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    Summary
    EudraCT Number:2021-000868-30
    Sponsor's Protocol Code Number:NL76215.042.20
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-17
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000868-30
    A.3Full title of the trial
    The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant
    De immuun respons en veiligheid van COVID-19 vaccinatie in patiënten met chronische nierziekten, dialyse- of een niertransplantaat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy and safety of COVID-19 vaccination in patients with a kidney disease
    Effectiviteit en veiligheid van COVID-19 vaccinatie in patiënten met een nierziekte
    A.3.2Name or abbreviated title of the trial where available
    The RECOVAC IR study
    DE RECOVAC IR studie
    A.4.1Sponsor's protocol code numberNL76215.042.20
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04741386
    A.5.4Other Identifiers
    Name:RECOVACNumber:consortium
    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 SponsorRECOVAC consortium
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRECOVAC consortium
    B.5.2Functional name of contact pointstudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503616161
    B.5.6E-maila.l.messchendorp@umcg.nl
    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 No
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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
    COVID-19 is associated with increased morbidity and mortality in kidney transplant recipients (KTR) and patients with chronic kidneydisease (CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would be of great clinical importance in these patients.However, SARS-CoV-2 vaccination studies have excluded KTR and patients with CKD so-far. This will be the subject of this trial.
    COVID-19 wordt in verband gebracht met verhoogde morbiditeit en mortaliteit bij niertransplantatie patienten en patiënten metchronische nierziekte (CKD). Daarom zou een potentieel effectieve SARS-CoV-2-vaccinatie bij deze patiënten van groot klinisch belang zijn. SARS-CoV-2-vaccinatiestudies hebben tot dusver niertransplantatie ontvangers en patiënten met CKD echter uitgesloten. Dit zal het onderwerp van deze studie worden
    E.1.1.1Medical condition in easily understood language
    The course of corona disease 2019 (COVID-19) is worse in kidney disease patients. A safe and effective vaccin against COVID-19 is crucial in these patients.
    Corona ziekte 2019 (COVID-19) heeft een ernstiger beloop in patiënten met een nierziekte. Een veilig en goed werkend vaccin is van cruciaal belang in deze patiënten.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061105
    E.1.2Term Dialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 immunization
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084463
    E.1.2Term SARS-CoV-2 immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of vaccination against COVID-19 in patients with CKD4/5, patients on dialysis, and kidneytransplant recipients as compared to controls.

    The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as
    responders or non-responders. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group.
    Het beoordelen van de effectiviteit en veiligheid van COVID-19 vaccinatie bij patiënten met CKD4/5, dialyse patiënten enniertransplantatie patiënten in vergelijking met controles.

    Het primaire eindpunt is de op antilichamen gebaseerde immuunrespons op dag 28 na de tweede vaccinatie. Deelnemers worden geclassificeerd als responders of non-responders. Het percentage responders van elk patiëntencohort wordt vergeleken met het percentage responders in de controlegroep.
    E.2.2Secondary objectives of the trial
    Secondary endpoints include longevity of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity.
    Secundaire eindpunten zijn onder meer de immuunrespons na 6 en 12 maanden en niveaus van SARS-CoV-2-specifieke T- en B-cel responsen.
    Veiligheid is een secundair eindpunt dat zal worden gerapporteerd in termen van het aantal lokale en systemische ongewenste voorvallen (AE's) ingedeeld naar ernst.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
    2. Age of 18 years or older
    3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
    4. Either
    - CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI
    - Hemodialysis, or peritoneal dialysis
    - Kidney transplant recipient at least 6 weeks after transplantation
    - Partner, sibling, or other family member of participating patient with eGFR > 45 ml/min * 1,73 m2
    1. Alle patiënten moeten in aanmerking komen voor vaccinatie met COVID-19 zoals beschreven in de instructiesvan de fabrikant.
    2. Leeftijd van 18 jaar of ouder
    3. In staat om het doel en de risico's van het onderzoek te begrijpen, volledig geïnformeerd en schriftelijkegeïnformeerde toestemming te geven (ondertekend formulier voor geïnformeerde toestemming is verkregen)
    4. Ofwel
    - CKD4 / 5, met een eGFR <30 ml / min * 1,73 m2 door CKD-EPI
    - Hemodialyse of peritoneale dialyse
    - Niertransplantatie ontvanger ten minste 6 weken na transplantatie
    - Partner, huisgenoot of ander familielid van deelnemende patiënt met eGFR > 45 ml/min * 1,73 m2 door CKD-EPI
    E.4Principal exclusion criteria
    -History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) toany component of the study intervention(s).
    -Multi-organ recipients
    -Previous or active COVID-19 disease
    -Active (haematological) malignancy
    -Inherited immune deficiency
    -Infection with Human Immunodeficency Virus (HIV)
    -Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    -Voorgeschiedenis met ernstige bijwerkingen geassocieerd met vaccinatie en/of ernstige allergische reactie (anafylaxie) op enig component van de studie-interventie
    - Ontvangers van andere transplantaties met meerdere organen
    - Eerdere of actieve COVID-19-ziekte
    - Actieve (hematologische) maligniteit
    - Aangeboren immuundeficiëntie
    - Infectie met Human Immunodeficency Virus (HIV)
    - Bloedingsdiathese of aandoening die gepaard gaat met langdurige bloeding die naar de mening van de onderzoeker een contra-indicatie zou vormen voor intramusculaire injectie.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the antibody response after SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.
    Bepaling van de antilichaam response na SARS-CoV-2 vaccinatie in patiënten met CKD stadium 4/5, dialyse- of niertransplantatiepatiënten vergeleken met controles
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after complete vaccination
    28 dagen na complete vaccinatie
    E.5.2Secondary end point(s)
    Secondary Objectives:
    To assess in these groups of subjects after SARS-CoV 2 vaccination:
    1. durability of the antibody response
    2. the SARS-CoV-2-specific T and B cell response
    3. adverse events

    Exploratory Objectives:
    To assess in these groups of subjects after SARS-CoV 2 vaccination:
    4. the association between baseline (immune) parameters and the immune response to SARS-CoV-2 vaccination
    5. the neutralizing capacity of anti-COVID-19 antibodies
    6. the incidence of SARS-CoV-2 infection and outcome of COVID-19 disease during 12 months after SARS-CoV-2 vaccination
    Secundaire doelstellingen:
    Bepalen van:
    1. De duur van de antilichaamrespons
    2 De SARS-CoV-2 specifieke T en B cell response
    3 bijwerkingen

    Verkennende doestellingen:
    Bepalen van:
    4. de association van de baseline (immuun) parameters en de immuun repons op de SARS-CoV-2 vaccinatie
    5. de neutraliserende capaciteit van de anti-COVID-19 antilichamen
    6. de incidentie van SARS-CoV-2 infectie en uitkomst van COVID-19 ziekte gedurende 12 maanden na volledige vaccinatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 6 and 12 months after complete vaccination
    2. 28 days, 6 and 12 months after complete vaccination
    3. During complete study period
    4. Baseline, at second vaccination and 28 days, 6 and 12 months after complete vaccination
    5. See point 4
    6. During 12 months after comoplete vaccination
    1. 6 en 12 maanden na complete vaccinatie
    2. 28 dagen, 6 and 12 maanden na complete vaccinatie
    3. Gedurende de hele studie periode
    4. Baseline, bij tweede vaccinatie en 28 dagen, 6 en 12 maanden na complete vaccinatie
    5. Zie punt 4
    6. Gedurende 12 maanden na complete vaccinatie
    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 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 concerned4
    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 Yes
    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
    Laatste visite van de laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    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: 570
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with end stage kidney disease, on dialysis or with a kidney transplant
    Patiënten met eind stadium nierziekte, dialyse patiënten en niertransplantatiepatiënten
    F.4 Planned number of subjects to be included
    F.4.1In the member state850
    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
    Geen
    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 Decision2021-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-23
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