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    Clinical Trial Results:
    The effects of allergen immunotherapy on anti-viral immunity in patients with allergic asthma

    Summary
    EudraCT number
    		 2019-003261-18
    Trial protocol
    		 DK  
    Global end of trial date
    31 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2023
    First version publication date
    27 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VITAL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04100902
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Respiratory Research Unit, Department of Respiratory Medicine, Bispebjerg University Hospital
    Sponsor organisation address
    Ebba Lunds Vej 48, Entr. 66, Copenhagen NV, Denmark, 2400
    Public contact
    Christian Woehlk, Dept. Respiratory and Infectious Diseases, Bispbjerg Hospital, Respiratory Research Unit, Dept. Respiratory and Infectious Diseases, Bispebjerg Hospital, DK, +45 53644292, cwoe0007@regionh.dk
    Scientific contact
    Christian Woehlk, Dept. Respiratory and Infectious Diseases, Bispbjerg Hospital, Respiratory Research Unit, Dept. Respiratory and Infectious Diseases, Bispebjerg Hospital, DK, +45 53644292, cwoe0007@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of allergen immunotherapy on anti-viral immunity in patients with allergic asthma. Main outcome is to investigate potentiale change in bronchial epithelial cells interferon secretion before and after 6 month of treatment with ACARIZAX or placebo.
    Protection of trial subjects
    Pseudoanonomised
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients recruited via the respiratory outpatient clinic at Bispebjerg Hospital, Copenhagen, Denmark and via social media.

    Pre-assignment
    Screening details
    		 As per investigators judgement

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Since both Acarizax and placebo are relabelled at the central pharmacy according to a randomization code, the investigational product will be received blinded to the study site.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 SQ HDM-SLIT
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ACARIZAX® 12 SQ oral lyophilisate
    Investigational medicinal product code
    Other name
    ODACTRA®, MITICURE (TM)
    Pharmaceutical forms
    Chewable/dispersible tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    12-SQ, QD

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    No active ingredient, QD

    Number of subjects in period 1
    		Active Placebo
    Started
    20
    19
    Completed
    18
    18
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Suspected pregnancy
    -
    1
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 SQ HDM-SLIT

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 20 19 39
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 19 39
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28 ( 7.3 ) 28 ( 8.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 12 25
        Male
    		 7 7 14
    FEV1
    L/s
    Units: L/s
        arithmetic mean (standard deviation)
    		 3.6 ( 0.82 ) 3.7 ( 0.71 ) -
    FEV1/FVC
    Units: ratio
        arithmetic mean (standard deviation)
    		 0.77 ( .078 ) 80 ( .077 ) -
    FEV1 pct
    Units: procentage
        arithmetic mean (standard deviation)
    		 90 ( 13 ) 95 ( 12 ) -

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 SQ HDM-SLIT

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Delta IFN-B mRNA rel. to UBC/GADPH

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    End point title
    		 Delta IFN-B mRNA rel. to UBC/GADPH
    End point description
    Delta IFN-B is calculated within groups from baseline to week-24 (follow-up)
    End point type
    Primary
    End point timeframe
    Baseline and Week-24
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    17
    Units: IFN-B mRNA rel. to UBC/GADPH
        arithmetic mean (standard deviation)
    1.50 ( 2.84 )
    1.11 ( 2.16 )
    Attachments
    		 Untitled (Filename: Eudract IFN.png)
    Statistical analysis title
    		 Delta IFN-B mRNA expression rel to UBC/GADPH
    Statistical analysis description
    Total RNA was extracted from HBECs using a RNeasy Plus Mini Kit (Qiagen) and 1 μg of RNA was reverse transcribed to cDNA (High-Capacity cDNA Reverse Transcription Kit, applied biosystems, Thermo Fisher Scientific). Amplification was performed by AriaMX realtime PCR system (Agilent Technologies, Glostrup, Denmark) as previously described. Target genes are listed in the Online Supplementary. The -ΔΔCt method was then applied for relative quantification using UBC/GAPDH as housekeeping genes
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.41
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Full study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 RedCap
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 SQ HDM-SLIT

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 19 (5.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Angioedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleuritis
    Additional description: Pleuritis following bronchoscopy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Pyelonephritis acute
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 20 (40.00%)
    8 / 19 (42.11%)
    General disorders and administration site conditions
    Throat irritation
         subjects affected / exposed
    8 / 20 (40.00%)
    6 / 19 (31.58%)
         occurrences all number
    17
    17
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 20 (25.00%)
    6 / 19 (31.58%)
         occurrences all number
    17
    17
    Infections and infestations
    Fever
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 19 (10.53%)
         occurrences all number
    17
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jun 2020
    Amendment v.2.2. Deletion of exclusion criteria: Birch sensitisation Change GINA 3-5 to 2-4 Add inclusion criteria Dose of ICS budesonide equivalent ≥400 μg Change inclusion criteria: Moderate to severe rhinitis to HDM induced mild-severe allergic rhinitis for at least 1 year

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36701676
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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