Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract
Primary Purpose
Rhinitis, Allergic, Seasonal, Rhinitis; Allergic, With Asthma, Allergic Rhinitis
Status
Active
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Polvac Grass+Rye
Saline 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal
Eligibility 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.
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Polvac
Placebo
Arm Description
Polvac Grass+Rye
Saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rhino conjunctivitis quality of life score (RQLQ)
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.
Lower airway disease
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.
Asthma
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.
Biomarkers
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.
Full Information
NCT ID
NCT05297760
First Posted
March 3, 2022
Last Updated
May 8, 2023
Sponsor
University of Zurich
Collaborators
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT05297760
Brief Title
Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract
Official Title
Documentation of Efficacy for Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group, Double Blind Placebo-controlled Multisite Field Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
Collaborators
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
In 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.
In 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.
For 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Rhinitis; Allergic, With Asthma, Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen, Allergic Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polvac
Arm Type
Active Comparator
Arm Description
Polvac Grass+Rye
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Biological
Intervention Name(s)
Polvac Grass+Rye
Intervention Description
Suspension of micro crystalline tyrosine with grass and rye pollen allergen
Intervention Type
Drug
Intervention Name(s)
Saline 0.9%
Intervention Description
Physiological saline solution for use as vehicle for the biological drug (Polvac Grass+Rye) or as placebo.
Primary Outcome Measure Information:
Title
Combined symptom medication score (cSMS)
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.
Time Frame
3 months (2 minutes per day)
Secondary Outcome Measure Information:
Title
Rhino conjunctivitis quality of life score (RQLQ)
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.
Time Frame
3 months (10 minutes per week)
Title
Lower airway disease
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.
Time Frame
10 minutes (5 times in two years)
Title
Asthma
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.
Time Frame
10 minutes (5 times in two years)
Title
Biomarkers
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.
Time Frame
5 minutes (8 times in two years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål Johansen, PhD
Organizational Affiliation
Univeristät Zürich, Dermatologische Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anonymous data can be shared on request by contacting the principle investigator. The shared info can include:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Citations:
PubMed Identifier
30391954
Citation
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Results Reference
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27253988
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Citation
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PubMed Identifier
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Citation
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Citation
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Links:
URL
https://ilit.nu
Description
Description of the current multicenter trial and registration platform for patient who would like to attend the trial
Learn more about this trial
Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract
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