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Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract

NCT05297760 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

  • Rhinitis, Allergic, Seasonal
  • Rhinitis; Allergic, With Asthma
  • Allergic Rhinitis
  • Allergic Rhinitis Due to Grass Pollen
  • Allergic Asthma

Interventions

BIOLOGICAL

Polvac Grass+Rye

Suspension of micro crystalline tyrosine with grass and rye pollen allergen

DRUG

Saline 0.9%

Physiological saline solution for use as vehicle for the biological drug (Polvac Grass+Rye) or as placebo.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Pål Johansen, PhD · Univeristät Zürich, Dermatologische Klinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297760 on ClinicalTrials.gov