Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal is to investigate the efficacy of intralymphatic immunotherapy (ILIT) for the treatment of allergic rhinitis and allergic asthma due to sensitisation to grass pollen allergens. 60 patients with allergic rhinitis will be included and randomized to receive either Polvac (n=30) or placebo (n=30). All patients will receive three injections with 4-8 weeks interval. The injections into a inguinal lymph node is guided by sonography.

Patients will record symptoms and medication use in the summer of 2022 and 2023.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborator: University of Aarhus

Criteria

Inclusion Criteria:

• passed online screening with a Rhinoconjunctivitis Total Symptom Score (RTSS) value of 8 or higher.

• sensitisation to grass pollen allergens with a skin prick test reaction to grass pollen allergen of 3 mm or more.

• eligible to allergen immunotherapy.

• 18 years or older.

• comfortable with digital data entry.

Exclusion Criteria:

• previous grass pollen-specific immunotherapy.

• significant allergy to mugwort or pet animal allergens.

• uncontrolled asthma.

• upper airway disease.

• severe pulmonary disease.

• recent allergic reactions.

• immunosuppression.

• cardiovascular disease.

• malignant disease.

• use of ACE-blockers.

• other diseases or conditions rendering the treatment of anaphylactic reactions difficult.