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    Summary
    EudraCT Number:2021-003188-90
    Sponsor's Protocol Code Number:ENFORCE-PLUS
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2021-003188-90
    A.3Full title of the trial
    A Phase IV Vaccine Study under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE PLUS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Same as above
    A.3.2Name or abbreviated title of the trial where available
    ENFORCE
    A.4.1Sponsor's protocol code numberENFORCE-PLUS
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHIP - Rigshospitalet - University of Copenhagen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSundheds og Ældreministeriet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHIP - Rigshospitalet, University of Copenhagen
    B.5.2Functional name of contact pointJens Lundgren
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number453545 5757
    B.5.5Fax number453647 3340
    B.5.6E-mailjens.lundgren@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine(AD26.CoV2-S [recombinant])
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCOVID-19 Vaccine Janssen
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOVID-19 Vaccine Janssen
    D.3.9.3Other descriptive nameCOVID-19 Vaccine Janssen (Ad26.COV2.S)
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The primary objective of the study is to assess if the SARS-CoV-2 vaccine Johnson & Johnson/Janssen results in change in number and activation of platelets and anti-PF4 level. As well as to compare whether the Johnson & Johnson/Janssen vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.
    The Danish Medicines Agency has approved the vaccine from Johnson & Johnson/Janssen for use in Denmark, however it is not currently part of the national vaccine programme.
    E.1.1.1Medical condition in easily understood language
    Same as above
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary objectives of the trial
    The secondary objectives are changes in the following biomarkers:
    • Platelet count, D-dimer, fibrinogen (lab. VITT)
    • Platelet activity: TGFß, P-selectin
    • Possibly thrombus generation
    • Vascular and immunological markers
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Appendix 3 to the protocol:
    Under separate participant informed consent, a cohort will be established including 250 patients (100 healthy and 150 high-risk individuals) from each vaccine group. Live cells (PBMCs) and PAX tubes (for transcriptomic analysis) will be collected for the participants in this cohort. Several work packages or sub-studies will be embedded within this cohort addressing basic and translational research questions requiring additional sampling of biological material as described below.
    Work package 1 (WP1): Immunogenicity: Biobanking of live cells (liquid nitrogen)
    Work package 2 (WP2): Characterization of polyclonal antibody responses to SARS-CoV-2 variants
    Work package 3 (WP3): Characterization of adaptive immune response in individuals with breakthrough infections
    Work package 4 (WP4): Cellular Immunity: Longitudinal immunoprofiling of vaccine responses in SARS CoV-2 vaccinated individuals
    E.3Principal inclusion criteria
    1. Written informed consent obtained before any trial related procedures are performed
    2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan/Tilvalgsordningen)
    3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
    E.4Principal exclusion criteria
    1. Male and female under the age of 18
    2. Any subgroup of individuals for which the vaccines are contra-indicated
    3. Previous SARS-CoV-2 vaccination
    Specific for the Johnson & Johnson vaccine:
    4. Experience of a serious allergic reaction after injection of any other vaccine
    5. Serious infection with high fever (> 38 0C)
    A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
    6. Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
    7. Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in the level of anti-PF4-antibodies from pre- to post vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24.

    The exact value of the MPNAT is currently not precisely defined, but is expected to be documented within short periods of time based on analyses across the ongoing phase III trials, associating titre levels with risk of breakthrough infection in the actively vaccinated group.

    As the exact value of the MPNAT remains to be determined, and until that time point has arisen, a priori (i.e. while remaining blinded to the actually obtained data) of the actually defined cut-offs in neutralising titres that reasonable can serve as proxy for the MPNAT will be recommended by an expert advisory panel, and endorsed by the study leadership
    E.5.2Secondary end point(s)
    See under objectives
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1000
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-12-31
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