Allergic RhinitisNCT04104828
Comparison of Innate Immune Responses Induced by Allergy Immunotherapy (AIT) With Different Adjuvants
An observational study of Allergic Rhinitis, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Allergovit, Polvac and Pollinex Quattro
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Nov 2019to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Allergovit, Polvac, Pollinex Quattro
- Keywords
- Allergy immunotherapy, Adjuvant, Innate immunity
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllergovitBiological
Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis
PolvacBiological
Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis
Pollinex QuattroBiological
Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis
| Study group | Role | What they receive |
|---|---|---|
| Grass/tree AIT with Allergovit | Collection of blood and data from patients that receive allergen-immunotherapy (AIT) with Allergovit, an aluminium-containing AIT preparations. Receives: Biological: Allergovit | |
| Grass/tree AIT with Polvac | Collection of blood and data from Patients that receive AIT with Polvac, an MCT-containing AIT preparation. Receives: Biological: Polvac | |
| 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. Receives: Biological: Pollinex Quattro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in inflammatory proteins in serum after AIT and as assessed using multiplex antibody arrays.
The primary objective is to measure a change in inflammatory responses in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. 80-150 inflammatory proteins will be tested using an antibody array. The primary objective of this pilot study is not necessarily to identify single proteins, but to identify patterns of inflammatory proteins that changes over the course of the study and which may be characteristics for the different adjuvants utilized. The results will therefore be described as heat maps with the different proteins presented in fold increase (green colour) or fold decrease (red color) as compared to baseline values.
Measured: 7 days
Secondary outcomes (10)
Aspartate transaminase in blood after AIT
The acute-phase enzyme aspartate transaminase (ASAT) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in ASAT (in U/l) compared to baseline values and which may be characteristics for the different adjuvants.
Measured: 7 days
Alanine aminotransferase in blood after AIT
The acute-phase enzyme alanine aminotransferase (ALAT) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in ALAT (in U/l) compared to baseline values and which may be characteristics for the different adjuvants.
Measured: 7 days
Gamma-glutamyltransferase in blood after AIT
The acute-phase protein gamma-glutamyltransferase (GGT) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in GGT (in U/l) compared to baseline values and which may be characteristics for the different adjuvants.
Measured: 7 days
C reactive protein in blood after AIT
The acute-phase protein C reactive protein (CRP) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by standard hospital laboratory methods. The objective is to identify changes in CRP (in mg/l) compared to baseline values and which may be characteristics for the different adjuvants.
Measured: 7 days
Interleukin-6 in blood after AIT
The acute-phase cytokine interleukin-6 (IL-6) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in IL-6 (in ng/l) compared to baseline values and which may be characteristics for the different adjuvants.
Measured: 7 days
Tryptase in blood after AIT
The acute-phase mast cell protein tryptase in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in tryptase (in µg/l) compared to baseline values and which may be characteristics for the different adjuvants.
Measured: 7 days
Immunoglobulin M (IgM) antibody responses after AIT
Allergen-specific IgM (in µg/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgM is measured by an in-house sandwich ELISA method.
Measured: Up to 7 weeks
Immunoglobulin G (IgG) antibody responses after AIT
Allergen-specific total IgG (in mg/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgG is measured by a standard hospital laboratory ELISA method.
Measured: Up to 7 weeks
Immunoglobulin G4 (IgG4) antibody responses after AIT
Allergen-specific IgG4 (in µg/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgG4 is measured by a standard hospital laboratory ELISA method.
Measured: Up to 7 weeks
Immunoglobulin E (IgE) antibody responses after AIT
Allergen-specific IgE (in kU/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgE is measured by a standard hospital laboratory ImmunopCap method.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start5 Nov 2019
- Primary completion31 Mar 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Zentrums für Rhinologie und Allergologie Wiesbaden
- Responsible party
- Principal investigator, Pal Johansen, University of Zurich
- Investigators
- Pål Johansen, Prof., PhD, Principal investigator, University Hospital Zürich & Unversity of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104828
- Sponsor's protocol ID
- USZ-AZW_MCT001
- Other IDs
- Basec no. 2019-01233
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29592962
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Innate Immune Responses Induced by Allergy Immunotherapy (AIT) With Different Adjuvants
- ClinicalTrials.gov ID
- NCT04104828
- Acronym / sponsor ID
- USZ-AZW_MCT001
- Conditions
- Allergic Rhinitis
- Keywords
- Allergy immunotherapy, Adjuvant, Innate immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Zentrums für Rhinologie und Allergologie Wiesbaden
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grass/tree AIT with Allergovit | – | Biological: AllergovitCollection of blood and data from patients that receive allergen-immunotherapy (AIT) with Allergovit, an aluminium-containing AIT preparations. |
| Grass/tree AIT with Polvac | – | Biological: PolvacCollection of blood and data from Patients that receive AIT with Polvac, an MCT-containing AIT preparation. |
| Grass/tree AIT with Pollinex Quattro | – | Biological: Pollinex QuattroCollection of blood and data from patients that receive AIT with Pollinex Quattro, an MCT-MPLA containing AIT preparation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllergovitGrass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis | Biological | Grass/tree AIT with Allergovit |
| PolvacGrass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis | Biological | Grass/tree AIT with Polvac |
| Pollinex QuattroGrass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis | Biological | Grass/tree AIT with Pollinex Quattro |
Primary outcome
Changes in inflammatory proteins in serum after AIT and as assessed using multiplex antibody arrays.
Time frame: 7 days
The primary objective is to measure a change in inflammatory responses in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. 80-150 inflammatory proteins will be tested using an antibody array. The primary objective of this pilot study is not necessarily to identify single proteins, but to identify patterns of inflammatory proteins that changes over the course of the study and which may be characteristics for the different adjuvants utilized. The results will therefore be described as heat maps with the different proteins presented in fold increase (green colour) or fold decrease (red color) as compared to baseline values.
10 secondary outcomes
Aspartate transaminase in blood after AIT
Time frame: 7 days
Alanine aminotransferase in blood after AIT
Time frame: 7 days
Gamma-glutamyltransferase in blood after AIT
Time frame: 7 days
C reactive protein in blood after AIT
Time frame: 7 days
Interleukin-6 in blood after AIT
Time frame: 7 days
Tryptase in blood after AIT
Time frame: 7 days
Immunoglobulin M (IgM) antibody responses after AIT
Time frame: Up to 7 weeks
Immunoglobulin G (IgG) antibody responses after AIT
Time frame: Up to 7 weeks
Immunoglobulin G4 (IgG4) antibody responses after AIT
Time frame: Up to 7 weeks
Immunoglobulin E (IgE) antibody responses after AIT
Time frame: Up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 29592962Leuthard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Johansen, Prof., PhD principal investigator
University Hospital Zürich & Unversity of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in inflammatory proteins in serum after AIT and as assessed using multiplex antibody arrays. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.