Phase 4 N=119 Prevention

TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients

Vaccine Responsiveness in Allergy · Vaccine Responsiveness During Allergy De-sensitization Treatment

Bottom Line

View on ClinicalTrials.gov: NCT02511535 ↗

Enrolled (actual)

119

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Humoral TBE Immunity — 317.90; 250.10; 282.20 titer

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: TBE booster vaccination (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Medical University of Vienna
Primary completion: Feb 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02511535). 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.