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    Clinical Trial Results:
    COVID-19 : Immune response in patients with cancer undergoing vaccination against SARS-CoV-2

    Summary
    EudraCT number
    		 2021-003710-39
    Trial protocol
    		 BE   PT  
    Global end of trial date
    08 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2025
    First version publication date
    12 Jul 2025
    Other versions
    Summary report(s)
    		 I-SPARC - Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    IJB-COVID-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05075538
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut Jules Bordet
    Sponsor organisation address
    Rue Meylemeersch 90,, Anderlecht, Belgium, 1070
    Public contact
    CTSU, INSTITUT JULES BORDET, cstu.isparc@bordet.be
    Scientific contact
    Institut Jules Bordet, Dr. Evandro de Azambuja, MD, PhD, evandro.deazambuja@hubruxelles.be
    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 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term humoral immune response against SARS-CoV-2 between 3 and 12 months after the last dose (before ICF signature) of an mRNA anti-SARS-CoV-2 vaccine (baseline assessment) 4 cohorts: - Cohort A.1+ A.2: Subjects with active solid malignancies undergoing immunotherapy, endocrine therapy, or targeted agents (alone or in combination, except if with cytotoxic chemotherapy) - Cohort A.3: Subjects with active solid malignancies undergoing cytotoxic chemotherapy +/- any other treatment modality in combination - Cohort B: Subjects with active haematological cancers undergoing systemic treatment - Cohort C: Subjects with malignancy in complete remission, without active cancer treatment for the last year
    Protection of trial subjects
    The protection of subject data and the related rights are guaranteed by the General Data Protection Regulation (European Regulation 2016/679), by the law of 22 August 2002 concerning subject rights in Belgium as well as any new applicable legislation in the participating countries.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    Belgium: 152
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    90
    From 65 to 84 years
    61
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 01/12/2023 and 26/10/2023 subjects with histologically or cytologically confirmed cancer diagnosis were recruited in 1 country (Belgium).

    Pre-assignment
    Screening details
    		 *Subj undergoing active systemic cancer treatment at the time of the last dose of the anti-SARS-CoV-2 mRNA vaccine in non-metastatic/curative setting or metastatic/palliative setting *or subj undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 mo at the time of the last dose of the vaccine

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

    Arms
    Arm title
    		 mRNA vaccination against SARS-CoV-2
    Arm description
    		 anti-SARS-CoV-2 booster dose during the study, as per the national guidelines for vaccination and respecting other local/national recommendations about the ideal timing for vaccination
    Arm type
    		 Other

    Investigational medicinal product name
    Comirnaty/Spikevax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    *0.3 mL (single dose after dilution) *intramuscular (i.m.) administration

    Number of subjects in period 1
    		mRNA vaccination against SARS-CoV-2
    Started
    152
    Completed
    77
    Not completed
    75
         Removed by error
    1
         Consent withdrawn by subject
    8
         Technical problems
    1
         Death
    4
         Study terminated by sponsor
    20
         Lost to follow-up
    6
         Not evaluable
    3
         Protocol deviation
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    mRNA vaccination against SARS-CoV-2
    Reporting group description
    		 anti-SARS-CoV-2 booster dose during the study, as per the national guidelines for vaccination and respecting other local/national recommendations about the ideal timing for vaccination

    Reporting group values
    		 mRNA vaccination against SARS-CoV-2 Total
    Number of subjects
    		 152 152
    Age categorical
    n (Unites : subjects)
    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)
    		 90 90
        From 65-84 years
    		 61 61
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (24 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 124 124
        Male
    		 28 28
    Race
    Units: Subjects
        Asian
    		 2 2
        Black or African American
    		 2 2
        Not reported
    		 1 1
        White
    		 147 147
    ECOG Class at Screening
    Units: Subjects
        Zero
    		 78 78
        One
    		 69 69
        Two
    		 3 3
        Missing
    		 2 2
    ECOG class
    Units: Subjects
        Zero - One
    		 147 147
        Two
    		 3 3
        Missing
    		 2 2
    BMI > 25 m^2/kg
    Units: Subjects
        No
    		 63 63
        Yes
    		 69 69
        Missing
    		 20 20
    Smoking
    Units: Subjects
        Current
    		 24 24
        Former
    		 26 26
        Never
    		 75 75
        Missing
    		 27 27
    ALC class
    Units: Subjects
        <1000
    		 32 32
        >=1000
    		 102 102
        Missing
    		 18 18
    Lymphopenia at baseline
    Units: Subjects
        No
    		 150 150
        Yes
    		 2 2
    Hypogammaglobulinaemia at baseline
    Units: Subjects
        No
    		 151 151
        Yes
    		 1 1
    Hypertension at inclusion
    Units: Subjects
        No
    		 100 100
        Yes
    		 52 52
    Hypercholesterolaemia at inclusion
    Units: Subjects
        No
    		 120 120
        Yes
    		 32 32
    Depression at inclusion
    Units: Subjects
        No
    		 126 126
        Yes
    		 26 26
    Hypothryoidism at inclusion
    Units: Subjects
        No
    		 132 132
        Yes
    		 20 20
    N prior vaccin doses
    Units: Subjects
        Two
    		 25 25
        Three
    		 61 61
        Four
    		 56 56
        Five
    		 10 10
    N months between last vaccination prior inclusion and date inclusion
    Units: Subjects
        < 6 months
    		 79 79
        6 and 9 months
    		 44 44
        >9 months
    		 29 29
    BMI at screening
    Units: m^2/kg
        median (full range (min-max))
    		 25.3 (16.4 to 53.9) -
    ALC at screening
    Units: µl
        median (full range (min-max))
    		 1395.0 (310 to 6100) -
    Subject analysis sets

    Subject analysis set title
    EVALUABLE SUBJECTS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Evaluable subjects: all subjects who received at least two doses of an mRNA anti-SARS-CoV-2 vaccine and from which peripheral blood sample was collected during study

    Subject analysis sets values
    		 EVALUABLE SUBJECTS
    Number of subjects
    115
    Age categorical
    n (Unites : subjects)
    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)
    70
        From 65-84 years
    44
        85 years and over
    1
    Age continuous
    Units: years
        median (full range (min-max))
    61 (24 to 86)
    Gender categorical
    Units: Subjects
        Female
    95
        Male
    20
    Race
    Units: Subjects
        Asian
    2
        Black or African American
    2
        Not reported
    0
        White
    111
    ECOG Class at Screening
    Units: Subjects
        Zero
    63
        One
    48
        Two
    3
        Missing
    1
    ECOG class
    Units: Subjects
        Zero - One
    111
        Two
    3
        Missing
    1
    BMI > 25 m^2/kg
    Units: Subjects
        No
    45
        Yes
    53
        Missing
    17
    Smoking
    Units: Subjects
        Current
    16
        Former
    19
        Never
    62
        Missing
    18
    ALC class
    Units: Subjects
        <1000
    24
        >=1000
    76
        Missing
    15
    Lymphopenia at baseline
    Units: Subjects
        No
    114
        Yes
    1
    Hypogammaglobulinaemia at baseline
    Units: Subjects
        No
    114
        Yes
    1
    Hypertension at inclusion
    Units: Subjects
        No
    82
        Yes
    33
    Hypercholesterolaemia at inclusion
    Units: Subjects
        No
    93
        Yes
    22
    Depression at inclusion
    Units: Subjects
        No
    92
        Yes
    23
    Hypothryoidism at inclusion
    Units: Subjects
        No
    105
        Yes
    10
    N prior vaccin doses
    Units: Subjects
        Two
    24
        Three
    44
        Four
    38
        Five
    9
    N months between last vaccination prior inclusion and date inclusion
    Units: Subjects
        < 6 months
    42
        6 and 9 months
    44
        >9 months
    29
    BMI at screening
    Units: m^2/kg
        median (full range (min-max))
    25.3 (16.9 to 53.9)
    ALC at screening
    Units: µl
        median (full range (min-max))
    1395.0 (440 to 6100)

    End points

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    End points reporting groups
    Reporting group title
    mRNA vaccination against SARS-CoV-2
    Reporting group description
    		 anti-SARS-CoV-2 booster dose during the study, as per the national guidelines for vaccination and respecting other local/national recommendations about the ideal timing for vaccination

    Subject analysis set title
    EVALUABLE SUBJECTS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Evaluable subjects: all subjects who received at least two doses of an mRNA anti-SARS-CoV-2 vaccine and from which peripheral blood sample was collected during study

    Primary: Long-term response rate

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    End point title
    		 Long-term response rate [1]
    End point description
    The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, between 3 and 12 months after the last dose (before ICF signature) of an mRNA anti-SARS-CoV-2 vaccine. 107 evaluable subjects at baseline *) 56 cohort A1+A2 *) 17 cohort A3 *) 9 cohort B *) 25 cohort C The immune response rate was 100% in all subjects, in each cohort, at baseline. • Cohort A1+A2: 56/56 = 100% (95% CI, 94% to 100%). • Cohort A3: 17/17 = 100% (95% CI, 80% to 100%) • Cohort B: 9/9 = 100% (95% CI, 66% to 100%) • Cohort C: 25/25 = 100% (95% CI, 86% to 100%)
    End point type
    Primary
    End point timeframe
    Baseline
    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: Not applicable: single-arm study. The aim was to estimate the immune response rate within each cohort.
    End point values
    		 EVALUABLE SUBJECTS
    Number of subjects analysed
    107 [2]
    Units: Subjects
        Immune response
    107
        No immune response
    0
    Notes
    [2] - Of the 115 subjects, 107 were evaluable at baseline (8 not evaluable)
    No statistical analyses for this end point

    Secondary: Duration of immune response

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    End point title
    		 Duration of immune response
    End point description
    The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, at the final study assessment timepoint, namely at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+ 4 weeks/- 8 weeks) after the first booster dose after ICF signature, if a booster dose of the vaccine is administered during the study per local / national health policy guidelines. Duration of immune response cannot be determined, as no subject had a non-response during study.
    End point type
    Secondary
    End point timeframe
    Final assessment
    End point values
    		 EVALUABLE SUBJECTS
    Number of subjects analysed
    115
    Units: months
    median (inter-quartile range (Q1-Q3))
        NA
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Immune response by cohort

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    End point title
    		 Immune response by cohort
    End point description
    The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, by cohort (specified in section 3.): i) between 3 and 12 months after the last dose before ICF signature; and ii) at the final study assessment timepoint, namely at 6 months (+/- 4 weeks) after baseline assessment or 6 months (+ 4 weeks/- 8 weeks) after the first booster dose after ICF signature, if a booster dose is administered during the study per local / national health policy guidelines. Of the 115 evaluable subjects: *) 107 evaluable at baseline *) 52 evaluable at post-boost *) 56 evaluable at final assessment Immune response 100% in each cohort at each time cohort A1+A2 A3 B C baseline 56/56 17/17 9/9 25/25 post-boost 25/25 12/12 6/6 9/9 final 30/30 8/8 4/4 14/14
    End point type
    Secondary
    End point timeframe
    Baseline, Post-boost and Final Assessment
    End point values
    		 EVALUABLE SUBJECTS
    Number of subjects analysed
    115
    Units: Subjects
        Immune response rate
    115
    No statistical analyses for this end point

    Post-hoc: Absolute Titers of Anti-Spike Antibodies at baseline

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    End point title
    		 Absolute Titers of Anti-Spike Antibodies at baseline
    End point description
    At baseline, the overall median anti-Spike antibody titer was 9,017 U/mL [IQR, 2,180–26,871], with a significant difference observed across cohorts (p=0.005). Patients in cohort A.3 exhibited lower titers (3,875 U/mL [IQR, 202–13,863]) compared to those in cohort A.1–2 (11,293 U/mL [IQR, 3,359–26,487], p=0.003) and in cohort C (8,828 U/mL [IQR, 3,785–28,582], p=0.07). Patients in cohort B had the lowest titers (330 U/mL [IQR, 107–2,888]), which were significantly lower than those in cohort A.1–2 (p=0.004) and cohort C (p=0.02).
    End point type
    Post-hoc
    End point timeframe
    baseline
    End point values
    		 EVALUABLE SUBJECTS
    Number of subjects analysed
    107 [3]
    Units: U/mL
        median (inter-quartile range (Q1-Q3))
    9.017 (2.180 to 26.871)
    Notes
    [3] - N=107 evaluable at baseline
    No statistical analyses for this end point

    Post-hoc: Absolute Titers of Anti-Spike Antibodies at post-boost

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    End point title
    		 Absolute Titers of Anti-Spike Antibodies at post-boost
    End point description
    At post-booster timepoint, the overall median anti-Spike antibody increased to 30,079 U/mL [IQR, 13,669–56,337], with significant differences across cohorts (p=0.012). Patients in cohort B again exhibited the lowest titers (1,504 U/mL [IQR, 287–21,182]), which were significantly lower than those in cohort A.1–2 (35,239 U/mL [IQR, 23,192–64,098], p=0.005) and in cohort C (30,414 U/mL [IQR, 9,722–39,142], p=0.03). While patients in cohort A.3 had numerically lower titers (25,094 U/mL [IQR, 3,666–62,819]) than cohort A.1–2 and cohort C, these differences were not statistically significant (p=0.18 and p=0.55, respectively)
    End point type
    Post-hoc
    End point timeframe
    post-boost
    End point values
    		 EVALUABLE SUBJECTS
    Number of subjects analysed
    52 [4]
    Units: U/mL
        median (inter-quartile range (Q1-Q3))
    30.079 (13.669 to 56.337)
    Notes
    [4] - 52 evaluable subjects at post-boost
    No statistical analyses for this end point

    Post-hoc: Absolute Titers of Anti-Spike Antibodies at final study assessment

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    End point title
    		 Absolute Titers of Anti-Spike Antibodies at final study assessment
    End point description
    At the final study assessment, the overall median anti-Spike antibody titer was 10,024 U/mL [IQR, 5,040–25,814], with no statistically significant difference across cohorts (p=0.053). Median titers remained numerically lower in patients in cohort A.3 (7,720 U/mL [IQR, 2,334–14,041]) and cohort B (3,941 U/mL [IQR, 1,193–6,433]) compared to those in cohort A.1–2 (10,106 U/mL [IQR, 5,302–24,628]) and in cohort C (13,659 U/mL [IQR, 8,792–31,475])
    End point type
    Post-hoc
    End point timeframe
    final study assessment
    End point values
    		 EVALUABLE SUBJECTS
    Number of subjects analysed
    56 [5]
    Units: U/mL
        median (inter-quartile range (Q1-Q3))
    10.024 (5.040 to 25.814)
    Notes
    [5] - 56 evaluable at final study assessment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Frequency threshold for reporting non-serious adverse events: 1%
    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 have been reported in the 152 included subjects.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jan 2022
    New amended other study documents New amended patient information sheet/informed consent (including addendum) New amended protocol
    14 Apr 2022
    New amended patient information sheet/informed consent (including addendum) New amended protocol
    02 May 2022
    New amended patient information sheet/informed consent (including addendum) New amended protocol
    30 Jun 2022
    Addition of at least a new site or a site whose LEC did not reply initially or moved site
    06 Oct 2022
    New amended patient information sheet/informed consent (including addendum) New amended protocol New amended documents or information related to IMP or IMPD
    02 Feb 2023
    New amended patient information sheet/informed consent (including addendum) New amended protocol New amended Reference Safety Information New amended documents or information related to IMP or IMPD
    16 Nov 2023
    New amended patient information sheet/informed consent (including addendum) New amended protocol New amended Reference Safety Information New amended documents or information related to IMP or IMPD

    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.
    The trial has been stopped prematurely due to slow accrual. All subjects had an immune response, resulting in a total immune response rate in all cohorts. Assessing differences in immune response according to subjects’characteristics was not possible
    For support, Contact us.
    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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