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    Clinical Trial Results:
    Prospective monitoring of immune response following COVID-19 vaccination in children with cancer

    Summary
    EudraCT number
    		 2021-003388-90
    Trial protocol
    		 NL  
    Global end of trial date
    31 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2024
    First version publication date
    08 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PB21VAC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Princess Máxima Center for pediatric oncology
    Sponsor organisation address
    Heidelberglaan 25, Utrecht, Netherlands, 3584 CS
    Public contact
    Prof. Dr. W.J.E. Tissing, Princess Máxima Center for Pediatric Oncology, 0031 88972 72 72, trialmanagement@prinsesmaximacentrum.nl
    Scientific contact
    Prof. Dr. W.J.E. Tissing, Princess Máxima Center for Pediatric Oncology, 0031 88972 72 72, trialmanagement@prinsesmaximacentrum.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 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancer as compared to healthy children
    Protection of trial subjects
    Patients were vaccinated according to the Dutch national vaccination program. Standard of Care, no additional protection.
    Background therapy
    		 Patients were vaccinated according to the Dutch national vaccination program. They received a 2-dose series of 10 µg (5–11 years) or 30 µg (12–17 years) BNT162b2 (Pfizer/BioNTech) mRNA COVID-19 Vaccine. Later on, immunocompromised children aged 12 and above, were also offered an additional third vaccination.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    17 Jul 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
    Netherlands: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    36
    Adolescents (12-17 years)
    53
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Dates of recruitment period 17/07/2021 – 16/02/2023. All participants were patients treated at the Princess Máxima Center. A letter containing study information was send to their home address to invite them to participate in blood sampling. Written informed consent was obtained from all study participants and parents/legal guardians.

    Pre-assignment
    Screening details
    		 Patients treated at the Princess Máxima Center because of hematological, solid or neurological malignancies, or allogenic stem cell transplantation because of non-malignant disease, were identified from electronic medical records.

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

    Arms
    Arm title
    		 Entire cohort
    Arm description
    		 -
    Arm type
    		 intervention acc to SOC

    Investigational medicinal product name
    BNT162b2 BioNTech/Pfizer COVID-19 Vaccine
    Investigational medicinal product code
    Other name
    Cominaty
    Pharmaceutical forms
    Concentrate for dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    For children aged 12-17 years - Comirnaty is administered intramuscularly after dilution as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status. For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty should be administered at least 3 months after the most recent dose of a COVID-19 vaccine. For children aged 5-11 years - Comirnaty 10 micrograms/dose is administered intramuscularly after dilution as a single dose of 0.2 mL for children 5 to 11 years of age regardless of prior COVID-19 vaccination status. For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

    Number of subjects in period 1
    		Entire cohort
    Started
    89
    Completed
    89

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Recruitment
    Reporting group description
    		 All patients recruited started and completed treatment

    Reporting group values
    		 Recruitment Total
    Number of subjects
    		 89 89
    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)
    		 36 36
        Adolescents (12-17 years)
    		 53 53
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 45 45
        Male
    		 44 44
    Subject analysis sets

    Subject analysis set title
    Tx < 6 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Children who received chemo or immunotherapy less than 6 weeks before 1st vaccination

    Subject analysis set title
    Tx > 6 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Children who received chemo or immunotherapy more than 6 weeks before 1 st vaccination

    Subject analysis set title
    No Tx
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Children without a history of chemo or immunotherapy

    Subject analysis sets values
    		 Tx < 6 weeks Tx > 6 weeks No Tx
    Number of subjects
    39
    28
    6
    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)
    21
    7
    0
        Adolescents (12-17 years)
    18
    21
    6
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    18
    16
    3
        Male
    21
    12
    3

    End points

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    End points reporting groups
    Reporting group title
    Entire cohort
    Reporting group description
    		 -

    Subject analysis set title
    Tx < 6 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Children who received chemo or immunotherapy less than 6 weeks before 1st vaccination

    Subject analysis set title
    Tx > 6 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Children who received chemo or immunotherapy more than 6 weeks before 1 st vaccination

    Subject analysis set title
    No Tx
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Children without a history of chemo or immunotherapy

    Primary: Antibody based immune response to vaccination against SARS-CoV-2 1 month after the 2nd vaccination and 1 month after the 3rd vaccination

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    End point title
    		 Antibody based immune response to vaccination against SARS-CoV-2 1 month after the 2nd vaccination and 1 month after the 3rd vaccination
    End point description
    SARS-CoV-2 spike 1-specific antibody concentration at 28 (21–42) days after the 2nd and/or 3rd vaccination. Participants with anti-S1 levels >300 BAU/mL were classified as responders, between 10 and 300 BAU/mL as low responders and <10 BAU/mL as non-responders BAU=Binding antibody units
    End point type
    Primary
    End point timeframe
    Blood was sampled 28 days after the 2nd vaccination and when possible 28 days after the third vaccination
    End point values
    		 Tx < 6 weeks Tx > 6 weeks No Tx
    Number of subjects analysed
    39
    28
    6
    Units: BAU/mL
    number (not applicable)
        2 dose vaccination group – 28 days after 2nd vacci
    28
    18
    4
        3 dose vaccination group – 28 days after 3rd vacci
    10
    6
    0
        Hybrid group (2 vaccinations + infection)
    9
    7
    1
        Hybrid group (1 vaccination + infection)
    4
    4
    1
    Statistical analysis title
    		 SARS-CoV-2 specific antibody levels
    Statistical analysis description
    SARS-CoV-2 specific antibody levels following 2 dose vaccination in patients on treatment (Tx <6 weeks) and off treatment (Tx > 6 weeks) Mann-Whitney U test comparing SARS-CoV-2 specific antibody levels 1 month after 2-dose vaccination in patients with Tx <6 weeks and in patients with Tx >6 weeks
    Comparison groups
    Tx < 6 weeks v Tx > 6 weeks
    Number of subjects included in analysis
    67
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001
    Method
    		 Mann-Whitney U test
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Within 7 days after each vaccination (only for cohort I, children aged 12-17 years vaccinated at the Princess Máxima Center)
    Adverse event reporting additional description
    No adverse events were reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Entire cohort
    Reporting group description
    		 -

    Serious adverse events
    		 Entire cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 89 (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
    		 Entire cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 89 (0.00%)
    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: Reporting criteria were limited and intervention according to standard of care

    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.
    Not applicable

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37174028
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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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