological: FSME vaccination (FSME-Immun)