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    Clinical Trial Results:
    The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitis

    Summary
    EudraCT number
    		 2012-004194-12
    Trial protocol
    		 AT  
    Global end of trial date
    21 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2020
    First version publication date
    04 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CS-BM32-nasal-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienn, Austria, 1090
    Public contact
    HNO Klinik, Medizinische Universität Wien, +43 1404003438, verena.niederberger@meduniwien.ac.at
    Scientific contact
    HNO Klinik, Medizinische Universität Wien, +43 1404003438, verena.niederberger@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
    Interim
    Date of interim/final analysis
    15 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years.
    Protection of trial subjects
    patients were attending the outpatient department for their visits and could contact the primary investigator or the department any time
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Dec 2012
    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
    Austria: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    38
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients participating in the study CS-BM32-003 (EK 1104/2012) were be recruited by personal contact.

    Pre-assignment
    Screening details
    		 Inclusion criteria: • Positive history of grass pollen allergy, positive skin prick test reaction to grass pollen extract, grass pollen allergen-specific IgE and rPhl p 1/rPhl p 5-specific IgE (at least 3.5 kUA/L) at the screening visit of CS-BM32-003 or within 12 months prior to the screening visit of CS-BM32-003

    Period 1
    Period 1 title
    Main study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    Blinding was performed in main study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BM32
    Arm description
    		 BM32
    Arm type
    		 Active comparator

    Investigational medicinal product name
    BM32
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    s.c.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    s.c.

    Number of subjects in period 1
    		BM32 Placebo
    Started
    28
    10
    Completed
    24
    10
    Not completed
    4
    0
         no interest
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BM32
    Reporting group description
    		 BM32

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 BM32 Placebo Total
    Number of subjects
    		 28 10 38
    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)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 28 10 38
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 17 5 22
        Male
    		 11 5 16

    End points

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    End points reporting groups
    Reporting group title
    BM32
    Reporting group description
    		 BM32

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Ig levels in nasal secretions

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    End point title
    		 Ig levels in nasal secretions [1]
    End point description
    End point type
    Primary
    End point timeframe
    Treatment year one: • Visit 1: before the 1st pre-seasonal vaccination • Visit 2: after the 3rd pre-seasonal vaccination • Visit 3: in the middle of the grasspollen season • Visit 4: 2 weeks after the end of the grass pollen sea
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no statistic
    End point values
    		 BM32 Placebo
    Number of subjects analysed
    28 [2]
    10 [3]
    Units: OD
        geometric mean (standard deviation)
    0.0 ± 0.0
    0.0 ± 0.0
    Notes
    [2] - no statistic
    [3] - no statistic
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events are divided into the categories “serious” and “non-serious”. This determines the procedure which must be used to report/document the adverse event
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    n.a.
    Frequency threshold for reporting non-serious adverse events: 2%
    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: no adverse events

    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.
    None reported
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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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