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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Vaccine Efficacy

Treatments: Biological: FSME-Immune vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT02511587

RV_FSME_1.2

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

intra muscular application

Active Comparator group

Description:

intra muscular application of FSME-Immune vaccination

Treatment:

Biological: FSME-Immune vaccination

subcutaneous application

Experimental group

Description:

subcutaneous application of FSME-Immune vaccination

Treatment:

Biological: FSME-Immune vaccination