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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-000515-24
    Sponsor's Protocol Code Number:NL76470.078.21
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000515-24
    A.3Full title of the trial
    Vaccination Against Covid in Primary Immune Deficiencies
    Covid-19 vaccinatie in primaire immuundeficienties
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination Against Covid in Primary Immune Deficiencies
    Covid-19 vaccinatie in patienten met aangeboren afweerstoornissen
    A.3.2Name or abbreviated title of the trial where available
    VACOPID
    A.4.1Sponsor's protocol code numberNL76470.078.21
    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 SponsorErasmus University Medical Center
    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 organisationErasmus University Medical Center
    B.5.2Functional name of contact pointProf.dr. R.P. Peeters
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.6E-mailr.peeters@erasmusmc.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 Yes
    D.2.1.1.1Trade name COVID-19 Vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L
    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 Dispersion for injection
    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 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    Patients with primary immunodeficiency disease, also known as inborn errors pf immunity, are vaccinated against COVID-19 using COVID-19 Vaccine Moderna. The vaccine has been approved for use in the Netherlands and all adults in the Netherlands are vaccinated according the the National Vaccination Campaign that started in January 2021
    Patienten met aangebopren stoornissen in het immuunsysteem worden gevaccineerd tegen COVID-19 met het Moderna Vaccin. Het vaccin is goedgekeurd voor gebruik in Nederland en alle volwassenen in Nederland zullen gevaccineerd worden in een Nationale Vaccinatie Campagne, welke is gestart in januari 2021
    E.1.1.1Medical condition in easily understood language
    People with an inherited defect in the immune system will be vaccinated against COVID-19
    Mensen met een eengaboren defect in het afweersysteem zullen ingeent worden tegen COVID-10
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10036700
    E.1.2Term Primary immunodeficiency syndromes
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess immunogenicity and safety of SARS-CoV-2 vaccination in patients with isolated antibody deficiencies, i.e. patients with immunoglobulin G (IgG) subclass deficiency and patients with selective antibody deficiency with normal immunoglobulins (SADNI), which are clinically characterized by an increased risk of infections.
    To explore immunogenicity and safety of SARS-CoV-2 vaccination in patients with Common Variable Immune Deficiency (CVID), Combined Immunodeficiency (CID), Chronic Granulomatous Disease (CGD) and X-linked agammaglobulinemia (XLA), which are clinically characterized by an increased risk of infections and immune dysregulation

    The primary endpoint is the antibody response in patients with an isolated antibody deficiency (selective IgG subclass deficiency or SADNI) on day 28 after vaccination
    Vaststellen van immunogeniciteit en veiligheid van SARS-CoV-2 vaccinatie in patienten met een geisoleerde antistofdeficientie , dit zijn patienten met een immuunglobuline G subklasse deficientie en patienten met een selectieve antistof deficiëntie met normale immuunglobulinen. Deze patienten worden klinisch gekenmerkt door een verhoogd risico op infecties.
    Evalueren van immunogeniciteitt en veiligheid van SARS-CoV-2 vaccinatie in patienten met Common Variable Immune Deficiency (CVID), Combined Immunodeficiency (CID), Chronic Granulomatous Disease (CGD) en X-linked agammaglobulinemia (XLA). Deze patienten hebben een verhoogd risico op infecties en ontregeling van het immuunsysteem (immuundysregulatie).

    Primair eindpunt is de antistof respons in patiënten met een geïsoleerde antistof deficiëntie (selectieve IgG subklasse deficiëntie of selectieve antistof deficiëntie met normale immuunglobulinen) op dag 28 na vaccinatie
    E.2.2Secondary objectives of the trial
    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. Other secondary endpoints include monitoring of occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses.
    Evaluation of the antibody response in patients with CVID, CID, CGD or XLA on day 28 after vaccination will be a secondary endpoint of this study. Other secondary endpoints for patients with CVID, CID, CGD or XLA include safety, occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses
    Veiligheid is een secundair eindpunt, gemeten aan hand van lokale en systemische reacties en ernst van deze reacties. Andere secundaire uitkomsten zijn: monitoren van optreden van COVID-19 infectie ondanks vaccinatie, ontstaan van vaccin escape varianten van het virus, meten van response na eerste vaccinatie, het bepalen van de duur van de immuunrespons op 6 en 12 maanden na vaccinatie en het meten van specifiek T en B cel responsen.

    Evaluatie van de antistof respons in patienten met CVID, CID, CGD en XLA op dag 28 na vaccinatie is een secundair eindpunt van dze studie. Andere secundaire uitkomsten in deze groep zijn monitoren van optreden van COVID-19 infectie ondanks vaccinatie, ontstaan van vaccin escape varianten van het virus, meten van response na eerste vaccinatie, het bepalen van de duur van de immuunrespons op 6 en 12 maanden na vaccinatie en het meten van specifiek T en B cel responsen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible for the study if all of the following apply:
    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. A diagnosis of either one of the IUIS criteria based diagnoses below:
    - CVID, with or without use of immunosuppressive therapy
    - CID
    - CGD
    - XLA
    - Selective IgG subclass deficiency
    - SADNI
    - Partners, sibling or other family member from patient (not suffering from a PID)
    Een van onderstaande diagnoses:
    CVID, met of zonder gebruik van afweeronderdrukkende medicatie immuunsuppresiva
    CID
    CGD
    XLA
    Selectieve IgG subklasse deficiëntie
    SADNI

    18 jaar of ouder.
    In staat toestemming te geven
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
    Women who are pregnant or breastfeeding
    Active (haematological) malignancy
    HIV (Human Immunodeficiency Virus)
    Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    Kwaadaardige ziekte die op dit moment onvolledig genezen is
    HIV (Humaan Immunodeficiency Virus)
    Zwanger of borstvoeding gevend
    Eerdere ernstige allergische reactie op een vaccin
    Aandoening waarbij een hoger bloedingsrisico bestaat, waardoor een injectie in de spieren kan leiden tot complicaties
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the antibody response in patients with an isolated antibody deficiency (selective IgG subclass deficiency or SADNI) on day 28 after vaccination
    Primair eindpunt is de antistof respons in patiënten met een geïsoleerde antistof deficiëntie (selectieve IgG subklasse deficiëntie of selectieve antistof deficiëntie met normale immuunglobulinen) op dag 28 na vaccinatie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will receive two vacinations, according tomanufacturer's protocol, with an interval of 28 days. Primary endpoint will be evaluated at day 28 after second vaccination.
    Patienten ontvangen twee vacinaties, in pvereenstemming met het landelijke vacinateoiprotocol, met een interval van 28 dagen.
    Primaire eindpunt zal bepaald worden op dag 28 na tweede vaccinatie
    E.5.2Secondary end point(s)
    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. Other secondary endpoints include monitoring of occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses.
    Evaluation of the antibody response in patients with CVID, CID, CGD or XLA on day 28 after vaccination will be a secondary endpoint of this study. Other secondary endpoints for patients with CVID, CID, CGD or XLA include safety, occurrence of infection despite vaccination, development of vaccine escape variants of the virus, mounting of response after 1st vaccination, durability of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses
    Veiligheid is een secundair eindpunt, gemeten aan hand van lokale en systemische reacties en ernst van deze reacties. Andere secundaire uitkomsten zijn: monitoren van optreden van COVID-19 infectie ondanks vaccinatie, ontstaan van vaccin escape varianten van het virus, meten van response na eerste vaccinatie, het bepalen van de duur van de immuunrespons op 6 en 12 maanden na vaccinatie en het meten van specifiek T en B cel responsen.

    Evaluatie van de antistof respons in patienten met CVID, CID, CGD en XLA op dag 28 na vaccinatie is een secundair eindpunt van dze studie. Andere secundaire uitkomsten in deze groep zijn monitoren van optreden van COVID-19 infectie ondanks vaccinatie, ontstaan van vaccin escape varianten van het virus, meten van response na eerste vaccinatie, het bepalen van de duur van de immuunrespons op 6 en 12 maanden na vaccinatie en het meten van specifiek T en B cel responsen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpints wil be determined after 6 months and 12 months of start study
    Secundaire eindpunten worden bepaald na 6 en 12 maanden na starten studie
    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.8.3 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 concerned7
    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
    End of trial will be 12 months after last participant received second vaccination
    Einde van de studie is op 12 maanden nadat de laatste deelnemer het tweede vaccinatie heeft ontvangen
    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 months3
    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: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state700
    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 Decision2021-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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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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