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    Clinical Trial Results:
    A Phase IV Vaccine Study under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE PLUS)

    Summary
    EudraCT number
    		 2021-003188-90
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Feb 2025
    First version publication date
    28 Feb 2025
    Other versions
    Summary report(s)
    		 End Note

    Trial information

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    Trial identification
    Sponsor protocol code
    ENFORCE-PLUS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06360744
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHIP - Rigshospitalet - University of Copenhagen
    Sponsor organisation address
    Blegdamsvej 9, Section 2100, Copenhagen, Denmark, 2100
    Public contact
    Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, 45 3545 5757, jens.lundgren@regionh.dk
    Scientific contact
    Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, 45 3545 5757, jens.lundgren@regionh.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
    31 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to clarify whether vaccination with the Johnson & Johnson/Janssen vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the Johnson & Johnson/Janssen vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies than mRNA vaccines
    Protection of trial subjects
    Informed Consent is obtained from the participant before any trial -related procedures were conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The Danish COVID-19 vaccination programme does not include vaccination with the SARS-CoV-2 vaccine from Janssen, however vaccination with this vaccine is approved via a medical prescription. The ENFORCE PLUS protocol is proposed to be linked to ENFORCE with additional safety measures introduced the first month after vaccination.

    Pre-assignment
    Screening details
    		 The difference between the ENFORCE trial (EudraCT no.2020-006003) and this ENFORCE PLUS trial was the J&J vaccine was given by the trial staff and the ENFORCE participants received their vaccination in the Danish Vaccination Programme.

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

    Arms
    Arm title
    		 Vaccine Janssen
    Arm description
    		 The vaccine is used according to the approved Summary of Product Characteriestics.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Jcovden.
    Investigational medicinal product code
    Other name
    Janssen/Johnson & Johnson CoV-2 vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine is used according to the approved Summary of Product.

    Number of subjects in period 1
    		Vaccine Janssen
    Started
    25
    Completed
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Entire trial
    Reporting group description
    		 -

    Reporting group values
    		 Entire trial Total
    Number of subjects
    		 25 25
    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)
    		 25 25
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Vaccine Janssen
    Reporting group description
    		 The vaccine is used according to the approved Summary of Product Characteriestics.

    Primary: Antibody Level

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    End point title
    		 Antibody Level [1]
    End point description
    Primary Outcome: Minimal protective neutralising antibody titre (MPNAT) i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected. MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 60. We will use two different large-scale methods. 1. ELISA detection of total serum Ig to the Receptor Binding Domain (Wantai), this specific method will be stopped after January 2023 as the positive rate has reached 99%. 2. A multiantigen serological test including both the N-terminal Domain (NTD), The Receptor Binding Domain (RBD), the complete Spike (S) protein and the Nucleocapsid (NC) protein as antigens (from Mesoscale). Additionally, an ACE2 competition assay will be used to score the receptor blocking potential of antibodies raised by vaccination (Mesoscale).
    End point type
    Primary
    End point timeframe
    Antibody level will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24
    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: The statistical analysis are described in the ENFORCE trial
    End point values
    		 Vaccine Janssen
    Number of subjects analysed
    25
    Units: Number of subjects analysed
        AUH antibody data enrollment (N, % of total)
    23
        AUH antibody data, 3 month after first vaccination
    21
        AUH antibody data, 6 month after first vaccination
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 month after vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Vaccine Janssen
    Reporting group description
    		 Number of persons with at least one Adverse Event reported

    Serious adverse events
    		 Vaccine Janssen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Vaccine Janssen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    Product issues
    Influenza like illness
         subjects affected / exposed
    1 / 25 (4.00%)
         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.
    Since all 25 participants had completed their thir visit (3 month after vaccination) and already were in the follow-up phase, completely identical to the ENFORCE protocoll the participants were transferred for their follow-up to the ENFORCE database.
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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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