Comparison of Innate Immune Responses Induced by Allergy Immunotherapy (AIT) With Different Adjuvants

NCT ID: NCT04104828

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2021-10-31

Brief Summary

The primary objective of the pilot study is to compare inflammatory responses in blood sera from patients receiving first allergen immunotherapy (AIT) with aluminium (Alum), microcrystalline tyrosine (MCT), or a combination of MCT and monophosphoryl lipid A (MPLA) as adjuvants. The AIT products are containing allergen extracts of grass and tree pollen). Blood is collected before as wells as one day, seven days, and 6-7 weeks after first AIT, and the blood is analysed for content of inflammatory proteins and antibodies.

Detailed Description

This pilot study is an observational study with subsequent use of coded biological material. The blood sera are collected and prepared at the Allergy Units at the University Hospital Zurich (USZ) or Centre for Rhinology and Allergology Wiesbaden (AZW). The AZW serum samples will be transferred to USZ for serological analysis. The AIT patients will be allocated to three arms based on their scheduled AIT. Two arms will be allocated to patients at the USZ Allergy Unit, while the last arm is allocated to patients at AZW.

Sixteen study subjects will be recruited from allergy patients that visit the Allergy Unit at USZ to receive AIT as part of standard of care treatment for their allergy. If the patients receive AIT, they can be included in the study. The decision on performing AIT is done by the USZ allergologist, and the therapy itself is not part of the current research project. The 16 USZ patients are split in two study arms. One arm of study subject is scheduled for grass/tree AIT with aluminium-containing "Allergovit", and the second arm is scheduled to receive grass/tree AIT with MCT-containing Polvac.

Eight study subjects will be recruited from allergy patients that visit the AZW to receive AIT as part of standard of care treatment for their allergy. If the patients receive AIT, they can be included in the study. The decision on performing AIT is done by the AZW allergologist, and the therapy itself is not part of the current research project. The 8 patients comprise the third arm of the overall study, and they receive grass/tree AIT with MCT- and MPLA-containing Pollinex Quattro.

Conditions

Allergic Rhinitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Grass/tree AIT with Allergovit

Collection of blood and data from patients that receive allergen-immunotherapy (AIT) with Allergovit, an aluminium-containing AIT preparations.

Allergovit

Intervention Type: BIOLOGICAL

Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis

Grass/tree AIT with Polvac

Collection of blood and data from Patients that receive AIT with Polvac, an MCT-containing AIT preparation.

Polvac

Intervention Type: BIOLOGICAL

Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis

Grass/tree AIT with Pollinex Quattro

Collection of blood and data from patients that receive AIT with Pollinex Quattro, an MCT-MPLA containing AIT preparation.

Pollinex Quattro

Intervention Type: BIOLOGICAL

Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis

Interventions

Allergovit

Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis

Intervention Type: BIOLOGICAL

Polvac

Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis

Intervention Type: BIOLOGICAL

Pollinex Quattro

Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• History of allergy due to IgE sensitisation to any allergen that is treatable by means of AIT, e.g. grass pollen allergens, three pollen allergens, animal dander allergens, dust mite aller-gens, or insect venom allergens.
• Scheduled to receive first AIT with Allergovit oder Polvac at USZ or to receive Pollinex Quattro at AZW.
• Signed written informed consent for subsequent use of coded blood samples including blood leukocytes data and serological data.

Exclusion Criteria

• Previous AIT
• Chronic inflammatory diseases (rheumatic diseases, pyelonephritis, osteomyelitis or others)
• Acute infections
• Drug or alcohol abuse within the last 5 years
• Relevant anaemia (as judged by investigator)
• Blood donation within the last 30 days or during the next 7 days
• Pregnancy or breast feeding
• Systemic glucocorticoid or antihistamine therapy within the last 30 days or during the next 7 days.
• Systemic or local immune drug therapy within the last 30 days during the next 7 days.
• For linguistic and/or cognitive reasons unable to understand the study procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zentrums für Rhinologie und Allergologie Wiesbaden

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Pal Johansen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pål Johansen, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zürich & Unversity of Zurich

Locations

Univeristy Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Leuthard DS, Duda A, Freiberger SN, Weiss S, Dommann I, Fenini G, Contassot E, Kramer MF, Skinner MA, Kundig TM, Heath MD, Johansen P. Microcrystalline Tyrosine and Aluminum as Adjuvants in Allergen-Specific Immunotherapy Protect from IgE-Mediated Reactivity in Mouse Models and Act Independently of Inflammasome and TLR Signaling. J Immunol. 2018 May 1;200(9):3151-3159. doi: 10.4049/jimmunol.1800035. Epub 2018 Mar 28.

Reference Type: BACKGROUND

PMID: 29592962 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: ICG Original and ethics approved (German)

View Document

Document Type: Informed Consent Form: Informed consent form (English translation)

View Document

Other Identifiers

Basec no. 2019-01233

Identifier Type: OTHER

Identifier Source: secondary_id

USZ-AZW_MCT001

Identifier Type: -

Identifier Source: org_study_id