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    Clinical Trial Results:
    Intratumoral Influenza Vaccine for Early Colorectal Cancer

    Summary
    EudraCT number
    		 2020-000725-27
    Trial protocol
    		 DK  
    Global end of trial date
    01 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2023
    First version publication date
    28 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2020-000725-27
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    LYkkebækvej 1, Køge, Denmark,
    Public contact
    Research fellow, Center for Surgical Science, Department of Surgery, Zealand University Hospital, 0045 31429929, mgog@regionsjaelland.dk
    Scientific contact
    Research fellow, Center for Surgical Science, Department of Surgery, Zealand University Hospital, 0045 31429929, mgog@regionsjaelland.dk
    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
    01 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary: To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.
    Protection of trial subjects
    Treated in routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2021
    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
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    2
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited after the colorectal cancer MDT conference

    Pre-assignment
    Screening details
    		 Patients were screened at the colorectal cancer MDT conference

    Period 1
    Period 1 title
    Full study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a non-blinded single arm study

    Arms
    Arm title
    		 Active
    Arm description
    		 Treatment with intratumoral influenza vaccine
    Arm type
    		 Experimental

    Investigational medicinal product name
    InfluVacTetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intratumoral use
    Dosage and administration details
    A single dose influenza vaccine (50 microliter) that was mixed with 150 microliter saline

    Number of subjects in period 1
    		Active
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full study
    Reporting group description
    		 -

    Reporting group values
    		 Full study Total
    Number of subjects
    		 10 10
    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)
    		 2 2
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline characteristics Tumor-infiltrating lymphocytes mRNA gene expression Spatial protein expression FLOW analysis of blood

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    10
    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)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    2
        From 65-84 years
    8
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    7

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Treatment with intratumoral influenza vaccine

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline characteristics Tumor-infiltrating lymphocytes mRNA gene expression Spatial protein expression FLOW analysis of blood

    Primary: Safety of treatment (CTCAE v4)

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    End point title
    		 Safety of treatment (CTCAE v4)
    End point description
    End point type
    Primary
    End point timeframe
    Day 0-14
    End point values
    		 Active Full analysis
    Number of subjects analysed
    10
    10
    Units: Events
        Adverse events
    1
    1
        Serious adverse events
    0
    0
    Statistical analysis title
    		 Confidence interval for adverse events
    Comparison groups
    Active v Full analysis
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Confidence interval
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 30
    Notes
    [1] - The investigators performed af statistical analysis of the confidence interval for adverse events as specified in "Simon, S. Confidence interval with zero events. http://new.pmean.com/zero-events/ (2001)"

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0-14
    Adverse event reporting additional description
    CTCAE v4
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    General disorders and administration site conditions
    Fever
    Additional description: A mild fever that subsided without intervention
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    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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