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    Clinical Trial Results:
    Characterization of human peripheral and intestinal T-cell responses after mucosal antigen exposure: induction of tolerance vs. immunization by oral administration of KLH

    Summary
    EudraCT number
    		 2011-001232-27
    Trial protocol
    		 DE  
    Global end of trial date
    30 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Feb 2020
    First version publication date
    28 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KLEX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Dr. Reiner Ullrich, CBF, Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, reiner.ullrich@charite.de
    Scientific contact
    Dr. Reiner Ullrich, CBF, Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, reiner.ullrich@charite.de
    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
    30 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety of immunization with KLH following oral and / or parenteral administration
    Protection of trial subjects
    Treated at tertiary care center
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2012
    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
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: June 26, 2012 to June 4, 2014

    Pre-assignment
    Screening details
    		 healthy volunteers including normal blood count, CRP, ALT, GGT, creatinin

    Period 1
    Period 1 title
    Exposition (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 oral-parenteral (A1)
    Arm description
    		 The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Keyhole limpet hemocyanin (KLH)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/skin-prick test, Oral solution
    Routes of administration
    Cutaneous use, Oral use
    Dosage and administration details
    The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Arm title
    		 control K1
    Arm description
    		 The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Keyhole limpet hemocyanin (KLH)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Arm title
    		 parenteral-oral-parenteral (A2)
    Arm description
    		 To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Keyhole limpet hemocyanin (KLH)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection/skin-prick test
    Routes of administration
    Cutaneous use, Oral use
    Dosage and administration details
    To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Arm title
    		 control K2
    Arm description
    		 To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Keyhole limpet hemocyanin (KLH)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/skin-prick test
    Routes of administration
    Cutaneous use
    Dosage and administration details
    To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Number of subjects in period 1
    		oral-parenteral (A1) control K1 parenteral-oral-parenteral (A2) control K2
    Started
    8
    8
    2
    4
    Completed
    8
    8
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Exposition
    Reporting group description
    		 -

    Reporting group values
    		 Exposition Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        Adults (18-69)
    		 22 22
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    oral-parenteral (A1)
    Reporting group description
    		 The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Reporting group title
    control K1
    Reporting group description
    		 The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Reporting group title
    parenteral-oral-parenteral (A2)
    Reporting group description
    		 To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Reporting group title
    control K2
    Reporting group description
    		 To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Primary: Number of SAR

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    End point title
    		 Number of SAR
    End point description
    End point type
    Primary
    End point timeframe
    Trial duration
    End point values
    		 oral-parenteral (A1) control K1 parenteral-oral-parenteral (A2) control K2
    Number of subjects analysed
    8
    8
    2
    4
    Units: Number of SAR
    0
    0
    0
    0
    Statistical analysis title
    		 Safety of oral KLH
    Statistical analysis description
    The frequency of SAR will be compared between oral (A1, A2) and parenteral only (K1, K2) groups by the two-tailed Chi-Square test.
    Comparison groups
    oral-parenteral (A1) v control K1 v parenteral-oral-parenteral (A2) v control K2
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Trial duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    oral-parenteral (A1)
    Reporting group description
    		 The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Reporting group title
    control K1
    Reporting group description
    		 The subjects of the oral group A1 receive daily 50 mg KLH orally for ten days, followed by two parenteral immunizations with 0.1 mg KLH subcutaneously The subjects of the control group K1 receive only the parenteral immunizations. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Reporting group title
    parenteral-oral-parenteral (A2)
    Reporting group description
    		 To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Reporting group title
    control K2
    Reporting group description
    		 To test whether oral KLH can modulate existing KLH-specific immunity, subjects of groups A2 and K2 are first immunized by two parenteral immunizations with 0.1 mg KLH subcutaneously. A skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally. The A2 subjects but not the K2 subjects then receive daily 50 mg KLH orally for ten days. Ten days later in both groups a skin delayed-type hypersensitivity reaction is elicited by 0.01 mg KLH intradermally.

    Serious adverse events
    		 oral-parenteral (A1) control K1 parenteral-oral-parenteral (A2) control K2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 oral-parenteral (A1) control K1 parenteral-oral-parenteral (A2) control K2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    7 / 8 (87.50%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
    General disorders and administration site conditions
    skin reaction
    Additional description: Skin reaction: patients developed a typical local delayed-type hypersensitivity reaction at the injection site after intradermal application of KLH. This reaction was expected and well-tolerated. No systemic allergic reaction was observed.
         subjects affected / exposed
    2 / 8 (25.00%)
    7 / 8 (87.50%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
         occurrences all number
    2
    7
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2013
    a) non-substantial changes of the protocol (The protocol refers now to the reference values of the Charité Laboratory) b) Amendment with respect to the IMPD (shelf life extension of the IMP)

    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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