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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44063   clinical trials with a EudraCT protocol, of which   7319   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:2021-004889-35
    Sponsor's Protocol Code Number:UCDCRC/21/10
    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:2022-05-19
    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 number2021-004889-35
    A.3Full title of the trial
    An International Multicentre, Phase 2, Randomised, Adaptive Protocol to determine the need for, optimal timing of and immunogenicity of administering a 4th homologous mRNA vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated against SARS-CoV-2
    (EU-COVAT-2 BOOSTAVAC)
    Protocolo internacional multicéntrico, de fase 2, aleatorizado y adaptativo para determinar la necesidad, el momento óptimo y la inmunogenicidad de administrar una cuarta dosis de vacunación homóloga de ARNm contra el SARS-CoV-2 en la población general (18+ años) ya vacunados contra el SARS-CoV-2 (EU-COVAT-2 BOOSTAVAC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a multicentre Phase II trial evaluating different booster strategies in individuals already vaccinated against SARS-CoV-2. This trial allows testing of different booster strategies for comparative assessment of their immune responses and safety against SARS-CoV-2 and its variants. This study tests whether a 4th vaccination dose is needed and determines the optimal booster vaccination schedule for further evaluation in a phase III trial.
    Se trata de un ensayo multicéntrico de fase II que evalúa diferentes estrategias de refuerzo en personas ya vacunadas contra el SARS-CoV-2. Este ensayo permite probar diferentes estrategias de refuerzo para la evaluación comparativa de sus respuestas inmunitarias y seguridad contra el SARS-CoV-2 y sus variantes. Este estudio prueba si se necesita una cuarta dosis de vacunación y determina el programa óptimo de vacunación de refuerzo para una evaluación adicional en un ensayo de fase III.
    A.3.2Name or abbreviated title of the trial where available
    EU-COVAT-2 BOOSTAVAC
    EU-COVAT-2 BOOSTAVAC
    A.4.1Sponsor's protocol code numberUCDCRC/21/10
    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 SponsorUniversity College Dublin
    B.1.3.4CountryIreland
    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 supportEU Horizon 2020 research and innovation funding framework
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación de Investigación Biomédica Hospital Universitario La Paz
    B.5.2Functional name of contact pointPaula Prieto Correa
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34689522262
    B.5.6E-mailpaulaprieto.ucicec@gmail.com
    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.3.4Pharmaceutical form Concentrate for dispersion for injection
    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 INNComirnaty
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    Severe Acute Respiratory Syndrome Coronavirus 19 (COVID-19/SARS-CoV-2)
    Síndrome Respiratorio Agudo Severo Coronavirus 19 (COVID-19/SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    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 23.1
    E.1.2Level PT
    E.1.2Classification code 10084457
    E.1.2Term COVID-19 immunisation
    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 10084462
    E.1.2Term SARS-CoV-2 vaccination
    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 determine the need for, optimal timing of, and immunogenicity of administering a 4th homologous vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated with the BNT162b2 vaccine.
    Determinar la necesidad, el momento óptimo y la inmunogenicidad de administrar una cuarta dosis homóloga de vacunación contra el SARS-CoV-2 en la población general (mayores de 18 años) ya vacunada con la vacuna BNT162b2
    E.2.2Secondary objectives of the trial
    • To determine the change in cellular immune response measured by a direct from blood qPCR based T-cell activation (dq-TACT) assay at 14 days after 4th dose vaccine in comparison to prior to 4th dose vaccination.
    • To correlate humoral immune response, cellular immune responses and viral neutralising capacity against wild type SARS-CoV-2
    • To determine the durability of humoral and cellular immune responses after 3rd dose of initial vaccination and 4th dose vaccination
    • To determine rates of, and maximum disease severity associated with confirmed SARS-CoV-2 infections occurring after enrolment in study participants before and after 4th dose vaccine
    • To explore primary and secondary endpoints stratified by incident infection pre-4th dose vaccine or by any modification of vaccine epitope.
     Determinar el cambio en la respuesta celular immune medido mediante un ensayo de activación de células T basado en qPCR (dq-TACT) 14 días después de la vacuna en comparación con antes de haber recibido la vacuna.
     Correlacionar la respuesta inmune humoral, las respuestas inmunes celulares y la capacidad de neutralización viral contra la cepa inicial de SARS-CoV-2.
     Determinar la durabilidad de las respuestas inmunitarias humoral y celular después de la 3ª dosis de la vacuna y respuestas a corto plazo a la 4ª dosis de la vacuna.
     Determinar las tasas y la gravedad máxima de las enfermedades asociadas con las infecciones confirmadas por SARS-CoV-2 que ocurren tras la inclusión de participantes en el estudio, antes y después de haber recibido la cuarta dosis de la vacuna
     Explorar las variables primarias y secundarias estratificadas por infección incidente antes de la cuarta dosis de la vacuna o por cualquier modificación del epítopo de la vacuna
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults aged 18 years or above at baseline
    • Be at least three but no more than 6 months (+/- 4 weeks) from the date of 3rd dose of BNT162b2 vaccine at the time of consent
    • Have received three homologous doses as primary vaccination against SARS-CoV-2 with BNT162b2 vaccine (vaccination status should be documented).
    • Written informed consent from the subject has been obtained.
     Adultos de 18 años o más al inicio del estudio
     Que hayan pasado al menos 3 meses pero no más de 6 meses (+/- 4 semanas) desde que recibieron la 3ª dosis de la vacuna BNT162b2
     Haber recibido tres dosis homólogas como vacunación primaria frente al SARS-CoV-2 con la vacuna BNT162b2 (se debe documentar el estado de vacunación).
     Obtención del consentimiento informado por escrito del sujeto
    E.4Principal exclusion criteria
    • Unable to provide written, informed consent
    • Participation in any other interventional trials
    • People who have already received a booster vaccination
    • Any significant or uncontrolled disease posing a risk with vaccination as judged by the investigator
    • Any significant medical condition that in the opinion of the investigator would necessitate booster vaccination against SARS-CoV-2 within the trial timelines
    • Any kind of dependency on the sponsor or principal investigator or employed by the sponsor or principal investigator
    • Where a subject’s primary vaccination and third dose vaccination was not with the BNT162b2 mRNA vaccine
    • Any contraindication to the vaccines in the trial as per the Summary of Medicinal Product Characteristics, SmPC) or the Investigator’s Brochure, if appropriate.
    • Use of drugs with significant interaction with the investigational product
    • Subjects who are pregnant and who are planning to become pregnant
    • Nursing mothers
    • Unwillingness to use highly effective contraceptive methods.
     Incapaz de proporcionar el consentimiento informado por escrito
     Participación en cualquier otro ensayo de intervención
     Personas que ya hayan recibido la cuarta dosis de la vacuna contra el SARS-CoV-2
     Cualquier enfermedad significativa o no controlada que represente un riesgo con la vacuncación a juicio del investigador
     Cualquier condición médica importante que, en opinion del investigador, requiera una vacunación de refuerzo contra el SARS-CoV-2 dentro de los plazos del ensayo.
     Cualquier tipo de relación de dependencia entre el participante con el promotor o investigador principal o que el participante sea un empleado directo del promotor o del investigador principal.
     Que la vacunación primaria y la tercera dosis recibidas no hayan sido con la vacuna de ARNm BNT162b2
     Cualquier contraindicación a las vacunas del ensayo según la ficha técnica del medicamento
     Uso de fármacos con interacción significativa con el producto en investigación
     Mujeres embarazadas o que planean quedarse embarazadas durante el transcurso del estudio
     Mujeres en estado lactante
     Mujeres en edad fértil (es decir, que no son posmenopáusicas) y que no se comprometen a usar métodos anticonceptivos altamente efectivos
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to ≥500 IU/mL at day 14 post 4th dose booster vaccine in those with anti-RBD antibody titre of ≤500 IU/mL immediately before 4th dose booster vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following 4th dose vaccination in those with anti-RBD titre of ≥500 IU/mL immediately before 4th dose booster vaccination, as measured by quantitative immunoassay targeting the anti-RBD antibody.
    La variable principal del estudio es una variable compuesta de un aumento en el título de anticuerpos RBD a ≥500 IU/mL en el día 14 tras haber recibido la 4ª dosis de la vacuna en aquellos con un título de anticuerpos RBD de ≤500 IU/mL inmediatamente antes de la 4ª dosis de la vacuna, o un aumento de 2 veces en el título de anticuerpos RBD en el día 14 después de recibir la 4ª dosis de la vacuna en aquellos con título RBD de ≥500 IU/mL inmediatamente antes de recibir la 4ª dosis de la vacuna, medido por inmunoensayo dirigido al anticuerpo RBD
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after 4th dose vaccine
    14 días después de haber recibido la 4ta dosis de la vacuna
    E.5.2Secondary end point(s)
    • The proportion of subjects reporting positive tests (PCR and/or antigen tests) for SARS-CoV-2 at each reporting time point after enrolment
    • The proportion of subjects who receive 4th dose vaccination at each specific timepoint that achieve a 2-fold increase in RBD antibody titre 14 days after the 4th dose vaccine
    • The proportion of subjects who receive 4th dose vaccination at each specific timepoint that achieve an anti-RBD antibody titre ≥500 IU/mL 14 days after the 4th dose vaccine
    • Rate of 2-fold RBD antibody titre increase following 4th dose vaccination measured by quantitative immunoassay targeting the spike 1 (S1) and nucleocapsid (NC) antibodies at 14 days after 4th dose vaccine as compared to immediately before vaccination
    • Analysis stratified by incident pre-4th dose SARS-CoV-2 infections and any modification of vaccine epitope

    Safety/tolerability:
    • Solicited AEs for 7 days after 4th dose
    • Unsolicited/Spontaneous AEs until the end of trial
    • Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria until up to three months after 4th dose or subject completes the study, whichever occurs first.

    Laboratory:
    • T-cell activation as measured by a whole blood dq-TACT assay before and 14 days after 4th dose vaccine
    • Neutralising activity against SARS-CoV-2 wild-type and variants of concern as measured by a standardised viral neutralisation assay (sub-group analysis)

    Exploratory endpoints:
    • Detailed immunophenotyping of immune responses, including metabolomics, proteomics and transcriptomics where relevant (sub-group analysis)
    • Whole genome sequencing of isolated SARS-CoV-2 viral strains detected in breakthrough infections
    • Haemagglutination assay as a surrogate of neutralising capacity
     La proporción de sujetos que comunicaron pruebas positivas (PCR y/o pruebas de antígenos) para SARS-CoV-2 en las visitas del estudio tras la inclusión
     La proporción de sujetos que reciben la vacuna de la cuarta dosis en cada punto de tiempo específico y que logran un aumento del doble en el título de anticuerpos RBD 14 días después de la vacuna de la cuarta dosis
     La proporción de sujetos que reciben la vacuna de la cuarta dosis en cada momento específico y que alcanzan un título de anticuerpos RBD ≥500 UI/mL 14 días después de la vacuna de la cuarta dosis
     Tasa de aumento de dos veces en el título de anticuerpos RBD después de la vacunación con la cuarta dosis medida mediante inmunoensayo cuantitativo dirigido a los anticuerpos del pico 1 (S1) y de la nucleocápside (NC) 14 días después de la vacuna con la cuarta dosis en comparación con inmediatamente antes de la vacunación
     Análisis estratificado por infecciones incidentes antes de la cuarta dosis de SARS - CoV-2 y cualquier modificación del epítopo de la vacuna

    Seguridad/tolerabilidad:
     AA solicitados durante 7 días después de la 4ª dosis
     AA no solicitados/espontáneos hasta el final del estudio
     Tasa de eventos adversos graves (AAG) Grado ≥3 según los Criterios comunes de toxicidad del Instituto Nacional del Cáncer hasta tres meses después de la cuarta dosis o hasta que el sujeto complete el estudio, lo que ocurra primero

    Laboratorio:
     Activación de células T medido por un ensayo dq-TACT de sangre entera antes y 14 días después de la vacuna de la cuarta dosis
     Actividad neutralizante contra la cepa inicial de SARS-CoV-2 y variantes de interés según lo medido por un ensayo de neutralización viral estandarizado (análisis de subgrupos)

    Variables exploratorias:
     Inmunofenotipificación detallada de las respuestas inmunitarias, incluida la metabolómica, la proteómica y la transcriptómica de muestras de sangre y saliva cuando sea pertinente (análisis de subgrupos)
     Secuenciación del genoma completo de cepas virales de SARS-CoV-2 aisladas detectadas en infecciones emergentes
     Ensayo de hemaglutinación como sustituto de la capacidad neutralizante
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 and 14 days after 4th dose vaccine
    a los 7 y los 14 días tras haber recibido la 4ta dosis de la vacuna
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    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
    El grupo de control será ofrecido la 4ta dosis de la vacuna (19 meses después)
    Control group offered 4th dose vaccine at the end of the study(19 months after initial vaccination)
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Sweden
    Netherlands
    Spain
    Switzerland
    Germany
    Belgium
    Denmark
    Ireland
    Norway
    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
    Ultima visita del ultimo paciente
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 500
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation VACCELERATE
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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