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    Summary
    EudraCT Number:2021-001411-82
    Sponsor's Protocol Code Number:HIPRA-HH-1
    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:2021-06-22
    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 number2021-001411-82
    A.3Full title of the trial
    A phase I/IIa study to evaluate safety and immunogenicity of recombinant protein RBD fusion dimer candidate vaccine against SARS-CoV-2 in adult healthy volunteers.
    Estudio de fase I/IIa para evaluar la seguridad e inmunogenicidad de una vacuna candidata de proteína recombinante dimérica de fusión (RBD) frente al SARS-CoV-2 en voluntarios sanos adultos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I study to evaluate safety and immunogenicity of recombinant protein candidate vaccine against SARS-CoV-2 in healthy volunteers.
    Estudio de fase I para evaluar la seguridad e inmunogenicidad de una vacuna candidata de proteína recombinante frente al SARS-CoV-2 en voluntarios sanos.
    A.4.1Sponsor's protocol code numberHIPRA-HH-1
    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 SponsorLABORATORIOS HIPRA, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentro para el Desarrollo Tecnológico Industrial
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATORIOS HIPRA, S.A.
    B.5.2Functional name of contact pointR&D and Regulatory Affairs Director
    B.5.3 Address:
    B.5.3.1Street AddressAvda La Selva, 135
    B.5.3.2Town/ cityAmer, Girona
    B.5.3.3Post code17170
    B.5.3.4CountrySpain
    B.5.4Telephone number+34972430660
    B.5.5Fax number+34972430661
    B.5.6E-mailelia.torroella@hipra.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 No
    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 namePHH-1V
    D.3.4Pharmaceutical form Emulsion 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 INNPHH-1V
    D.3.9.3Other descriptive namePHH-1V
    D.3.9.4EV Substance CodeSUB223972
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 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 INNBNT162b2SA
    D.3.9.3Other descriptive nameBNT162b2SA
    D.3.9.4EV Substance CodeSUB222038
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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
    SARS-CoV-2
    SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infección por COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers. Safety will be measured by solicited and unsolicited reactions (local and systemic) following each dose vaccination.
    Evaluar la seguridad y la tolerabilidad de la vacuna COVID-19 HIPRA en voluntarios sanos adultos. La seguridad se medirá mediante reacciones solicitadas y no solicitadas (locales y sistémicas) después de cada dosis de vacunación.
    E.2.2Secondary objectives of the trial
    1.Overall safety of COVID-19 HIPRA vaccine.
    2.Immunogenicity measured by wild-type and pseudovirus neutralization at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine.
    3.Immunogenicity measured by wild-type and pseudovirus neutralization at long-term, i.e. 24 and 48 weeks after the second dose of vaccine.
    4.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine.
    5.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at long-term, i.e. 24 and 48 weeks after the second dose of vaccine.
    6.T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine.
    7.Th-1/Th-2 T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine.
    1.Seguridad global de la vacuna de COVID-19 HIPRA
    2.Inmunogenicidad medida por neutralización del pseudovirus y wild-type basal y a las 3 semanas posteriores de la 1era dosis y a las 2 semanas posteriores de la 2a dosis de la vacuna
    3.Inmunogenicidad medida por neutralización pseudovirus y wild-type a largo plazo (24 y 48 semanas posteriores a la 2a dosis de la vacuna)
    4.Inmunogenicidad medida por ELISA para la glucoproteína pico de SARS-CoV-2 al basal y a las 3 semanas posteriores a la 1era dosis y a las 2 semanas posteriores a la 2a dosis de la vacuna
    5.Inmunogenicidad medida por ELISA ligado a enzimas para la glicoproteína pico del SARS-CoV-2 a largo plazo (24 y 48 semanas posteriores a la 2a dosis de la vacuna)
    6.Respuestas mediadas de células T contra la glicoproteína SARS-CoV-2 S al basal y a las 2 semanas posteriores a la 2a dosis de la vacuna
    7.Respuestas Th-1/Th-2 contra la glicoproteína SARS-CoV-2 S al basal y a las 2 semanas posteriores a la 2a dosis de la vacuna
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults males or females between 18-39 years of age at the day of screening.
    2. Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
    3. Body Mass Index 18 to 40 Kg/m2 at screening.
    4. COVID19 negative PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination.
    5. Willing to avoid all other vaccines within 4 weeks before and after each injection. Seasonal influenza vaccination is allowed if it is received at least 14 days before or after the vaccination.
    6. Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.
    7. If female of childbearing potential, willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the last injection. Highly effective contraceptive methods will include: oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner and sexual abstinence.
    8. If male and not sterilized, willing to avoid impregnating female partners from screening until 18 weeks after last injection.
    9. Willing and able to provide written informed consent prior the initiation of any study procedures.
    1. Hombres o mujeres adultos entre 18-39 años de edad en el día del cribaje.
    2. Estar dispuestos y ser capaces de cumplir con las visitas programadas, pruebas de laboratorio, completar los diarios y otros procedimientos del estudio.
    3. Índice de Masa Corporal entre 18 y 40 Kg/m2 en el cribaje.
    4. Prueba de PCR negativa para COVID19 y PCR negativa de COVID19 y respuesta negativa de anticuerpos de unión IgG a la glicoproteína de SARS-CoV-2 en suero. S en la selección o antes de la primera vacunación.
    5. Estar dispuestos a evitar la administración de cualquier otra vacuna en las 4 semanas anteriores y posteriores a cada inyección. Se permite la vacunación contra la influenza estacional si se recibe al menos 14 días antes o posteriores a la vacunación.
    6. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en orina antes de la inclusión en el estudio y antes de cada vacunación.
    7. Si es mujer en edad fértil, debe estar dispuesta a utilizar métodos anticonceptivos altamente eficaces o practicar la abstinencia sexual desde el cribaje hasta 8 semanas posteriores a la última inyección. Los métodos anticonceptivos altamente eficaces incluirán: anticoncepción hormonal oral, intravaginal o transdérmica combinada (que contiene estrógeno y progestágeno) asociada con la inhibición de la ovulación; anticoncepción hormonal oral, inyectable o implantable de progestágeno sólo asociada con la inhibición de la ovulación; dispositivo intrauterino; sistema de liberación de hormonas intrauterinas; oclusión tubárica bilateral; pareja vasectomizada y abstinencia sexual.
    8. Si es hombre y no está esterilizado, debe estar dispuesto a evitar el embarazo de sus parejas femeninas desde la detección hasta 18 semanas posteriores a la última inyección.
    9. Dispuesto y capaz de proporcionar un consentimiento informado por escrito antes del inicio de cualquier procedimiento del estudio.
    E.4Principal exclusion criteria
    1. Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
    2. Positive pregnancy test at screening or prior to each vaccination.
    3. Any medical disease (acute, subacute, intermittent or chronic) or condition that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results.
    4. History of serious psychiatric condition likely to affect participation in the study (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
    5. History of respiratory disease (e.g., chronic obstructive pulmonary disease (COPD) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
    6. History of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
    7. History of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
    8. Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
    9. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.
    10. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
    NOTE: Mild psoriasis, well controlled autoimmune thyroid disease, vitiligo, stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy and any stable endocrine disorders that have a confirmed autoimmune aetiology (e.g., thyroid, pancreatic), including stable diet-controlled diabetes will be permitted at the discretion of the investigator.
    11. Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.
    12. Usage of any investigational drug ≤ 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination.
    13. History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.
    14. History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA (including the oil in water adjuvant equivalent to MF59).
    15. Use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination.
    NOTE: The use of topical, inhaled, and nasal routes are not permitted.
    16. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
    17. Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.
    18. Known bleeding disorder (e-g- factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
    NOTE: The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease.
    19. Chronic liver disease
    20. Positive test for HIV types 1 or 2 infection, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV Abs) at screening
    21. Suspected or known current alcohol abuse or any other substances abuse (except tobacco).
    22. History of COVID-19 infection.
    23. Receipt of medications intended to prevent COVID-19.
    24. Ever received an experimental vaccine against COVID-19.
    25. Close contact of anyone known to have SARS-CoV-2 infection within 15 days prior to screening visit.
    26. Being directly involved in the conduct of the stud
    27. Any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.
    1. Embarazo o en periodo de lactancia o deseo de embarazo o lactancia durante el periodo del estudio
    2. Prueba de embarazo positiva durante la visita de selección o antes de cada vacunación
    3. Cualquier enfermedad médica (aguda, subaguda, intermitente o crónica) o condición que en opinión del investigador comprometa la seguridad del voluntario, impida la vacunación o comprometa la interpretación de los resultados
    4. Historial de afección psiquiátrica grave que probablemente afecte la participación en el estudio (por ejemplo, depresión grave en curso, antecedentes de ingreso a un centro psiquiátrico para pacientes hospitalizados, ideas suicidas recientes, historial de intento de suicidio, trastorno bipolar, trastorno de la personalidad, dependencia del alcohol y las drogas, trastorno alimentario severo, psicosis, uso de estabilizadores del estado de ánimo o medicación antipsicótica)
    5. Antecedentes de enfermedad respiratoria (por ejemplo, enfermedad pulmonar obstructiva crónica (EPOC) y asma) que requieran cualquier medicación diaria en la actualidad o cualquier tratamiento de exacerbaciones de enfermedades respiratorias (por ejemplo, exacerbación del asma) en los últimos 5 años
    6. Historial de enfermedad cardiovascular significativa, incluida la hipertensión (por ejemplo, insuficiencia cardíaca congestiva, miocardiopatía, enfermedad cardíaca isquémica) o historia de miocarditis o pericarditis en la edad adulta
    7. Antecedentes de afecciones neurológicas o del neurodesarrollo (por ejemplo, migrañas, epilepsia, accidente cerebrovascular, convulsiones en los últimos 3 años, encefalopatía, déficits neurológicos focales, síndrome de Guillain-Barré, encefalomielitis o mielitis transversa)
    8. Malignidad continua o diagnóstico reciente de malignidad en los últimos cinco años, excluyendo el carcinoma de células basales y de células escamosas de la piel, que están permitidos
    9. Cualquier estado inmunosupresor o inmunodeficiente confirmado o sospecha, incluida la infección por VIH; asplenia; Infecciones graves recurrentes
    10. Cualquier enfermedad/condición autoinmune o inmunodeficiente (yatrogénica o congénita)
    11. Enfermedad aguda en las 72 h anteriores a cada vacunación que, en opinión del investigador, pueda interferir en la evaluación de los parámetros de seguridad
    12. Uso de cualquier medicamento en investigación ≤ 90 días antes del inicio o plan para participar en otra investigación que involucre un producto en investigación (medicamento/biológico/dispositivo) dentro de los 12 meses posteriores a la primera vacunación
    13. Historial de hipersensibilidad o reacción alérgica grave, incluida anafilaxia, urticaria generalizada, angioedema y otras reacciones importantes relacionadas con alimentos, fármacos, vacunas o agentes farmacéuticos.
    14. Historial de enfermedad alérgica o reacciones que probablemente se agraven con cualquier componente de la vacuna COVID-19 HIPRA (incluido el adyuvante de aceite en agua equivalente a MF59C.1).
    15. Uso de inmunosupresores, glucocorticoides u otros fármacos inmunomodificadores en los 2 meses anteriores a la1era vacunación; o necesidad de tratamiento inmunosupresor dentro de los 6 meses posteriores a la última vacunación
    16. Haber recibido inmunoglobulina, productos derivados de la sangre u otros medicamentos inmunosupresores dentro de los 90 días previos a la 1era vacunación
    17. Alteración conocida de la coagulación (iatrogénica o congénita) o discrasias sanguíneas
    18. Trastorno hemorrágico conocido (p.ej. deficiencia del factor, coagulopatía o trastorno plaquetario) o antecedentes de hemorragia significativa o hematomas después de inyecciones intramusculares o venopunción
    19. Enfermedad crónica del hígado
    20. Prueba + para infección por VIH de tipo 1 o 2, HBsAg o (Abs del VHC durante la selección
    21. Abuso actual de alcohol o bajo sospecha o abuso de cualquier otra sustancia (excepto tabaco)
    22. Historia de infección por COVID-19
    23. Haber recibido medicamentos para prevenir la COVID-19
    24. Haber recibido una vacuna experimental contra la COVID-19
    25. Contacto cercano con cualquier persona que con infección por SARS-CoV-2 dentro de los 15 días previos
    26. Estar directamente involucrado en la realización del estudio
    27. Cualquier condición y/o hallazgo de laboratorio que, a consideración del investigador, interfiera con el estudio o ponga en riesgo al participante
    E.5 End points
    E.5.1Primary end point(s)
    1.1 Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
    1.2 Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
    Local solicited reactions will be collected as pain, tenderness, erythema/redness, and induration/swelling.
    Systemic solicited events will be collected as fever, nausea/vomiting, diarrhoea, headache, fatigue and myalgia
    1.1 Número y porcentaje de acontecimientos adversos de reactogenicidad locales y sistémicos solicitados durante 7 días posteriores a cada vacunación.
    1.2 Número y porcentaje de acontecimientos adversos de reactogenicidad locales y sistémicos no solicitados durante los 28 días posteriores a cada vacunación.

    Las reacciones locales solicitadas se recopilarán como dolor, sensibilidad, eritema/enrojecimiento e induración/hinchazón.
    Los acontecimientos sistémicos solicitados se recopilarán como fiebre, náuseas/vómitos, diarrea, dolor de cabeza, fatiga y mialgia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 and 28 days
    7 y 28 días
    E.5.2Secondary end point(s)
    1.1 Change from baseline in safety laboratory parameters at 7 days following each vaccination.
    1.2 Number and percentage of serious adverse events throughout the study duration.
    1.3 Number and percentage of adverse events of special interest (AESI) throughout the study duration.
    1.4 Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration.
    2.1 Neutralization titer measured as Inhibitory concentration 50 (IC50) for each individual sample and geometric mean titer (GMT) for group comparison at Day 21 and 35. IC50 measured by a quantitative PRNT (plaque reduction neutralization test) and PBNA (pseudovirion-based neutralization assay).
    2.2 Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
    3.1 Neutralization titer measured as IC50 for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
    IC50 measured by a quantitative PRNT (plaque reduction neutralization test) and PBNA (pseudovirion-based neutralization assay).
    3.2 GMFR in neutralizing antibodies titers from baseline at 24 and 48 weeks after the second dose.
    4.1 Binding antibody IgG titer measured for each individual sample and GMT for group comparison at Day 21 and 35.
    4.2 GMFR in IgG titer from baseline at Day 21 and 35.
    5.1 Binding antibody IgG titer measured for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
    5.2 GMFR in IgG titer from baseline at 24 and 48 weeks after the second dose.
    6.1 T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole PBMC stimulation by ELISpot at baseline and at Day 35.
    7.1 CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at baseline and at Day 35.
    1.1 Cambio desde los niveles basales en los parámetros de laboratorio de seguridad a los 7 días posteriores a cada vacunación.
    1.2 Número y porcentaje de acontecimientos adversos graves durante la duración del estudio.
    1.3 Número y porcentaje de acontecimientos adversos de especial interés (AEI) durante la duración del estudio.
    1.4 Número y porcentaje de acontecimientos adversos con asistencia médica (AAM) relacionados con la vacuna en estudio durante la duración del estudio.
    2.1 Título de neutralización medido como concentración inhibitoria 50 (CI50) para cada muestra individual y media geométrica de los títulos (MGT) para la comparación de cohortes en los días 21 y 35. La CI50 se medirá mediante una PRNT cuantitativa (prueba de neutralización por reducción de placa) y PBNA (ensayo de neutralización basado en pseudovirion).
    2.2 Variación de la media geométrica de los títulos (GMFR) en los títulos de anticuerpos neutralizantes desde los niveles basales en los Días 21 y 35.
    3.1 Título de neutralización medido como CI50 para cada muestra individual y MGT para la comparación de cohortes a las 24 y 48 semanas posteriores a la segunda dosis. La CI50 se medirá mediante una PRNT cuantitativa (prueba de neutralización por reducción de placa) y PBNA (ensayo de neutralización basado en pseudovirion).
    3.2 GMFR en títulos de anticuerpos neutralizantes desde los niveles basales hasta las 24 y 48 semanas posteriores a la segunda dosis.
    4.1 Título de IgG de anticuerpos de unión para cada muestra individual y GMT para la comparación de cohortes en los días 21 y 35.
    4.2 GMFR en el título de IgG desde niveles basales hasta los días 21 y 35.
    5.1 Título de IgG de anticuerpos de unión para cada muestra individual y GMT para la comparación de cohortes a las semanas 24 y 48 posteriores a la segunda dosis.
    5.2 GMFR en el título de IgG desde los niveles basales hasta las semanas 24 y 48 posteriores a la segunda dosis.
    6.1 Respuesta mediada de células T a la proteína SARS-CoV-2 S medida por estimulación completa de PBMC por ELISpot a niveles basales del estudio y a los 35 días.
    7.1 Respuesta de células T CD4 +/CD8+ a la proteína SARS-CoV-2 S medida por estimulación de PBMC in vitro mediante ensayos de tinción de citoquinas a niveles basales y a los 35 días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 21, 28 and 35.
    24 and 48 weeks after the second dose.
    Días 21, 28 y 35.
    24 y 48 semanas después de la segunda dosis
    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 No
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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
    LVLS
    Última visita del último voluntario
    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 months14
    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: 30
    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 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 state30
    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 Decision2021-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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