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    Clinical Trial Results:
    The impact of BNT162b2 mRNA vaccine on adaptive and innate immune responses

    Summary
    EudraCT number
    		 2021-000182-33
    Trial protocol
    		 NL  
    Global end of trial date
    21 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2023
    First version publication date
    21 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    76421
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    Konstantin Föhse, Radboudumc, konstantin.fohse@radboudumc.nl
    Scientific contact
    Konstantin Föhse, Radboudumc, konstantin.fohse@radboudumc.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
    05 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to analyze the effects of BNT162b2 vaccination on both the specific adaptive immune responses and the responsiveness of human immune cells upon stimulation with heterologous pathogens.
    Protection of trial subjects
    Data from trial subjects was pseudonymized.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthcare workers from the Radboud University Medical Center, Nijmegen were enrolled who received the BNT162b2 mRNA COVID-19 vaccine as per national vaccination campaign and provided informed consent. Key exclusion criteria included a medical history of COVID-19.

    Period 1
    Period 1 title
    T3
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participants
    Arm description
    		 According to inclusion criterion: subjects who were vaccinated with BNT162b2 as per national vaccination campaign
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    30 µg

    Number of subjects in period 1
    		All participants
    Started
    16
    Completed
    13
    Not completed
    3
         Dropped out because they had COVID-19 during study
    3
    Period 2
    Period 2 title
    T4
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participants
    Arm description
    		 According to inclusion criterion: subjects who were vaccinated with BNT162b2 as per national vaccination campaign
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    30 µg

    Number of subjects in period 2
    		All participants
    Started
    13
    Completed
    13
    Period 3
    Period 3 title
    T5
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participants
    Arm description
    		 According to inclusion criterion: subjects who were vaccinated with BNT162b2 as per national vaccination campaign
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    30 µg

    Number of subjects in period 3
    		All participants
    Started
    13
    Completed
    13

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 According to inclusion criterion: subjects who were vaccinated with BNT162b2 as per national vaccination campaign
    Reporting group title
    All participants
    Reporting group description
    		 According to inclusion criterion: subjects who were vaccinated with BNT162b2 as per national vaccination campaign
    Reporting group title
    All participants
    Reporting group description
    		 According to inclusion criterion: subjects who were vaccinated with BNT162b2 as per national vaccination campaign

    Primary: Neutralizing capacity of the serum against the D614G strain

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    End point title
    		 Neutralizing capacity of the serum against the D614G strain
    End point description
    End point type
    Primary
    End point timeframe
    T2 (Two weeks after the second dose) T3 (Six months after the first dose) T4 (Four weeks after the booster vaccination, which was approximately one year after the first dose).
    End point values
    		 All participants All participants All participants
    Number of subjects analysed
    13 [1]
    13
    13
    Units: IU/ml
    454
    89
    1533
    Notes
    [1] - 3 drop-outs because they had COVID-19 during study period
    Statistical analysis title
    		 Comparing geometric mean titers
    Comparison groups
    All participants v All participants v All participants
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Full study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Frequency threshold for reporting non-serious adverse events: 0%
    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 were reported by the subjects. Common side effects of vaccination or blood collection were not regarded as adverse events, as pre-defined in the protocol.

    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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