Application of a TBE-Vaccine in obese persons

Phase 1

Conditions: Studies have shown that obesity has a direct effect on the immune system and leads to immunosuppression, which leads to a susceptibility to infection. The aim of this study is to clarify if a modification of vaccination schedules or a change of booster intervals is necessary for obese people. Furthermore this study will increase our understanding of the influence of obesity on different components of the immune system, as well as on the quality and quantity of the immune responses.
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2014-000570-19-AT

Lead Sponsor: Institute of Specific Prophylaxis and Tropical Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 148

Inclusion Criteria

•willingness to sign written informed consent form
•completed primary TBE immunization and at least 1 booster vaccination
•participants of both sexes between 18 and 60 years of age

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 74
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
•BMI 25-30
•previous TBE infection
•pregnancy or breast feeding
•acute infection on day of inclusion (day 0) or at visit 5 (36 months), body temperature > 37,9°C
•concomitant medications: systemic cortison therapy, chemotherapy, immunotherapy (allergy) immunsuppressive therapy 4 weeks prior or during the study
•administration of other vaccines 4 weeks before/after day 0
•planned surgery within 2 weeks before/after TBE booster
•any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
•malignant diseases within 5 years prior to the study
•autoimmune diseases
•kidney insufficiency, dialysis
•drug addiction
•plasma donor
•receipt of blood transfusions or immunoglobulins within 3 months prior to study entry / within 3 months prior to visit 5
•Severe disease with hospitalization or surgery 3 months before or during the study