NCT04104828

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Allergovit	Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis
BIOLOGICAL	Polvac	Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis
BIOLOGICAL	Pollinex Quattro	Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis

Timeline

• Start date: 2019-11-05
• Primary completion: 2021-03-31
• Completion: 2021-10-31
• First posted: 2019-09-26
• Last updated: 2022-03-23

Locations

1 site across 1 country: Switzerland