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    Clinical Trial Results:
    The effect of tetanus revaccination in patients with myasthenia gravis

    Summary
    EudraCT number
    		 2014-004344-35
    Trial protocol
    		 NL  
    Global end of trial date
    16 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jan 2022
    First version publication date
    15 Jan 2022
    Other versions
    Summary report(s)
    		 Tetanus

    Trial information

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    Trial identification
    Sponsor protocol code
    50993
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LUMC
    Sponsor organisation address
    Albinusdreef 2, Leiden, Netherlands, 2333ZA
    Public contact
    Tetanus study contact, Leiden University Medical Center, 0031 715262118, myasthenie@lumc.nl
    Scientific contact
    Tetanus study contact, Leiden University Medical Center, 0031 715262118, myasthenie@lumc.nl
    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 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effectiveness of the humeral and cellular immune response after tetanus revaccination in patients with AChR MG, MuSK MG, or LEMS.
    Protection of trial subjects
    Vital signs were measured directly after the revaccination and before leaving the hospital.
    Background therapy
    		 Mestinon Prednisolone Azathioprine Mycofenolate mofetil Ciclosporine
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2014
    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
    Netherlands: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    61
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were asked to consider participation in the longitudinal experimental study by their treating physician at the LUMC and/or through the patient organisation “Spierziekten Nederland”.

    Pre-assignment
    Screening details
    		 1. Males and females aged between 18 years and 65 years at the time of the injection. 2. Patient with ocular or generalized AChR MG, MuSK MG or LEMS; and 3. A positive serologic test for AChR antibodies > 0.5 nmol/l or MuSK antibodies >0.1 nmol/l or VGCC antibodies >20 fmol/l. 4. Patient with prednisone dose lower than 30mg and stable (dose +/

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Tetanus vaccin in patients
    Arm description
    		 All patients in the study received tetanus
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tetanus vaccine
    Investigational medicinal product code
    17639
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose of 0.5ml contains 40 IU tetanus toxoid (TT), 1.5 mg aluminium phosphate and 0.05 mg thimerosal

    Number of subjects in period 1
    		Tetanus vaccin in patients
    Started
    65
    Completed
    65

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tetanus vaccin in patients
    Reporting group description
    		 All patients in the study received tetanus

    Reporting group values
    		 Tetanus vaccin in patients Total
    Number of subjects
    		 65 65
    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)
    		 61 61
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 55 (21 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 46 46
        Male
    		 19 19
    Subject analysis sets

    Subject analysis set title
    AChR
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AChR MG patients

    Subject analysis set title
    MuSK MG
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with MuSK MG

    Subject analysis set title
    LEMS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with LEMS

    Subject analysis set title
    HC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Healthy controls

    Subject analysis set title
    AChR Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AChR MG patienten met placebo (saline)

    Subject analysis sets values
    		 AChR MuSK MG LEMS HC AChR Placebo
    Number of subjects
    50
    6
    9
    20
    23
    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)
    46
    6
    9
        From 65-84 years
    4
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    56 (21 to 65)
    44.5 (21 to 65)
    49.3 (21 to 65)
    Gender categorical
    Units: Subjects
        Female
    37
    3
    6
        Male
    13
    3
    3

    End points

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    End points reporting groups
    Reporting group title
    Tetanus vaccin in patients
    Reporting group description
    		 All patients in the study received tetanus

    Subject analysis set title
    AChR
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AChR MG patients

    Subject analysis set title
    MuSK MG
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with MuSK MG

    Subject analysis set title
    LEMS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with LEMS

    Subject analysis set title
    HC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Healthy controls

    Subject analysis set title
    AChR Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AChR MG patienten met placebo (saline)

    Primary: MG Composite

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    End point title
    		 MG Composite
    End point description
    End point type
    Primary
    End point timeframe
    Before vaccination and 4 weeks after vaccination
    End point values
    		 AChR AChR Placebo
    Number of subjects analysed
    50
    23
    Units: 50
    5
    6
    Attachments
    		 Clinical scores
    Statistical analysis title
    		 MG composite pre and post
    Comparison groups
    AChR Placebo v AChR
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 paired t-test
    Confidence interval

    Primary: Tetanus IgG titer

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    End point title
    		 Tetanus IgG titer
    End point description
    End point type
    Primary
    End point timeframe
    Before and 4 weeks after vaccination
    End point values
    		 AChR HC
    Number of subjects analysed
    50
    20
    Units: microgram(s)/litre
        geometric mean (confidence interval 95%)
    34.04 (22.2 to 52.1)
    77.2 (54.2 to 110.2)
    Attachments
    		 IgG pre and post
    Statistical analysis title
    		 IgG post
    Statistical analysis description
    Comparison of IgG total post vaccination between HC and ACHR MG
    Comparison groups
    AChR v HC
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 unpaired t-test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Untill 3 months after revaccination
    Adverse event reporting additional description
    Swelling and redness at injection site
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    x
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 65 (72.31%)
    Skin and subcutaneous tissue disorders
    Pain of skin
    Additional description: Swelling and redness at injection site
         subjects affected / exposed
    47 / 65 (72.31%)
         occurrences all number
    47

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28992975
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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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