Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®

Study Overview
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Brief Summary
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FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

Detailed Description
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Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.

Official Title
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Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®

Conditions
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Vaccine Efficacy

Intervention / Treatment
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* Biological: FSME-Immune vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: completed primary TBE immunization + at least one booster immunization adults of both sexes between 18 and 60 years of age willingness to sign written informed consent form Exclusion Criteria: age < 18 and > 60 years prior TBE infection pregnancy and breast feeding acute infection on day of inclusion (day 0), (body temperature > 37,9°C) concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study administration of other vaccines 4 weeks before/after day 0 planned surgery within 2 weeks before/after TBE booster vaccination specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions history of malignant disease within the last 5 years autoimmune diseases drug addictions plasma donors receipt of blood transfusions or immuno globulins within 3 month before study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intra muscular application<br>intra muscular application of FSME-Immune vaccination | Biological: FSME-Immune vaccination<br>* booster vaccination with FSME-Immune<br>|
| Experimental: subcutaneous application<br>subcutaneous application of FSME-Immune vaccination | Biological: FSME-Immune vaccination<br>* booster vaccination with FSME-Immune<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine | GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular Immune Responses - Cytokines | cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma) | before (day 0) and 1 week after booster vaccination | 
| TBE Titer Profile | TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT) | before (day 0) and 1week, 1 month, 6 months after booster vaccination |