Comparison of vaccination routes:Application of FSME-Immun® under the skin or into the muscle

Phase 1

Conditions: 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.
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2012-001453-74-AT

Lead Sponsor: Institute of Specific Prophylaxis and Tropical Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 116
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•age < 18 and > 60 years
•proir TBE infection
•pregnancy and breast feeding
•acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
•concomitant medications: systemic cortison therapy, chemotherapy, immunesuppressive 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 vacciantion
•spezific immunotherapy (Hypo-/Desensibilisierung) 14 days before/after vaccination
•any contraindication to adminstration 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