Vaccination against Tick borne Encephalitis (FSME-Immun®) in allergic patients

Phase 1

Conditions: Allergic patients have generally an altered immune-responsiveness (Th2 bias), and allergic individuals undergoing de-sensitization display an increased production of immune supressive cytokines. We investigate humoral and cellular immune responses to routine vaccination (TBE booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2012-005672-34-AT

Lead Sponsor: Institut für Spezifische Prophylaxe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 156

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 156
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
• prior 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 TBE vaccination
• planned surgery within 2 weeks before/after TBE vaccination

• Start of de-sensitization and the first 4 weeks of allergen dose escalation
• 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