Phase 4
Completed N=119
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Vaccine Responsiveness in Allergy · Vaccine Responsiveness During Allergy De-sensitization Treatment
Source: ClinicalTrials.gov NCT02511535 ↗
Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Humoral TBE Immunity — 317.90; 250.10; 282.20 titer
◆ Published Evidence
Emerging
17citations · ~2 / year
Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias.
Summary
Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations.
Linked Publications
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Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Humoral TBE Immunity |
317.90; 250.10; 282.20 | — |
| SECONDARY Cellular Immune Response - Cytokine Production |
37.85; 42.54; 38.91; 54.19; 59.45; 77.27 | — |
| SECONDARY Cellular Immune Response - Lymphocyte Subpopulations |
69.3; 73.7; 68.2; 68.7; 74.7; 70.6 | — |
| SECONDARY TBE Titer Course |
1.46; 1.80; 1.79; 3.02; 3.01; 2.56 | — |
Eligibility Criteria
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 60 years
- prior TBE infection
- Hepatitis A vaccination
- 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 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 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
Data sourced from ClinicalTrials.gov (NCT02511535) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.