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

Phase 4

Completed

• Conditions: Vaccine Efficacy
• Interventions: Biological: FSME-Immune vaccination

• Registration Number: NCT02511587
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Results First Submitted: 2018-03-27
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-16
• Last Update Submitted: 2018-05-16
• Results First Posted: 2018-05-18
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intra muscular application	FSME-Immune vaccination	intra muscular application of FSME-Immune vaccination
subcutaneous application	FSME-Immune vaccination	subcutaneous application of FSME-Immune vaccination

Primary Outcome Measures

Name	Time	Method
Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine	1 month	GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination

Secondary Outcome Measures

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