Vaccine Responsiveness During Allergy De-sensitization Treatment Clinical Trial
Official title:
TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients
| Verified date | October 2019 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 119 |
| Est. completion date | September 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Humoral TBE Immunity | Geometric mean titers of TBE specific neutralizing Abs | one month after booster vaccination | |
| Secondary | Cellular Immune Response - Cytokine Production | cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5) | before (day 0) and 1week after booster vaccination | |
| Secondary | Cellular Immune Response - Lymphocyte Subpopulations | analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes | before (day 0) and 1week after booster vaccination | |
| Secondary | TBE Titer Course | Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination | before (day 0) until 6 months after booster vaccination |