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    The EU Clinical Trials Register currently displays   41046   clinical trials with a EudraCT protocol, of which   6718   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-000930-32
    Sponsor's Protocol Code Number:SJ2021005
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-000930-32
    A.3Full title of the trial
    COVID-19: Documentation of humoral and cellular immune response of hemodialysis patients after vaccination against SARS-CoV-2
    COVID-19: Documentatie van humorale en cellulaire immuunrespons van hemodialyse patiënten na vaccinatie tegen SARS-CoV-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19: Determination of effect of COVID vaccination on immunity of hemodialysis patients
    COVID-19: Bepaling van effect van COVID-vaccinatie op de immuniteit van hemodialyse patiënten
    A.3.2Name or abbreviated title of the trial where available
    COVID-19: immune response after COVID-vaccination in hemodialysis patients
    COVID-19: immuunrespons na COVID-vaccinatie in hemodialyse patiënten
    A.4.1Sponsor's protocol code numberSJ2021005
    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 SponsorAZ Sint-Jan Brugge-Oostende AV
    B.1.3.4CountryBelgium
    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 supportVZW NIERZIEKTEN EN INFECTIEZIEKTEN AZ SINT-JAN BRUGGE-OOSTENDE
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationclinical trial center
    B.5.2Functional name of contact pointCTC
    B.5.3 Address:
    B.5.3.1Street AddressRuddershove 10
    B.5.3.2Town/ cityBrugge
    B.5.3.3Post code8000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003250453289
    B.5.6E-mailctc@azsintjan.be
    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 Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Concentrate and solvent for solution 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 INNNAP
    D.3.9.1CAS number 2417899-77-3
    D.3.9.2Current sponsor codeBNT162b2
    D.3.9.3Other descriptive nameTozinameran
    D.3.9.4EV Substance CodeSUB210693
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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) Yes
    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.IMP: 2
    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 Moderna dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Concentrate and solvent for solution 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 INNCX-024414
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine Moderna (CX-024414)
    D.3.9.4EV Substance CodeSUB207171
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) Yes
    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
    hemodialysis patients
    hemodialysis patients with comorbidities
    E.1.1.1Medical condition in easily understood language
    patients with renal failure requiring renal function replacement therapy
    (i.e. hemodialysis)
    patients with renal failure requiring renal function replacement therapy
    with other medical conditions
    patiënten met nierfalen die nierfunctievervangende therapie (d.i.
    hemodialyse) vereisen
    patiënten met nierfalen die nierfunctievervangende therapie met
    bijkomende aandoeningen
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In this trial we aim to measure the humoral and immune response after
    vaccination with one of 2 types of COVID-19 vaccines, recently approved
    by the EMA for use in the European Union: the BNT162b2 mRNA COVID-
    19 vaccine from BioNTec/Pfizer and the SARS-CoV-2 mRNA-1273 vaccine
    from Moderna. This in hemodialysis patients of 18 years and older, in
    comparison with patients with comorbidities and healthy volunteers.
    Blood sampling will be performed during dialysis via catheter or AV
    fistula. In the healthy volunteers and patients with comorbidities, blood
    will be drawn. Exact timing of blood draws will be point zero (day of
    vaccination to 1 week before vaccine administration), and 4 weeks (+/-3
    days), 8 weeks (+/-3 days) and 24 weeks (+/-3 days) after vaccine
    administration.
    Patients will be recruited in Belgium in the following hospitals: AZ Sint-
    Jan Brugge-Oostende AV (coordinating site), Zuid-Oost Limburg, AZ
    Groeninge, OLV Aalst, and curando vzw.
    E.2.2Secondary objectives of the trial
    analysis of predictive factors (clinical and immunological) for the
    immune response in hemodialysis patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consecutive series of hemodialysis patients receiving Covid-19 RNA
    vaccine. A target of at least 100 patients is envisioned. Minimum age for
    inclusion is 18 years.
    2. at least thirty healthy volunteers receiving Covid-19 RNA vaccine.
    Minimum age for inclusion is 18 years. Individuals with immune
    disorders cannot participate.
    3. at least thirty patients older than 50 years with at least 1
    comorbidity (such as heart failure, diabetes, COPD, liver cirrhosis,....),
    but no chronic renal insufficiency. Minimum age for inclusion is 18 years.
    Only patients who receive vaccine on a voluntary basis will be included.
    E.4Principal exclusion criteria
    - patients younger than 18 years old
    - patients who do not voluntarily ask for a COVID-vaccination
    - patients not eligible according to abovementioned inclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    1. Measurement of anti-S and anti-N antibodies.
    SARS-CoV-2 IgG against the S and N protein will be quantitatively
    measured by chemiluminescent microparticle immunoassay (Architect-I
    System by Abbott, Sligo, Ireland).
    2. Measurement of interferon gamma production.
    Interferon production by SARS-CoV specific T cells will be measured
    using the QuantiFERON Sars-CoV-2 kit (Qiagen).
    3. Baseline immune status (only in hemodialysis patients).
    Before vaccination the following parameters are determined: number of
    lymphocytes, number of CD4 positive lymphocytes, number of CD8
    positive lymphocytes, number of CD19 positive lymphocytes, B and T cell
    memory subsets, protein electrophoresis, C3, C4, total IgG, IgA and IgM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time of blood sampling is point zero (day of vaccination to 1 week
    before vaccine administration), and 4 weeks (+/-3 days), 8 weeks (+/-3
    days) and 24 weeks (+/-3 days) after vaccine administration.
    E.5.2Secondary end point(s)
    identical to primary end point data collection
    E.5.2.1Timepoint(s) of evaluation of this end point
    identical to primary end point timepoints, namely Time of blood sampling
    is point zero (day of vaccination to 1 week before vaccine
    administration), and 4 weeks (+/-3 days), 8 weeks (+/-3 days) and 24
    weeks (+/-3 days) after vaccine administration.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    search for biomarkers predictive for efficacy in this target population
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    the trial follows the routine practice of COVID-vaccination, except for additional blood sampling
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    other pathology - hemodialysis vs comorbidity vs healthy controls
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 years
    E.8.9.1In the Member State concerned months6
    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: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state580
    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 Decision2021-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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