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The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma

2019-09-27 06:30:41 | BioPortfolio

Summary

Aim: To investigate the possible immune modulatory effects of allergen immunotherapy (AIT) on respiratory immunity in patients with allergic asthma (AA).

Background: Allergic sensitization to aeroallergens is a common co-morbidity in asthma that is associated with more frequent and severe asthma attacks. We have recently shown that patients with allergic asthma also have an increased risk of pneumonia, and hence allergy in asthma may be associated with a relative respiratory immunodeficiency. However, the increased risk was obliterated in patients treated with AIT.

Methods: Patients with asthma sensitized to house-dust mite (HDM) is enrolled in a randomized, double-blind, placebo-controlled study of HDM-AIT. Patients will be scheduled for 9 visits through 8 months including, randomization to 6 months of treatment with either HDM-AIT (Acarizax/Odactra) or placebo. Primary interferons (IFN) type I and III will be investigated in human bronchial epithelial cells as the primary outcome. Secondary outcomes such as: Inflammatory cytokines, immunologic phenotype and immunohistochemistry will be investigated in bronchial biopsies, blood, bronchoalveolar lavage fluid, sputum and HDM-patch biopsies as well as a thorough respiratory and allergic evaluation.

Expected outcomes: We expect that, patients with AA have 1) decreased production of anti-viral type I and III IFN and that AIT increases these measures. 2) Anti-bacterial response is reduced through IL12, ß-defensin and IFN-γ and that AIT increases these measures. 3) Lastly, we expect that T-cell response is dysregulated (Th1↓1/Th2↑) in patients with AA and that these findings are modulated in an immuno-protective direction after AIT.

Perspectives: This project will expand our understanding of the clinical significance of allergy in asthma in a completely novel direction and show how AIT may modulate the immune response to prevent infections.

Description

1.1 Background Respiratory viral infections are the major cause of acute worsening of asthma. Importantly too, these infections may also predispose to bacterial infections. Patients with allergic asthma suffer from more frequent lower respiratory tract infections, more severe and longer lasting lower respiratory tract symptoms compared to healthy controls. Hence, the need to use antibiotics may reflect in part the increased susceptibility to viral infection in allergic asthma. We have recently demonstrated that patients with allergic asthma have an increased risk of being prescribed antibiotics for respiratory infections compared to non-allergic patients with asthma. Other studies have identified allergic sensitization and respiratory viral infections as synergetic risk factors in asthma exacerbations. These findings suggest a possible link between the allergic sensitization, asthma and an impaired immune response against respiratory infections. Furthermore, we have found that allergen-specific immunotherapy (AIT) reduces the risk of being prescribed antibiotics for respiratory infections in patients with allergic asthma. These novel observations make it of interest to investigate mechanistic pathways in target cells subjected to AIT.

In a recent study, investigating potential mechanisms involved in the interaction between allergen and viral infection we found that house dust mite (HDM) impairs viral stimulus (TLR3)-induced type I and type III interferons in bronchial epithelial cells from asthmatic patients and similarly in an in vivo mouse model of asthma exacerbation. This novel finding was accompanied with a direct effect of HDM on reducing TLR3 glycosylation6. Hence, HDM exposure in patients with allergic asthma may also contribute to a defect antiviral response by interfering with components important for the anti-viral signalling such as TLR3. Furthermore, we have observed that HDM has a capacity to induce over-expression of upstream Th2 cytokines such as IL-33, which may contribute to asthma exacerbations. In our studies HDM stands out amongst different allergens in causing both release of inflammatory inducing damage-associated metabolic patterns and impaired interferon response.

Inferentially, in this study we will have the unique opportunity to examine effects of human in vivo HDM-AIT on the bronchial epithelial cell production of type I and type III interferons as well as the balance between Th1/and Th2 inflammation in response to viral and bacterial triggers. We speculate that exposure to HDM-allergen may predispose to asthma exacerbations by causing dysregulation of the anti-viral interferon system as well as Th1/and Th2 inflammation and then that desensitization of patients with HDM-sensitive allergic asthma (AA) increases innate interferon response.

1.2 Hypothesis

1. Viral induced type I and type III IFN is increased in HBECS from patients with allergic asthma sensitized to HDM, after 24 weeks of Acarizax/Odactra.

2. Viral induced type I and III IFN response is impaired in HBECs from patients with allergic asthma sensitized to HDM, before 24 weeks of Acarizax/Odactra.

5. STUDY ASSESSMENTS 5.1 Efficacy Assessments

5.1.1 Medical history

Including (but not restricted to):

- Debut of asthma, allergy, asthma diagnosis (as stated in inclusion criteria), rhinitis and/or conjunctivitis, food allergy, atopic dermatitis/eczema, allergies to any medical products, previous medical illnesses, disposition to illness, expositions.

- A full list of prescribed medication, smoking history, daily/weekly alcohol consumption, date of birth, sex, race.

- Medicines and eventual changes in usual treatment.

- Informed consent to review medication history in FMK-online (common medicine card, online review).

Risk/discomfort: No risk or discomfort are associated with this.

5.1.2 Weight and Height

- Body weight measured to the nearest 0.1 kg wearing light indoors clothing and no shoes.

- Height measured to the nearest 1.0 cm. Risk/discomfort: No risk or discomfort are associated with this.

5.1.3 Spirometry Lung function will be measured using EasyOneTM (ndd Medical Technologies, Inc) according to ERS recommendations34. FEV1, FVC and FEV1/FVC will be recorded in the CRF.

Risk/discomfort: No risk or discomfort are associated with this.

5.1.4 FeNO FeNO levels will be measured online (rate, 0.05 L/s) with the Nitric Oxide Analyzer (Eco Medics) and according to American Thoracic Society guidelines.

Risk/discomfort: No risk or discomfort are associated with this.

5.1.5 Mannitol provocation

Dry-powder, inhaled mannitol (OsmohaleTM; Pharmaxis LTd, Frenchs Forest, NSW Australia) will be administered in increasing doses one minute apart (0, 5, 10, 20, 40, 80, 160, 160, 160 mg) and FEV1 will be recorded after each dose. The challenge will be stopped at a decrease in FEV1 of 15% or greater from baseline values (0 mg placebo capsule) or when the maximum cumulative dose of 635 mg has been administered. A positive test will be defined as a decrease in FEV1 of at least 15% after inhalation of 635 mg of mannitol or less. The provoking dose causing a 15% reduction in FEV1 (PD15) will be calculated. Response Dose Ratio will be calculated as: percent decrease in FEV1 / cumulative dose of mannitol administered.

Risk/discomfort: May cause transient shortness of breath, coughing or hoarseness.

5.1.6 Skin prick test A skin prick test to 10 aeroallergens (birch [Betula species], grass [Phleum pratense], mugwort, horse, dog, cat [Felis domesticus], house dust mite [Der p1 and Der f 2], and fungi [Alternaria and Cladosporium species; ALK-Abello´, Hoersholm, Denmark]) will be performed. Atopy will be defined as a positive skin prick test response (wheel diameter 1 + wheel diameter 2 / 2 = > 3 mm) to at least 1 of these 10 aeroallergens.

Risk/discomfort: No risk but may cause a transient itching.

5.1.7 Blood samples Samples for research purposes will be stored 1 hour (+/- 10 minutes) at room temperature, then processed and stored at minus 80 degrees Celsius (see SOP for blood samples for details). Hgb, leukocyte differential count, platelets, ALAT, bilirubin, INR, creatinine, sodium, potassium, immunoglobulins, tryptase, eosinophilic cationic protein, will be analysed at department of Clinical Biochemistry, Bispebjerg Hospital Risk/discomfort: No risk but the subject may cause a transient itching, get a small bruise and/or feel slight discomfort at the site of sampling.

5.1.8 Nose Swabs Two flocked swabs (FLOQSwabs Copan, Italy) are introduced alternately in one nostril, and rotated 6 times. Samples will be stored in transport medium at -80 degrees C. See SOP for full description of the procedure.

Risk/discomfort: No risk, but the subject may feel a slight itching in the nose.

5.1.9 Saliva samples SalivaBio Oral Swabs are placed under the tongue for approximately 5 minutes. Samples will be frozen immediately at -20 degrees before permanently stored at -80 degrees C.

Risk/discomfort: No risk or discomfort are associated with this.

5.1.10 Bronchoscopy BAL, bronchial brushings and mucosa biopsies will be collected during local anaesthesia and sedation with intravenous administered Midazolam and/or Fentanyl. If possible, entry will be through the nose, if this is not possible, entry will be through the mouth. Subjects will be closely monitored for at least 2 hours after bronchoscopy and will only be discharged when the effects of sedation and local anaesthesia disappear. Subjects will be provided with information regarding 24-hour emergency procedures.

Risk/discomfort:

5.1.11 Sampling at Bronchoscopy

1. Bronchial brushing will be performed in the left lower lobe. (See SOP for details).

2. BAL will be performed in segment 4 or 5 on the left side, installing up to 3 x 50ml of NaCl. Expected return will be 20-60 ml. (See SOP for details).

3. Biopsies will be taken from the right, middle lobar carinae and segmental carinae of the right lower lobe.

5.1.12 Procedures, assessment and analysis All experimental procedures, evaluations and analyses are performed blinded to the staff.

Brush biopsies: Immersed in RNAlater will be subject to RNA sequencing and analysed according to objectives and outcome measures as described in section 2.1 and 2.2 (See SOP for details). Investigations will be performed at the experimental laboratory of ass. Professor Lena Uller from the department of Respiratory immunopharmacology, University of Lund.

Bronchial biopsies: In fixative will be embedded in paraffin wax (See SOP for details). Samples will then be stored at room temperature before being analysed according to objectives and outcome measures as described in section 2.2 and 2.3 (See SOP for details). Histologic evaluation will be performed at the experimental laboratory of ass. Professor Lena Uller from the department of Respiratory immunopharmacology, University of Lund.

BAL-fluid: will be used for (including, but not limited to): 16S sequencing of airway microbiota, identify allergen specific antibodies, identify immunologic phenotype, using flowcytometry and/or ELISA (See SOP for details).

Nose swabs: Will be used for (including, but not limited to): Identification of: allergen specific antibodies, inflammatory biomarkers, immunologic phenotype, using flowcytometry and/or ELISA according to objectives and outcome measures described in 2.3 (See SOP for details).

HDM-patch punch biopsies: Will be used for (including, but not limited to): Single-cell sequencing on cells purified from the biopsies, immunohistochemical investigations, allergen-specific responses in vitro and analysed according to objective and outcome measures described in 2.3 (See SOP for details). Analysis and data-management will be performed at Dept. of Immunology and Microbiology, University of Copenhagen, under supervision of Professor Charlotte Bonefeld Menné.

BAL, blood and saliva: Will be transferred to ALK-Abello Global Reseach, cells will be isolated by dept. of Immunology and Microbiology and antibodies by ALK and will be used for (including, but not limited to): allergen-specific antibody analysis, and the bioinformatics related to data analysis. Any transfer or storage of data will be handled according to guidelines and legislation by The Danish Data Protection Agency and an agreement in accordance with guidelines and legislation by The Danish Data Protection Agency will be signed before any transfer of data.

5.1.13 ACQ-6 Standardized questionnaire Risk/discomfort: No risk or discomfort are associated with this.

5.1.14 AQLQ Standardized questionnaire Risk/discomfort: No risk or discomfort are associated with this.

5.1.15 TCRS Standardized questionnaire Risk/discomfort: No risk or discomfort are associated with this

5.1.16 EASI + POEM Standardized scoring tool and questionnaire for atopic dermatitis Risk/discomfort: No risk or discomfort are associated with this

5.1.17 Concomitant medication Subjects will at all visits be asked to provide information regarding additional medication throughout the study period. Drug, dose, time period and indication will be registered, including use of rescue medication (number of puff's per day / week).

Risk/discomfort: No risk or discomfort are associated with this.

5.1.18 HDM-Skin patch biopsy Subject are instructed at V1 to apply an HDM-patch (Dermatophagoides p) on the back 48 hours upon scheduled V2 and V7. Punch skin biopsies (5 mm) (n=2) are obtained from the Der-p exposed inflamed site and vehicle exposed skin. Biopsies will immediately be immersed in fixative (4% formaldehyde) and then processed for paraffin embedding or placed in 1mL of medium for subsequent purification of immune cells from the biopsies (See SOP for details). Analysis and data management will be performed at Dep. of Immunology and Microbiology, University of Copenhagen, Denmark under the supervision of Prof. Charlotte Menné Bonefeld.

Risk/discomfort: No risks but subject may experience itching and erythema at the site of HDM-patch. Punch biopsy may result in itching, swelling and minor soreness at the sample site.

5.1.19 Induced sputum Selected sputum plugs will be stored into RNAlater for later mRNA analysis. Sputum processing follow a protocol that secure supernatant before and after adding 0.1% dithiothreitol (see SOP for further details). A viability assessment will be performed on 10 micro liter of filtered solution dyed with Trypan Blue. The rest of the solution will be centrifuged for 10 minutes at 2000 rpm (600 g) and at 4°C, the supernatant will be removed, and cytospins prepared and stained. Samples with a minimum count of 100 non-squamous cells will be included in the analysis. Sputum will also be analysed using flowcytometri.

Risk/discomfort: No risk or discomfort are associated with this.

5.1.20 Evaluation of adherence Adherence is evaluated continuously throughout intervention period. Patients fill out a standardized diary for the use of medication.

Adherence is calculated in % by end of study.

Risk/discomfort: No risk or discomfort are associated with this.

5.1.21 Photographic evaluation of atopic dermatitis. Patients will have a photo taken of their atopic dermatitis for photographic evaluation by a dermatologist.

Risk/discomfort: No risk or discomfort are associated with this.

6. SAFETY REPORTING AND MEDICAL MANAGEMENT 6.1 Definition of adverse events

Definition of adverse events (AE) and severe adverse events (SAE) follow the CT-3 (Detailed guidance on the collection verification and presentation of adverse events/reactions arising from clinical trials on medicinal products for human use) by the European Commission:

6.1.1 Adverse Event (AE) "Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment"

6.1.2 Serious Adverse Event (SAE) "Any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect".

6.1.3 Suspected Unexpected Serious Adverse Reaction (SUSAR): The sponsor/investigator will be responsible for reporting all Suspected Unexpected Serious Adverse Reactions (SUSAR) to relevant authorities including the Danish Medicines Agency, the Committee on Health Research Ethics and ALK-Abello A/S. Fatal and life-threatening events will be reported within 7 days whereas other serious events will be reported within 15 days. The product summary for Acarizax will be used as reference document in the evaluation of SUSARs.

6.2 Recording of adverse events

6.2.1 Time period for collection of adverse events Adverse Events will be collected at every visit throughout the study.

6.2.2 Follow-up of unresolved adverse events AE/SAE's that in the opinion of the investigator may be related to the study drug will be followed as long as medically indicated.

6.2.3 Variables The following variables will be collected for each AE;

- AE (verbatim)

- Date when the AE started and stopped

- Whether the AE is serious or not

- Investigator causality rating against the Investigational Product (yes or no)

- Action taken with regard to investigational product

- If AE caused subject's withdrawal from study (yes or no)

- Outcome.

In addition, the following variables should be collected for SAEs:

- Date AE met criteria for serious AE

- Date Investigator became aware of serious AE

- AE is serious due to...

- Date of hospitalisation

- Date of discharge

- Probable cause of death

- Date of death

- Autopsy performed

- Causality assessment in relation to Study procedure(s)

- Description of AE.

6.2.4 Causality assessment The investigator will classify the AE/SAE as either

1. Reasonable possibility of a relatedness or

2. No reasonable possibility of relatedness. The decision will be based on facts, evidence or arguments to suggest a causal relationship. Time relationship (between study drug administration and event), mechanism of action of Acarizax, medical history, class effects, concomitant medication, etc. will be taken into consideration. The product summary for Acarizax and Placebo will be used as reference document in the evaluation of SUSARs.

6.3 Reporting of serious adverse events According to regulations by the Danish Medicines Agency, a list of all SAE including safety status of participants will be reported to the Danish Medicines Agency and the Committee on Health Research Ethics once a year. SAEs will be reported to ALK-Abello A/S at the time they are reported to any health authority, and at least with three-month intervals. All AEs are reported as part of the final study report. SUSARS will be reported as described in section 6.1.3.

6.4 Overdose In case of overdose (or suspected overdose), the subject will be thoroughly evaluated by the investigator, and, if necessary, monitored for as long as needed (as judged by the investigator).

6.5 Pregnancy In case of pregnancy the patient will immediately be withdrawn from the study, and AEs will, if possible, be collected throughout the pregnancy, including registering pregnancy outcome.

6.6 Study governance and oversight

6.6.1 Study Site Bispebjerg Hospital, Dep. of Respiratory Medicine Bispebjerg Bakke 23, Entrance 66 DK - 2400 Copenhagen NV Denmark Phone: (+45) 35 31 35 69 Fax: (+45) 35 31 21 79

6.6.12 Additional sites of analyses

- Department of Immunology and Microbiology, University of Copenhagen

- Department of Respiratory Immunopharmacology University of Lund

- ALK-Abelló A/S, Boege Allé 6-8, 2970 Hoersholm

6.6.13 Study registration and authorities Study code: VITAL EudraCT: 2019-003261-18 Ethics Committee journal number: H-19052148 Danish Medicines Agency: pending

ClinicalTrial.gov:

6.6.14 Steering Committee Christian Uggerhoej Woehlk, M.D., Ph.D.-student Asger Sverrild, M.D., Ph.D. Charlotte Menné Bonefeld, Professor Lena Uller Ass. Professor Steen Roenborg, M.D. Ph.D. Celeste Porsbjerg, Professor, M.D.

6.6.15 Participants and collaborators

1. Pharmacy: Region Hovedstadens Apotek, Marielundvej 25, 2730 Herlev, Denmark.

2. Peter Arvidsson, M.D., PhD.: ALK-Abelló Nordic A/S, Kungbacke Sweden

3. Peter Sejer Andersen: ALK-Abelló A/S, Boege Allé 6-8, Bygn. 9, 2970 Hoersholm

4. Peter Adler Würtzen, Senior Specialist, PhD: ALK-Abelló A/S, Boege Allé 6-8, Bygn. 9, 2970 Hoersholm

8. STATISTICAL ANALYSES 8.1 Sample size estimate Sample size calculations have been carried out using G-Power software (Behaviour Research Methods 2007 Faul et al).

8.1.1 Primary outcome:

To our knowledge there is no preceding studies investigation the relationship between AIT treatment and change in IFN-response in HBECS. We have previously shown that treating human airway epithelium in vitro with azithromycin increase the IFN-response to viral infection mimics in a dose-dependent manner. Fold-change in INF-β was 1.55 (SD 0.555) at the given concentration. Given a significant change in IFN-β from week 0 to week 24 is set to be a 1.55-fold change with SD of 0.555, that alpha is set to 0.05, and the power to 0.80, in a two-sided test design, the calculation would look like this:

Mean (fold change in INF-β) group 1 (placebo): 1 Mean (fold change in INF-β) group 2 (Acarizax): 1.55 SD: 0.55 16 subjects will be needed in each study arm. Assuming a drop-out of 20%, a minimum of 40 subjects in total will need to be randomized.

8.2 Definitions of analysis sets

1) Populations for analysis:

1. Intention-to-treat population: All randomized subjects who receive at least one dose of Acarizax or placebo. A comparison of the treatment groups will be performed.

2) Population for analysis based on adherence ≥ 80% to treatment.

1. Intention-to-treat population: All randomized subjects with adherence ≥ 80% to Acarizax therapy or placebo. A comparison of the treatment groups will be performed.

8.2.1 Efficacy analysis set Intention-to-treat population (as defined in 8.2).

8.2.2 Safety analysis set All patients who receive at least one dose of Acarizax/placebo.

8.3 Methods for statistical analyses All data limited to primary and key secondary outcomes will be analysed using SPSS v. 14 or later. all data are reported as median values with interquartile ranges and were analysed using non-parametric tests. Data within each group (Acarizax and placebo) will be analysed using linear mixed model or ANCOVA. Statistical differences between the Acarizax and placebo groups will be determined using the Mann - Whitney U test for unrelated samples. Skewed-data will be log-transformed before analysis and reported using median and 25/75 % percentiles. Parametric data will be analysed using the above-mentioned methods. Categorial data will be analysed using χ²-test. Statistical significance is defined as p<0.05. The data from the subject dropping out will still be used in the analysis using methods for handling of missing data.

8.3.1 Analysis of the primary variable(s) The fold-change in IFN-β and IFN-λ are analysed before and after RV infection and/or poly(I:C) stimulation from V2 to V7 and will be compared between intervention and placebo treatment. We expect parametric distribution of data.

The calculation will be as follows:

1. deltaIFN-β: IFN-β V7 - IFN-βV2

2. Mean fold-change IFN-β: Sum of individual changes / N

Supportive primary objectives are calculated between intervention and placebo treatment groups:

1. Change in expression of IFN-λ measured in ρg/ml (ELISA) and reported as fold change mean ± SD

2. Change in viral load/TCID50 assay measure reported as fold change mean ± SD

8.3.2 Analysis of the secondary variable(s)

- Changes in IFN-responses will be analysed using same procedure as analysis of the primary outcome.

- Cytokines will be analysed accordingly to the method described in 8.3.1 and reported as ρm/ml (or similar quantitative method) and reported as fold change mean ± SEM

- Change in IFN-β/TSLP ratio and reported in %.

- The change, expressed as a ratio, in number of airway submucosal, muscle and epithelium mast cells, eosinophils, neutrophils, NK-cells, (MCT, MCTC and MCCPA3) per mm2 determined by microscopic evaluation of mucosa biopsies and epithelial brushings from V2 to V7.

8.3.3 Interim analysis No interim analysis is planned.

8.3.4 Use of database REDCap will be used for online CRF data management.

9. STUDY AND DATAMANGEMENT 9.1 Economy

The scientific ideas of protocol are based solely on the work of members of the steering committee. None of the members of the steering committee have any commercial interest in the results of this study. As per 01.08.19, the project has received:

1. Unrestricted grant from ALK-Abelló Nordic of (900.000dkk)

2. Unrestricted grant from Sawmill owner Jeppe Juhl and wife Ovita Juhls memorial fund (250.000 dkk).

9.2. Subject reimbursement Each subject completing the study will receive a total of 6 months of Acarizax treatment equivalent to approximate 5.500 dkk. Subject randomized to Acarizax arm will not be furtherly compensated.

9.2.1 Source data Will be filed at Bispebjerg Hospital, Denmark (study site) in accordance with The Danish Data Protection Agency laws. Source data will be kept for a maximum of 20 years from (01.09.2019). At this point all source data will be destroyed.

9.2.2 Study agreements All agreements relating to the study will be available in the trial master file (TMF).

9.2.3 Archiving of study documents Documents will be archived at Bispebjerg Hospital, Denmark (study site) in accordance with GCP and The Danish Data Protection Agency laws.

9.3 Monitoring of the study

The study will be monitored by the GCP Unit in Copenhagen:

Copenhagen University Hospital GCP-unit Bispebjerg Hospital, Building 51, 3.fl Bispebjerg Bakke 23 DK - 2400 København NV Denmark Phone: (+45) 3531 3887 E-mail: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk www.gcp-enhed.dk.

Study Design

Conditions

Allergic Asthma Due to Dermatophagoides Pteronyssinus

Intervention

ODACTRA 12 SQ-HDM Sublingual Tablet, Placebo oral tablet

Location

Respiratory Research Unit
Copenhagen
Denmark
2400

Status

Not yet recruiting

Source

Bispebjerg Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-27T06:30:41-0400

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