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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Summary
    EudraCT Number:2021-002356-37
    Sponsor's Protocol Code Number:VAX-TRES
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002356-37
    A.3Full title of the trial
    Study about the response to the administration of a third dose of mRNA-1273 vaccine (COVID19 vaccine Moderna) in renal transplants with immunological failure initial to vaccination
    ESTUDIO SOBRE LA RESPUESTA A LA ADMINISTRACIÓN DE UNA TERCERA DOSIS DE LA VACUNA mRNA-1273 (COVID19 Vaccine Moderna) EN TRASPLANTADOS RENALES CON FRACASO INMUNOLÓGICO INICIAL A LA VACUNACION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study about the response to the administration of a third dose of mRNA-1273 vaccine (COVID19 vaccine Moderna) in renal transplants with immunological failure initial to vaccination
    ESTUDIO SOBRE LA RESPUESTA A LA ADMINISTRACIÓN DE UNA TERCERA DOSIS DE LA VACUNA mRNA-1273 (COVID19 Vaccine Moderna) EN TRASPLANTADOS RENALES CON FRACASO INMUNOLÓGICO INICIAL A LA VACUNACION
    A.4.1Sponsor's protocol code numberVAX-TRES
    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 SponsorFundació Clinic per a la Recerca Biomèdica (FCRB)
    B.1.3.4CountrySpain
    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 supportFundació Clinic per a la Recerca Biomèdica (FCRB)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit - FCRB
    B.5.2Functional name of contact pointCTU Clinic
    B.5.3 Address:
    B.5.3.1Street AddressCasanova, 150
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754004199
    B.5.5Fax number34932279877
    B.5.6E-mailjoyera@clinic.cat
    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 dispersion for injection
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOVID-19 mRNA vaccine
    D.3.9.2Current sponsor codeCOVID-19 mRNA vaccine
    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 ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) 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
    COVID19 vaccine in kidney transplant patients
    Vacuna COVID19 en pacientes trasplantados renales
    E.1.1.1Medical condition in easily understood language
    COVID19 vaccine in kidney transplant patients
    Vacuna COVID19 en pacientes trasplantados renales
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 100000004865
    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 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective will be to analyze the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen.
    El objetivo será el de analizar el desarrollo de inmunidad celular y humoral frente a SARS-CoV-2 tras la administración de una tercera dosis de la vacuna mRNA-1273 (Moderna) en pacientes que han permanecido seronegativos tras la pauta estándar completa (dos dosis).
    E.2.2Secondary objectives of the trial
    - To analyse the development of cellular and humoral immunity against SARS-CoV-2 after 4 months of administration of a third dose of mRNA-1273 vaccine (Moderna).
    - To establish baseline factors associated with biological non-response to vaccination.
    - To assess the safety and tolerability of the administration of the third dose of mRNA-1273 (Moderna) vaccine.
    •Analizar el desarrollo de inmunidad celular y humoral frente a SARS-CoV-2 tras 4 meses de la administración de una tercera dosis de la vacuna mRNA-1273 (Moderna).
    •Establecer factores basales asociados a la no respuesta biológica a la vacunación.
    •Evaluar la seguridad y tolerabilidad de la administración de la tercera dosis de la vacuna mRNA-1273 (Moderna).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 years;
    2. Male or female sex;
    3. Renal transplant with stable renal function in the last 2 months prior to study inclusion;
    4.Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose.
    5.Patient giving written informed consent.
    1.Edad > 18 años;
    2.Sexo masculino o femenino;
    3.Trasplante renal con función renal estable en los últimos 2 meses previamente a la inclusión en el estudio;
    4.Haber recibido pauta completa de vacunación para SARS-CoV-2 con la vacuna mRNA1273 (Moderna) y haber permanecido seronegativos a las 2 semanas después de la segunda dosis.
    5.Paciente que otorgue el consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. Renal transplantation < 3 months;
    2. Pregnancy or lactation status;
    3. Rejection treated within the last 6 months;
    4. Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
    1.Trasplante renal < 3 meses;
    2.Estado de embarazo o lactancia;
    3.Rechazo tratado en los últimos 6 meses;
    4.Presencia de inmunidad humoral frente al SARS-CoV-2 definida como presencia de IgM/IgG específicas.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to assess biological effectiveness by:
    - Total antibody and IgG before (day 0) and after administration of the third dose (week +2).
    - ELISpot of T-cells subjected to SARS-CoV-2 antigenic stimulus before (day 0) and after administration of the third dose (week +2)
    La variable principal del estudio es evaluar la efectividad biológica mediante:
    •Título anticuerpos totales e IgG antes (día 0) y después de la administración de la tercera dosis (semana +2).
    •ELISpot de células T sometidas a estímulo antigénicos de SARS-CoV-2 antes (día 0) y después de la administración de la tercera dosis (semana +2);
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 0 and week +2
    Día 0 y semana +2
    E.5.2Secondary end point(s)
    - Total antibody and IgG at 4 months after the third dose.
    - ELISpot of T-cells subjected to SARS-CoV-2 antigenic stimulus at 4 months after receiving the third dose.
    - Analysis of baseline factors associated with biological non-response to vaccination, including demographics, comorbidities, and transplant-associated factors:
    age, sex, diabetes, type of transplant (kidney-pancreas versus kidney), treatment with anti-thymocyte globulins (ATG) during the last year, lymphopenia defined as < 1000/mm3, time from transplantation < 1 year, eGFR (CKD-EPI), baseline immunosuppression, according to individual drug or the combination received by the patient, type of donor, BMI, ethnicity and blood type.
    - Percentage of patients with mild and/or severe adverse events after administration of the third dose.
    •Título anticuerpos totales e IgG a los 4 meses tras recibir la tercera dosis.
    •ELISpot de células T sometidas a estímulo antigénicos de SARS-CoV-2 a los 4 meses tras recibir la tercera dosis.
    •Análisis de los factores basales asociados a la no respuesta biológica a la vacunación, incluyendo factores demográficos, comorbilidades, y asociados al trasplante:
    Sexo
    Tipo de trasplante (renal / renopancreático)
    Tratamiento con globulinas antitimocíticas durante el último año
    Limfopenia definida como < 1000/mm3
    Tiempo del trasplante < 1 año
    eGFR (CKD-EPI)
    inmunosupresion basal de acuerdo al tratamiento recibido por el paciente, tipo de donante, BMI, etnia y grupo sanguineo.
    •Porcentaje de pacientes que presentan acontecimientos adversos leves y/o graves tras la administración de la tercera dosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 months
    4 meses
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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
    LVLS
    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 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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 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 state80
    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
    Ninguno
    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 Decision2021-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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