Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:22 AM
Study NCT ID:
NCT05297760
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined symptom medication score (cSMS)', 'timeFrame': '3 months (2 minutes per day)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Rhino conjunctivitis quality of life score (RQLQ)', 'timeFrame': '3 months (10 minutes per week)', 'description': 'Weekly questionnaire for studying the quality of life of the study participants during the pollen season of 2022 (and possible 2023 if the 2022 season is poor with low amounts of pollen). The RQLQ will assess seven domains on a weekly basis on a scale from 0 (best) to 6 (worst). The assessment is done over a long time period, but the records are integrated for the calculation of one single score (RQLC), which is the secondary outcome.'}, {'measure': 'Lower airway disease', 'timeFrame': '10 minutes (5 times in two years)', 'description': 'We will assess spirometry, at each follow-up time point (winter and summer visits) and analyse a time series of the development of each parameter in each treatment group. The assessments will be performed at several time-points and the changes from baseline assessments (before ILIT) is measured.'}, {'measure': 'Asthma', 'timeFrame': '10 minutes (5 times in two years)', 'description': 'We will assess FeNo (Fraction Exspiratory Nitric Oxide) at each follow-up time point (winter and summer visits) and analyse a time series of the development of each parameter in each treatment group. The assessments will be performed at several time-points and the changes from baseline assessments (before ILIT) are measured.'}, {'measure': 'Biomarkers', 'timeFrame': '5 minutes (8 times in two years)', 'description': 'Circulating levels of IgE, IgG1, and IgG4 specific for grass pollen extract and the major allergens Phl p 5 and Phl p 1 will be determined in blood samples before every treatment and at all the follow-up visits, for a total of 7 times per participant. The analysis is done using ImmunoCAP ELISA. In addition, IgE assessment by ISAC (112 allergens in one array) will be performed to analyse if sensitisation to other allergens develops or changes. All assessments will be performed at several time-points and the changes from baseline assessments (before ILIT) are measured.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Seasonal', 'Rhinitis; Allergic, With Asthma', 'Allergic Rhinitis', 'Allergic Rhinitis Due to Grass Pollen', 'Allergic Asthma']}, 'referencesModule': {'references': [{'pmid': '30391954', 'type': 'RESULT', 'citation': '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': '27253988', 'type': 'RESULT', 'citation': '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': '24934402', 'type': 'RESULT', 'citation': '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': '22464647', 'type': 'RESULT', 'citation': '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': '19680119', 'type': 'RESULT', 'citation': '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': '19001265', 'type': 'RESULT', 'citation': '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': '32679209', 'type': 'RESULT', 'citation': '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': '27231527', 'type': 'RESULT', 'citation': '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': '33099797', 'type': 'RESULT', 'citation': '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': '34429875', 'type': 'RESULT', 'citation': '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': '34187620', 'type': 'RESULT', 'citation': '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': '33647073', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://ilit.nu', 'label': 'Description of the current multicenter trial and registration platform for patient who would like to attend the trial'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients will record symptoms and medication use in the summer of 2022 and 2023.', 'detailedDescription': 'This study is part of a multicenter trial Phase III that takes place also in Denmark and Sweden (EudraCT registration number 2020-001060-28). 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.\n\nIn the Swiss arm of trial, Polvac (Allergy Therapeutics, United Kingdom) is applied. In Denmark and Sweden, the applied drug is Alutard (ALK, Denmark). The major difference is the excipient adjuvant, which is microcrystallin tyrosine (MCT) in Polvac aluminium in Alutard. The concentration of major allergen 60 phl p5, as the active ingredient, is the same in both products. The active ingredient is a standardised grass pollen allergen extract combined with MCT. The allergen extract has been treated with glutaraldehyd as to reduce allergenicity, i.e., increase the safety. In Switzerland and Germany, Bencard AG is providing the product. Polvac™, is a marketed product that is approved by the Swiss Medical Product Agencies and adheres to GMP. The product consists of needle-like crystalline structures of average 20 micrometer size. Polvac is approved for subcutaneous immunotherapy (SCIT), which consists of 6 pre-seasonal injections with 1-2 week intervals for 3-4 years, adding up to a total of 18 to 24 injections for the treatment to be completed.\n\nIn the currents study, 60 patients with allergic rhinitis will be included and randomized to receive either Polvac (n=30) or placebo (n=30). Primary screening is done online through questionnaires. Secondary screening and inclusion is done clinical at the University Hospital Zurich. All patients will receive three injections of Polvac or placebo (saline) with 4-8 weeks interval. The injections into a inguinal lymph node is guided by sonography.\n\nFor three days post each injections, adverse events will be recorded by patients using an on line application. In the summer seasons of 2022 and of 2023, the patients will record daily allergic symptoms and daily medication usage using an online application. These record are the basics for the efficacy analysis.\n\nAddition on January 12th 2024:\n\nAfter unblinding of the study in October to December 2023 and after analysis of the primary endpoint, it was decided to prolong the study in a semi-cross over. That means, study participants that received placebo in the original trial (n=30) will receive active treatment in an open label setting. The treatment will be exact similar to that of the active treatment in 2022, i.e., three ILIT injections of the IMD (Polvac Grass+Rye) with 4 weeks intervals and using the same dose as in 2022. The study participants that originally received active treatment (n=30) will not receive further treatment.\n\nAll patients (n=60), will be invited to enter symptoms and medication usage during the pollen season of 2024, similar to 2022 and 2023. In September to November 2024, the all patients will be invited for a final follow-up visit for clinical and laboratory tests. All patients will concent to the trial extension in writing prior to entering the trial extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* passed online screening with a Rhinoconjunctivitis Total Symptom Score (RTSS) value of 8 or higher.\n* sensitisation to grass pollen allergens with a skin prick test reaction to grass pollen allergen of 3 mm or more.\n* eligible to allergen immunotherapy.\n* 18 years or older.\n* comfortable with digital data entry.\n\nExclusion Criteria:\n\n* previous grass pollen-specific immunotherapy.\n* significant allergy to mugwort or pet animal allergens.\n* uncontrolled asthma.\n* upper airway disease.\n* severe pulmonary disease.\n* recent allergic reactions.\n* immunosuppression.\n* cardiovascular disease.\n* malignant disease.\n* use of ACE-blockers.\n* other diseases or conditions rendering the treatment of anaphylactic reactions difficult.'}, 'identificationModule': {'nctId': 'NCT05297760', 'briefTitle': 'Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Documentation of Efficacy for Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group, Double Blind Placebo-controlled Multisite Field Trial', 'orgStudyIdInfo': {'id': 'University Hospital Zurich'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Polvac', 'description': 'Polvac Grass+Rye', 'interventionNames': ['Biological: Polvac Grass+Rye']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Biological: Polvac Grass+Rye', 'Drug: Saline 0.9%']}], 'interventions': [{'name': 'Polvac Grass+Rye', 'type': 'BIOLOGICAL', 'otherNames': ['Polvac'], 'description': 'Suspension of micro crystalline tyrosine with grass and rye pollen allergen', 'armGroupLabels': ['Placebo', 'Polvac']}, {'name': 'Saline 0.9%', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Physiological saline solution for use as vehicle for the biological drug (Polvac Grass+Rye) or as placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Pål Johansen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristät Zürich, Dermatologische Klinik'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymous data can be shared on request by contacting the principle investigator. The shared info can include:\n\n* Study Protocol\n* Statistical Analysis Plan (SAP)\n* Informed Consent Form (ICF)\n* Clinical Study Report (CSR)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. sc.', 'investigatorFullName': 'Pal Johansen', 'investigatorAffiliation': 'University of Zurich'}}}}