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    Summary
    EudraCT Number:2021-000182-33
    Sponsor's Protocol Code Number:76421
    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:2021-01-21
    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 number2021-000182-33
    A.3Full title of the trial
    Effect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccine in health care workers
    Effect van Bacillus Calmette-Guérin vaccinatie op de immunogeniciteit van het mRNA BNT162b2 COVID-19 vaccin bij gezondheidsmedewerkers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of BCG vaccination, originally made to prevent tuberculosis, on the immune response to the COVID-19 vaccine in health care workers
    Impact van BCG vaccinatie, oorspronkelijk ontwikkeld ter voorkoming van tuberculose, op de immuunreactie op het COVID-19 vaccin bij gezondheidsmedewerkers
    A.3.2Name or abbreviated title of the trial where available
    COMBI study
    COMBI studie
    A.4.1Sponsor's protocol code number76421
    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 SponsorRadboudumc
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointKonstantin Föhse
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 8 (Routenr 463)
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailkonstantin.fohse@radboudumc.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 Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameComirnaty
    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.3.11 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
    Immunogenicity of the mRNA BNT162b2 COVID-19 vaccine.
    Immunogeniciteit van het mRNA BNT162b2 COVID-19 vaccin.
    E.1.1.1Medical condition in easily understood language
    Immune response to the COVID-19 vaccine.
    Immuunreactie op het COVID-19 vaccin.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The main objective is to analyze whether BCG-vaccination prior to COVID-19 vaccination can enhance the immunogenicity of the COVID‑19 mRNA vaccine developed by BioNTech and Pfizer.
    Het doel is te onderzoeken of BCG vaccinatiie de immunogeniciteit kan verhogen van het COVID-19 mRNA vaccin ontwikkeld door BioNTech/Pfizer.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to determine if antibody concentrations against SARS-CoV-2 antigens in nasal mucosal lining fluid at the various sampling time points can be detected and if prior BCG vaccination leads to more severe local or systemic reactions after COVID-19 vaccination.
    Secundaire doelen zijn om te bepalen of antilichaam concentraties tegen SARS-CoV-2 antigenen in slijmvlies van de neus op verschillende tijdspunten gedetecteerd kunnen worden en of er in de BCG-groep na COVID-19 heftigere locale of systemische bijwerkingen optreden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age equal to or above 18 years;
    - Written informed consent provided by the participant;
    - Receiving BioNTech/Pfizer COVID-19 vaccine per routine care;
    - Having received BCG-vaccination in the past 12 months OR never having received BCG-vaccination.
    - Leeftijd ouder dan of gelijk aan 18 jaar.
    - Schriftelijke toestemming voor deelname;
    - Wordt via de reguliere zorg met het BioNTech/Pfizer COVID-19 vaccin gevaccineerd;
    - In de afgelopen 12 maanden gevaccineerd met BCG OF nooit een BCG vaccinatie gehad.
    E.4Principal exclusion criteria
    - Legally incapacitated or unwilling to provide informed consent;
    - History of COVID-19 infection, confirmed by a microbiological test.
    - Juridisch handelingsonbekwaam of geen schriftelijke toestemming willen geven;
    - Doorgemaakte COVID-19 infectie, bewezen met een microbiologische test.
    E.5 End points
    E.5.1Primary end point(s)
    Seroconversion of IgG to the SARS-CoV-2 spike protein at day 21 after the first dose of Pfizer/BioNTech BNT162B2. Seroconversion of antibodies is defined as a change from seronegative at baseline (pre-1st dose of Pfizer/BioNTech BNT162B2) to seropositive or a ≥four-fold titer increase if the participant is seropositive at baseline
    Seroconversie van IgG naar SARS-CoV-2 spike eiwit op dag 21 na de eerste injectie van het Pfizer/BioNTech BNT162B2 vaccin. Seroconversie van de antilichamen is gedefineerd als verandering van seronegatief bij aanvang/baseline (vóór de eerste injectie van het Pfizer/BioNTech BNT162B2 vaccin) naar seropositief of een viervoud verhoogde stijging van titer als de deelnemer bij aanvang/baseline seropositief was.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be analyzed when all blood samples of timepoint Day 21 have been collected.
    De primaire uitkomstmaat zal geanalyseerd worden zodra alle bloed samples van tijdspunt Dag 21 zijn verzameld.
    E.5.2Secondary end point(s)
    - Geometric mean concentrations (GMCs) of RBD- and S-specific IgG, IgA and IgM in serum at day 21, 35, month 6 and 12;
    - IgG, IgA and IgM concentrations against SARS-CoV-2 antigens in nasal mucosal lining fluid at the various sampling time points;
    - Local reactions at injection site or systemic reactions after COVID-19 vaccination;
    - T-cell responses and monocyte cytokine response to ex vivo stimulation at the various time points.
    - Geometrische gemiddelde concentratie van receptor-bindend domein (RBD-) en S-specifieke IgG, IgA en IGM antilichamen in het serum op dag 21, 35, na 6 maanden en na 12 maanden;
    - IgG, IgA en IgM concentraties tegen SARS-CoV-2 antigenen in slijmvlies van de neus op verschillende tijdspunten;
    - Lokale of systemische reacties na COVID-19 vaccinatie.
    - T-cel reactie en monocyt cytokine reactie na ex vivo stimulatie op verschillende tijdspunten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary analyses will need data from follow-up of the study and will be performed at the end of the study.
    Voor de analyse van de secundaire eindpunten is follow-up data nodig en zij zullen na afloop van de studie geanalyseerd worden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Nooit BCG vaccinatie gehad
    Never received BCG vaccination
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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
    The study ends after the last blood collection. This is time point 4, one year after the first injection of the COVID-19 vaccine.
    De studie eindigt een jaar na de laatste bloedverzameling. Dat is tijdstip 4, een jaar na de eerste injectie van het COVID-19 vaccin.
    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 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: 40
    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 No
    F.3.3Specific vulnerable populations No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2021-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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