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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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:2021-002014-14
    Sponsor's Protocol Code Number:COV-PBO-MO28
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-16
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-002014-14
    A.3Full title of the trial
    Antibody and cellular response 28 days after the first dose of COVID-19 vaccine (Moderna) and then 33 weeks after the second dose and 8-12 weeks after the third dose in clinically stable patients with functional kidney transplantation.
    Protilátková a buněčná odpověď v odstupu 28 dní po podání první dávky COVID-19 vakcíny (Moderna) a následně v odstupu 33 týdnů od podání druhé dávky a po 8-12 týdnech od podání třetí dávky vakcíny u klinicky stabilních pacientů s funkční transplantovanou ledvinou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibody and cellular response 28 days after the first dose of COVID-19 vaccine (Moderna) and then 33 weeks after the second dose and 8-12 weeks after the third dose in clinically stable patients with functional kidney transplantation.
    Protilátková a buněčná odpověď v odstupu 28 dní po podání první dávky COVID-19 vakcíny (Moderna) a následně v odstupu 33 týdnů od podání druhé dávky a po 8-12 týdnech od podání třetí dávky vakcíny u klinicky stabilních pacientů s funkční transplantovanou ledvinou.
    A.4.1Sponsor's protocol code numberCOV-PBO-MO28
    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 SponsorFakultní nemocnice Hradec Králové
    B.1.3.4CountryCzechia
    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 supportHemodialyzační středisko Fakultní nemocnice Hradec Králové
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice Hradec Králové
    B.5.2Functional name of contact pointOddělení klinických hodnocení
    B.5.3 Address:
    B.5.3.1Street AddressSokolská 581
    B.5.3.2Town/ cityHradec Králové
    B.5.3.3Post code50005
    B.5.3.4CountryCzechia
    B.5.4Telephone number00420727833725
    B.5.6E-mailkarolina.mullerova@fnhk.cz
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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 AuthorisationCzechia
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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) No
    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.IMP: 2
    D.1.2 and D.1.3IMP Role
    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 AuthorisationCzechia
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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) No
    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
    Antibody and cellular response 28 days after the first dose of COVID-19 vaccine (Moderna) and then 33 weeks after the second dose and 8-12 weeks after the third dose in clinically stable patients with functional kidney transplantation.
    Protilátková a buněčná odpověď v odstupu 28 dní po podání první dávky COVID-19 vakcíny (Moderna) a následně v odstupu 33 týdnů od podání druhé dávky a po 8-12 týdnech od podání třetí dávky vakcíny u klinicky stabilních pacientů s funkční transplantovanou ledvinou.
    E.1.1.1Medical condition in easily understood language
    Antibody and cellular response 28 days after the first dose of vaccine and then 33 weeks after the second dose and 8-12 weeks after the third dose in patients with functional kidney transplantation.
    Protilátková a buněčná odpověď v odstupu 28 dní po podání 1. dávky vakcíny a následně v odstupu 33 týdnů od podání 2. dávky a po 8-12 týdnech od podání 3. dávky u pacientů s transplantovanou ledvinou.
    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
    1. To describe the antibody and cellular response in clinically stable patients after successful kidney transplantation 33 weeks after the second dose of the registered mRNA-vaccine against COVID-19 disease (Spikevax vaccine, Moderna), ie on the day of the third dose of vaccine.
    2. To describe the antibody and cellular response in the same group of clinically stable patients after successful kidney transplantation 8-12 weeks after this third vaccination dose.
    1. Popsat protilátkovou a buněčnou odpověď u klinicky stabilních pacientů po úspěšné transplantaci ledviny v odstupu 33 týdnů od aplikace druhé dávky registrované mRNA-vakcíny proti COVID-19 onemocnění (vakcína Spikevax, Moderna), tj. v den podání třetí dávky vakcíny.
    2. Popsat protilátkovou a buněčnou odpověď u téhož souboru klinicky stabilních pacientů po úspěšné transplantaci ledviny za 8-12 týdnů po této třetí vakcinační dávce
    E.2.2Secondary objectives of the trial
    1. To evaluate the clinical course in the interval between the 2nd and 3rd dose of the Moderna vaccine in terms of the incidence of de-novo disease COVID-19, to use the given IgG antibodies for evaluation.
    2. Evaluate the clinical course in the interval between the 3rd dose and control collection in the range of 8-12 weeks after its administration, verify the tolerance of the vaccine and analyze other routinely monitored clinical and laboratory parameters, including pharmacotherapy, for antibody and cellular response to the vaccine.
    3. Distinguish the antibody response elicited by a possible asymptomatic SARS-Cov-2 infection from the vaccine-induced antibody response (simultaneous examination of two different IgG proteins, detection of antibodies against spike protein after vaccination vs detection of NP-protein after disease).
    1. Vyhodnotit klinický průběh v intervalu mezi 2. a 3. dávkou vakcíny Moderna z hlediska výskytu de-novo onemocnění COVID-19, k vyhodnocení využít i dané IgG protilátky.
    2. Vyhodnotit klinický průběh v intervalu mezi 3. dávkou a kontrolním odběrem v rozmezí 8-12 týdnů po jejím podání, ověřit toleranci vakcíny a analyzovat další rutinně sledované klinické i laboratorní parametry, včetně farmakoterapie, k protilátkové i buněčné odpovědi na vakcínu.
    3. Odlišit protilátkovou odpověď vyvolanou případnou asymptomatickou infekcí virem SARS-Cov-2 od protilátkové odpovědi navozené vakcínou (souběžné vyšetření dvou rozdílných IgG proteinů, detekce protilátek proti „spike“ proteinu po očkování vs detekce NP-proteinu po prodělané nemoci).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age 20 ≥ 75 years
    2. the ability to understand the nature and course of the study and to agree in writing to the study by signing Informed Consent
    3. Day 28 after dosing Moderna
    4. with a functional kidney transplant
    5. with stable function of the transplanted kidney (graft)
    6. more than 3 months after kidney transplantation
    7. no change in immunosuppressive therapy and / or no infection since the Moderna dose was given
    1. věk 20 ≥ 75 let
    2. schopnost porozumět podstatě a průběhu studie a písemně vyjádřit souhlas se studií podpisem Informovaného souhlasu
    3. 28. den po aplikaci dávky vakcíny Moderna
    4. s funkční transplantovanou ledvinou
    5. se stabilní funkcí transplantované ledviny (štěpu)
    6. více než 3 měsíce po transplantaci ledviny
    7. beze změny imunosupresivní léčby a/nebo bez infekce v období od podání dávky vakcíny Moderna
    E.4Principal exclusion criteria
    1. insufficient venous system in the upper limbs with the risk of having repeated intravenous injections to obtain a blood sample
    2. past COVID-19 disease
    3. concurrent participation in another clinical trial
    4. pregnancy, breastfeeding
    1. insuficientní žilní systém na horních končetinách s rizikem nutnosti opakovaných vpichů do žíly k získání vzorku krve
    2. prodělané onemocnění COVID-19
    3. souběžná účast v jiném klinickém hodnocení
    4. gravidita, kojení
    E.5 End points
    E.5.1Primary end point(s)
    To describe the antibody and cellular response in clinically stable patients after successful kidney transplantation 33 weeks after the second dose of the registered mRNA-vaccine against COVID-19 disease (Spikevax vaccine, Moderna), ie on the day of the third dose of vaccine.
    Popsat protilátkovou a buněčnou odpověď u klinicky stabilních pacientů po úspěšné transplantaci ledviny v odstupu 33 týdnů od aplikace druhé dávky registrované mRNA-vakcíny proti COVID-19 onemocnění (vakcína Spikevax, Moderna), tj. v den podání třetí dávky vakcíny.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all blood samples collections.
    Po odběru všech vzorků krve.
    E.5.2Secondary end point(s)
    To describe the antibody and cellular response in the same group of clinically stable patients after successful kidney transplantation 8-12 weeks after this third vaccination dose.
    Popsat protilátkovou a buněčnou odpověď u téhož souboru klinicky stabilních pacientů po úspěšné transplantaci ledviny za 8-12 týdnů po této třetí vakcinační dávce.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days after the first dose of COVID-19 vaccine (Moderna) and 33 weeks after the second dose and 8-12 weeks after the third dose in clinically stable patients with functional kidney transplantation.
    V odstupu 28 dní po podání první dávky COVID-19 vakcíny (Moderna) a následně v odstupu 33 týdnů od podání druhé dávky a po 8-12 týdnech od podání třetí dávky vakcíny u klinicky stabilních pacientů s funkční transplantovanou ledvinou.
    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 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
    Completion of the study visit (End of trial visit) at the last patient, ie 8 - 12 weeks after the third dose of vaccine.
    Ukončení studijní návštěvy (Výstupní návštěva) u posledního pacienta, tedy 8 - 12 týdnů po třetí dávce vakcíny.
    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 months10
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days15
    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: 30
    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 No
    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 state60
    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.
    Žádná.
    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 Decision2021-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-24
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