Rhinoconjunctivitis Due to Grass Pollen Allergy
Conditions
Brief summary
Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years. * Trial with immunodulatory product / biological
Interventions
BIOLOGICALAllergen specific immunotherapy
Sponsors
AlleCure
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * History of allergic rhino-conjunctivitis in spring and summer * Age 18 years to 65 years * Positive skin prick test to grass pollen
Exclusion criteria
* Blood donation within previous 30 days * Surgery within the previous 30 days * Use of investigational drugs within previous 90 days * Pregnancy or nursing * Mastocytosis * Significant cardiovascular disease * Hypertension * Active infectious disease * Significant hepatic disease * Significant renal disease * Significant hematological disorder * Significant pulmonary disease * Moderate or severe asthma * Autoimmune disease * History of malignancy. * Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety efficacy and toxicity | 3 years |
Countries
Switzerland
Outcome results
None listed