Fact CheckerSign in

NCT05297760CompletedPhase 1/2

Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract

Documentation of Efficacy for Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group, Double Blind Placebo-controlled Multisite Field Trial

Source: ClinicalTrials.gov · Last updated 21 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (actual)
First submitted
3 Mar 2022
Start date
10 Feb 2022
Primary completion date
28 Feb 2025
Lead sponsor
University of Zurich
Diseases
Asthma
NCT number
NCT05297760

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 60
  • From 10 Feb 2022 to the primary completion date, 28 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous grass pollen-specific immunotherapy.

Other illness

  • significant allergy to mugwort or pet animal allergens.
  • upper airway disease.
  • severe pulmonary disease.
  • recent allergic reactions.
  • cardiovascular disease.
  • malignant disease.
  • other diseases or conditions rendering the treatment of anaphylactic reactions difficult.

Other

  • uncontrolled asthma.
  • immunosuppression.
  • use of ACE-blockers.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Zurich
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.