Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract

NCT05297760 | Completed Phase 1 DMC

• 1 other identifier: University Hospital Zurich
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Combined symptom medication score (cSMS)

  Daily registration of symptoms and medication usage by the study participants and by means of a online application. This is done during the pollen season of 2022 (and possible 2023 if the 2022 season is poor with low amounts of pollen). The assessment is done over a time period, but the records are integrated for the calculation of one single score (cSMS), which is the primary outcome.

  3 months (2 minutes per day)

Secondary Outcomes (4)

• Rhino conjunctivitis quality of life score (RQLQ)

  3 months (10 minutes per week)

• Lower airway disease

  10 minutes (5 times in two years)

• Asthma

  10 minutes (5 times in two years)

• Biomarkers

  5 minutes (8 times in two years)

Study Arms (2)

Polvac

ACTIVE COMPARATOR

Polvac Grass+Rye

Biological: Polvac Grass+Rye

Placebo

PLACEBO COMPARATOR

Saline

Biological: Polvac Grass+Rye; Drug: Saline 0.9%

Interventions

Polvac Grass+Rye BIOLOGICAL

Suspension of micro crystalline tyrosine with grass and rye pollen allergen

Also known as: Polvac

Placebo; Polvac

Saline 0.9% DRUG

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years or older.
• comfortable with digital data entry.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• University of Aarhus: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (12)

• Senti G, Freiburghaus AU, Larenas-Linnemann D, Hoffmann HJ, Patterson AM, Klimek L, Di Bona D, Pfaar O, Ahlbeck L, Akdis M, Weinfeld D, Contreras-Verduzco FA, Pedroza-Melendez A, Skaarup SH, Lee SM, Cardell LO, Schmid JM, Westin U, Dollner R, Kundig TM. Intralymphatic Immunotherapy: Update and Unmet Needs. Int Arch Allergy Immunol. 2019;178(2):141-149. doi: 10.1159/000493647. Epub 2018 Nov 2.

  PMID: 30391954 RESULT

• Freiberger SN, Zehnder M, Gafvelin G, Gronlund H, Kundig TM, Johansen P. IgG4 but no IgG1 antibody production after intralymphatic immunotherapy with recombinant MAT-Feld1 in human. Allergy. 2016 Sep;71(9):1366-70. doi: 10.1111/all.12946. Epub 2016 Jun 17.

  PMID: 27253988 RESULT

• Zaleska A, Eiwegger T, Soyer O, van de Veen W, Rhyner C, Soyka MB, Bekpen C, Demiroz D, Treis A, Sollner S, Palomares O, Kwok WW, Rose H, Senti G, Kundig TM, Ozoren N, Jutel M, Akdis CA, Crameri R, Akdis M. Immune regulation by intralymphatic immunotherapy with modular allergen translocation MAT vaccine. Allergy. 2014 Sep;69(9):1162-70. doi: 10.1111/all.12461. Epub 2014 Jul 12.

  PMID: 24934402 RESULT

• Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.

  PMID: 22464647 RESULT

• Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7.

  PMID: 19680119 RESULT

• Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

  PMID: 19001265 RESULT

• Skaarup SH, Schmid JM, Skjold T, Graumann O, Hoffmann HJ. Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial. J Allergy Clin Immunol. 2021 Mar;147(3):1011-1019. doi: 10.1016/j.jaci.2020.07.002. Epub 2020 Jul 15.

  PMID: 32679209 RESULT

• Schmid JM, Nezam H, Madsen HH, Schmitz A, Hoffmann HJ. Intralymphatic immunotherapy induces allergen specific plasmablasts and increases tolerance to skin prick testing in a pilot study. Clin Transl Allergy. 2016 May 25;6:19. doi: 10.1186/s13601-016-0107-x. eCollection 2016.

  PMID: 27231527 RESULT

• Skaarup SH, Graumann O, Schmid J, Bjerrum AS, Skjold T, Hoffmann HJ. The number of successful injections associates with improved clinical effect in intralymphatic immunotherapy. Allergy. 2021 Jun;76(6):1859-1861. doi: 10.1111/all.14642. Epub 2020 Nov 16. No abstract available.

  PMID: 33099797 RESULT

• Aini NR, Mohd Noor N, Md Daud MK, Wise SK, Abdullah B. Efficacy and safety of intralymphatic immunotherapy in allergic rhinitis: A systematic review and meta-analysis. Clin Transl Allergy. 2021 Aug 17;11(6):e12055. doi: 10.1002/clt2.12055. eCollection 2021 Aug.

  PMID: 34429875 RESULT

• Werner MT, Bosso JV. Intralymphatic immunotherapy for allergic rhinitis: A systematic review and meta-analysis. Allergy Asthma Proc. 2021 Jul 1;42(4):283-292. doi: 10.2500/aap.2021.42.210028.

  PMID: 34187620 RESULT

• Hoang MP, Seresirikachorn K, Chitsuthipakorn W, Snidvongs K. Intralymphatic immunotherapy for allergic rhinoconjunctivitis: a systematic review and meta-analysis. Rhinology. 2021 Jun 1;59(3):236-244. doi: 10.4193/Rhin20.572.

  PMID: 33647073 RESULT

Related Links

• Description of the current multicenter trial and registration platform for patient who would like to attend the trial

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis; Rhinitis, Allergic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pål Johansen, PhD

  Univeristät Zürich, Dermatologische Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. sc.

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 28, 2022
• Study Start: February 10, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)