Comparison of Innate Immune Responses Induced by Allergy Immunotherapy (AIT) With Different Adjuvants
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Hypersensitivity
Study type: Observational

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.
    

Intervention name(s): Allergovit; Polvac; Pollinex Quattro
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis; Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis; Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that will be considered for inclusion into the study should have been scheduled
        for AIT by means of subcutaneous injections of Allergovit® (USZ), Polvac (USZ), or
        Pol-linex Quattro (AZW), the goal being to include eight patients from each of the three
        treatment regimens.

        Important, the study subjects are only recruited among patients that are to receive their
        very first AIT. The AIT is not part of the study, but takes place due to prior decisions by
        the allergologists at USZ or at AZW.
      
Biospecimen description: 
      Venous blood will be collected for the determination of lab parameters. Whole blood analysis
      will be performed on blood collected on ethylenediaminetetraacetic acid (EDTA), while
      inflammatory proteins and antibodies are analysed from blood serum and blood plasma.
    
Keywords: Allergy immunotherapy; Adjuvant; Innate immunity