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    Clinical Trial Results:
    Preventive sublingual immunotherapy for house dust mite sensitized preschool children

    Summary
    EudraCT number
    		 2016-002844-18
    Trial protocol
    		 AT  
    Global end of trial date
    16 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    04071962
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Zsolt Szepfalusi, PI, Dpt. of Pediatrics, Div. of Ped Pneumology, Allergy and Endocrinology, Medical University of Vienna, 0043 14040012320, zsolt.szepfalusi@meduniwien.ac.at
    Scientific contact
    Zsolt Szepfalusi, PI, Dpt. of Pediatrics, Div. of Ped Pneumology, Allergy and Endocrinology, Medical University of Vienna, 0043 14040012320, zsolt.szepfalusi@meduniwien.ac.at
    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
    16 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To induce protective immunomodulation (increase of allergen-specific IgG, IgG4, TGFb, IL10) in children with IgE-sensitization to house dust mite without allergic disease manifestation at the age of 4 years
    Protection of trial subjects
    children at age 4 years with house dust mite IgE-sensitization without allergic disease manifestation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    37
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Children four years of age with sensitization to house dust mite (SPT > 3mm or specific IgE > 0.35 kU/l) without clinical history of allergic symptoms are eligible for study participation: Signed informed consent, additional sensitization to max 3 other allergens, optionally atopic dermatitis with topic steroid treatment, virus preschool wheeze

    Pre-assignment
    Screening details
    		 2865 HDM-sensitized children were identified; 72 of these were at preschool age (3-5 years) and were contacted. From 39 consenting participants, 37 eligible children were included who were sensitized to HDM but had no allergy symptoms.

    Period 1
    Period 1 title
    active phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 active phase
    Arm description
    		 Using computerized 2:2 block randomization, eligible children were assigned to HDM-SLIT (Staloral®; dose: 300 index of reactivity (IR)/day) or placebo (Stallergenes-Greer, France) for 2 years (eMethod 1). Clinical assessments and blood sampling were performed at 0 month (baseline), 4-, 12-, and 24-months (end of treatment (EOT)).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Staloral
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual solution
    Routes of administration
    Sublingual use
    Dosage and administration details
    300IR units per day over 2 years

    Arm title
    		 Placebo
    Arm description
    		 Using computerized 2:2 block randomization, eligible children were assigned to HDM-SLIT (Staloral®; dose: 300 index of reactivity (IR)/day) or placebo (Stallergenes-Greer, France) for 2 years (eMethod 1). Clinical assessments and blood sampling were performed at 0 month (baseline), 4-, 12-, and 24-months (end of treatment (EOT)).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual solution
    Routes of administration
    Sublingual use
    Dosage and administration details
    300IR units per day for 2 years

    Number of subjects in period 1
    		active phase Placebo
    Started
    20
    17
    Completed
    18
    15
    Not completed
    2
    2
         Consent withdrawn by subject
    2
    1
         left the country
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    active phase
    Reporting group description
    		 Using computerized 2:2 block randomization, eligible children were assigned to HDM-SLIT (Staloral®; dose: 300 index of reactivity (IR)/day) or placebo (Stallergenes-Greer, France) for 2 years (eMethod 1). Clinical assessments and blood sampling were performed at 0 month (baseline), 4-, 12-, and 24-months (end of treatment (EOT)).

    Reporting group title
    Placebo
    Reporting group description
    		 Using computerized 2:2 block randomization, eligible children were assigned to HDM-SLIT (Staloral®; dose: 300 index of reactivity (IR)/day) or placebo (Stallergenes-Greer, France) for 2 years (eMethod 1). Clinical assessments and blood sampling were performed at 0 month (baseline), 4-, 12-, and 24-months (end of treatment (EOT)).

    Reporting group values
    		 active phase Placebo Total
    Number of subjects
    		 20 17 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 20 17 37
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 10 20
        Male
    		 10 7 17
    Subject analysis sets

    Subject analysis set title
    Induction of HDM- slgG in active treated group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary and most secondary parameters were compared using either median or linear regression models, depending on the data skewness. Regressions models compared the time course of each value between randomized groups accounting for group, time, the interaction between time and group as fixed and subject identification number as random factor.

    Subject analysis sets values
    		 Induction of HDM- slgG in active treated group
    Number of subjects
    37
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    37
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    20
        Male
    17

    End points

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    End points reporting groups
    Reporting group title
    active phase
    Reporting group description
    		 Using computerized 2:2 block randomization, eligible children were assigned to HDM-SLIT (Staloral®; dose: 300 index of reactivity (IR)/day) or placebo (Stallergenes-Greer, France) for 2 years (eMethod 1). Clinical assessments and blood sampling were performed at 0 month (baseline), 4-, 12-, and 24-months (end of treatment (EOT)).

    Reporting group title
    Placebo
    Reporting group description
    		 Using computerized 2:2 block randomization, eligible children were assigned to HDM-SLIT (Staloral®; dose: 300 index of reactivity (IR)/day) or placebo (Stallergenes-Greer, France) for 2 years (eMethod 1). Clinical assessments and blood sampling were performed at 0 month (baseline), 4-, 12-, and 24-months (end of treatment (EOT)).

    Subject analysis set title
    Induction of HDM- slgG in active treated group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary and most secondary parameters were compared using either median or linear regression models, depending on the data skewness. Regressions models compared the time course of each value between randomized groups accounting for group, time, the interaction between time and group as fixed and subject identification number as random factor.

    Primary: End of treatment: 2 years treatment

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    End point title
    		 End of treatment: 2 years treatment
    End point description
    Primary objective of the study was to compare the change in Der p 1-sIgG from baseline to EOT by HDM-SLIT versus placebo. Secondary objectives involved assessing between- and within-group differences in the changes of i) sIgG, sIgG1, and/or sIgG4 levels for additional major HDM allergens (Der p 2 and 23), HDM-extract, and other non-treatment allergens, ii) sIgE levels for HDM-extracts and individual allergens, iii) HDM-reactivity in skin and basophils, iv) number of sensitizations to allergen-extracts (in serum and skin, combined) and individual allergens (in serum), and v) IgE-blocking functionality of children’s sera.
    End point type
    Primary
    End point timeframe
    Primary objective of the study was to compare the change in Der p 1-sIgG from baseline to EOT by HDM-SLIT versus placebo.
    End point values
    		 active phase Placebo
    Number of subjects analysed
    20
    17
    Units: microgram(s)/millilitre
        median (inter-quartile range (Q1-Q3))
    4.03 (2.82 to 6.66)
    2.34 (0 to 2.7)
    Statistical analysis title
    		 Baseline analysis
    Comparison groups
    active phase v Placebo
    Number of subjects included in analysis
    37
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs occurred in both groups but none of the participants developed a serious AE possibly-related to treatment.
    Adverse event reporting additional description
    Both groups developed Serious AEs unrelated/unassignable to treatment included adenotomy, tonsillotomy, and wheezing-bronchitis episodes requiring hospitalization.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: AEs occurred in both groups but none of the participants developed a serious AE possibly-related to treatment. Both groups developed Serious AEs unrelated/unassignable to treatment included adenotomy, tonsillotomy, and wheezing-bronchitis episodes requiring hospitalization.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    the study has interfered with the Covid19 pandemic; thus recruitment was hampered
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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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