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    Clinical Trial Results:
    A Randomised, Double-blind, Single-centre, Controlled Trial of Low Dose Intradermal Allergen Immunotherapy in Adults with Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2012-002193-31
    Trial protocol
    		 GB  
    Global end of trial date
    27 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Oct 2018
    First version publication date
    13 Oct 2018
    Other versions
    Summary report(s)
    		 STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    PollenLITE
    Additional study identifiers
    ISRCTN number
    		 ISRCTN78413121
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Dr Stephen Till, King's College London, +44 02071880599, stephen.till@kcl.ac.uk
    Scientific contact
    Dr Stephen Till, King's College London, +44 02071880599, stephen.till@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Stephen Till, Guy's and St Thomas' NHS Foundation Trust, +44 02071880599, stephen.till@kcl.ac.uk
    Scientific contact
    Dr Stephen Till, Guy's and St Thomas' NHS Foundation Trust, +44 02071880599, stephen.till@kcl.ac.uk
    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
    27 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to determine if pre-seasonal low dose intradermal grass pollen allergen immunotherapy (either 7 or 8 two-weekly injections of 10 Biological Units (33.333 SQ-U)) reduces symptoms and requirements for anti-allergic drugs in seasonal allergic rhinitis during the 2013 grass pollen season compared to the control intervention (histamine only).
    Protection of trial subjects
    Paricipants were followed-up at 4 months and randomised for follow-up at either 7, 10 or 13 months following final vaccine for open label intradermal skin tests with grass pollen (10 BU)
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 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
    United Kingdom: 93
    Worldwide total number of subjects
    93
    EEA total number of subjects
    93
    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)
    93
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Ninety-three participants allergic to grass pollen were enrolled and randomised to receive the first intradermal injection of grass pollen or histamine control between February 18 and March 1 of 2013

    Pre-assignment
    Screening details
    		 Inclusion Criteria 1) Adults aged 18 to 65 years. 2) A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July. 3) A clinical history of moderate-severe persistent rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep.

    Pre-assignment period milestones
    Number of subjects started
    		 93
    Number of subjects completed
    		 93

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ACTIVE
    Arm description
    		 The active drug will be 1 O Biological Units (BU) (33.333 SQ-U) of Ph/eum pretense soluble grass pollen extract (Aquagen SQ Timothy, ALK Abello) contained in a 20 microlitre volume (i.e. 500 BU/ml (1666.666 SQ-U/ml)).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aquagen SQ Timothy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A series of 7 intradermal active or control injections will be administered 2-weekly into the forearm between before the 2013 grass pollen season. 1 O Biological Units at each injection

    Arm title
    		 CONTROL GROUP
    Arm description
    		 Control will be histamine only, administered at a concentration of 100 mcg/ml (histamine dose validated by Sherer et al., Clin Exp Allergy. 2007;37:39-46). To help preserve blinding, histamine concentrations·will be reduced to 30 mcg/ml for the 3rd and 4th injections, and 10 mcg/ml for 5, 6 and ?1h injections. To match the grass pollen extract dilution and preserve blinding, histamine will also be aliquoted into study vials at 60-times final working strength in 0.15 ml volumes, for further dilution with 8.85 ml of clinical grade 0.9% normal saline immediately prior to injection.
    Arm type
    		 CONTROL

    Investigational medicinal product name
    HISTAMINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    A series of 7 intradermal active or control injections will be administered 2-weekly into the forearm between before the 2013 grass pollen season. The first injection will be administered between 18th February and 1st March 2013. We will aim to administer the 7th injection between 13th May and 24th May 2013. The injection site will again be alternated between left and right arms at each visit. lntradermal injections will be administered in a 20 microlitre volume using a 29 gauge insulin syringe (Becton Dickinson Micro-FineTM).

    Number of subjects in period 1
    		ACTIVE CONTROL GROUP
    Started
    46
    47
    Completed
    46
    46
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole Group
    Reporting group description
    		 -

    Reporting group values
    		 Whole Group Total
    Number of subjects
    		 93 93
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 93 93
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 31 31
        Male
    		 62 62

    End points

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    End points reporting groups
    Reporting group title
    ACTIVE
    Reporting group description
    		 The active drug will be 1 O Biological Units (BU) (33.333 SQ-U) of Ph/eum pretense soluble grass pollen extract (Aquagen SQ Timothy, ALK Abello) contained in a 20 microlitre volume (i.e. 500 BU/ml (1666.666 SQ-U/ml)).

    Reporting group title
    CONTROL GROUP
    Reporting group description
    		 Control will be histamine only, administered at a concentration of 100 mcg/ml (histamine dose validated by Sherer et al., Clin Exp Allergy. 2007;37:39-46). To help preserve blinding, histamine concentrations·will be reduced to 30 mcg/ml for the 3rd and 4th injections, and 10 mcg/ml for 5, 6 and ?1h injections. To match the grass pollen extract dilution and preserve blinding, histamine will also be aliquoted into study vials at 60-times final working strength in 0.15 ml volumes, for further dilution with 8.85 ml of clinical grade 0.9% normal saline immediately prior to injection.

    Primary: A combined symptom and medication score during the grass pollen season period of mid May-August 2013.

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    End point title
    		 A combined symptom and medication score during the grass pollen season period of mid May-August 2013. [1]
    End point description
    daily combined symptom and medication scores according to treatment group over the 2013 grass pollen season
    End point type
    Primary
    End point timeframe
    During grass pollen season between mid May-August 2013.
    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: See attached study report for full analysis
    End point values
    		 ACTIVE CONTROL GROUP
    Number of subjects analysed
    46
    46
    Units: score
        number (not applicable)
    46
    46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout whole trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ACTIVE
    Reporting group description
    		 The active drug will be 1 O Biological Units (BU) (33.333 SQ-U) of Ph/eum pretense soluble grass pollen extract (Aquagen SQ Timothy, ALK Abello) contained in a 20 microlitre volume (i.e. 500 BU/ml (1666.666 SQ-U/ml)).

    Reporting group title
    CONTROL GROUP
    Reporting group description
    		 Control will be histamine only, administered at a concentration of 100 mcg/ml (histamine dose validated by Sherer et al., Clin Exp Allergy. 2007;37:39-46). To help preserve blinding, histamine concentrations·will be reduced to 30 mcg/ml for the 3rd and 4th injections, and 10 mcg/ml for 5, 6 and ?1h injections. To match the grass pollen extract dilution and preserve blinding, histamine will also be aliquoted into study vials at 60-times final working strength in 0.15 ml volumes, for further dilution with 8.85 ml of clinical grade 0.9% normal saline immediately prior to injection.

    Serious adverse events
    		 ACTIVE CONTROL GROUP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ACTIVE CONTROL GROUP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 46 (6.52%)
    6 / 47 (12.77%)
    Immune system disorders
    pruritus without wheals
         subjects affected / exposed
    2 / 46 (4.35%)
    6 / 47 (12.77%)
         occurrences all number
    2
    6
    Erythema
    Additional description: Erythema that tracked from the injection site in a lymphatic distribution (‘IgE-mediated lymphangitis’) approximately 20 minutes after each administration.
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2013
    Four additional secondary endpoints have been added and the statistical analysis section has been re-worded for clarification. The changes are being made following the finalisation of the statistical analysis plan by the statistician and before the collection of primary outcome data is commenced.

    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/27977090
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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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