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    Summary
    EudraCT Number:2022-001210-19
    Sponsor's Protocol Code Number:RCT-VCA-22
    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:2022-04-21
    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 number2022-001210-19
    A.3Full title of the trial
    Efficacy of the Vacucis Candida® autovaccine in the management of chronic oral candidiasis. Randomized triple-blind randomized clinical trial.
    Eficacia de la autovacuna Vacucis Candida® en el manejo de la candidiasis oral crónica. Ensayo clínico randomizado aleatorizado a triple ciego.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of an autovaccine in chronic oral candidiasis.
    Eficacia de una autovacuna en la candidiasis oral crónica.
    A.4.1Sponsor's protocol code numberRCT-VCA-22
    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 SponsorAbel García García
    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 supportGrupo ORALRES. Instituto de Investigación Sanitaria de Santiago de Compostela
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigación Sanitaria de Santiago de Compostela
    B.5.2Functional name of contact pointORALRESgroup (Alba Pérez González)
    B.5.3 Address:
    B.5.3.1Street AddressTravesía da Choupana s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number+34610527522
    B.5.6E-mailAlba.Perez.Gonzalez@sergas.es
    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 Vacucis Candida
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio Angulema 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.3.1Product nameVacucis candida
    D.3.4Pharmaceutical form Suspension and solution for spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCandida sppl
    D.3.9.3Other descriptive nameCandida sppl
    D.3.9.4EV Substance CodeSUB13223MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension and solution for spray
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic oral candidiasis
    Candidiasis oral crónica
    E.1.1.1Medical condition in easily understood language
    Candidiasis
    Candidiasis
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066492
    E.1.2Term Oral candidiasis recurrent
    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 evaluate the reduction/suppression of signs and symptoms of oral candidiasis in patients using Vacucis or Placebo.
    Evaluar la reducción/supresión de signos y síntomas de candidiasis oral en pacientes usuarios de Vacucis o Placebo.
    E.2.2Secondary objectives of the trial
    • Analyze the clinical symptoms of candidiasis in both trial groups.
    • Study the evolution of the clinical signs of candidiasis during the study
    • Microbiologically evaluation of the presence of candida throughout the duration of the study.
    • Analyze the relationship between clinical signs and symptoms in both trial groups and saliva levels
    • Analizar la sintomatología clínica de candidiasis en ambos grupos del ensayo
    • Estudiar la evolución de los signos clínicos de candidiasis durante el estudio
    • Evaluar microbiológicamente la presencia de cándidas durante toda la duración del estudio
    • Analizar la relación entre los signos y síntomas clínicos en ambos grupos del ensayo y los niveles de saliva
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients
    • Hemodynamically stable patients without contraindications to receive an autovaccine (see exclusion)
    • Patients with a stable oncological situation without active tumor
    • Patients who present candidiasis demonstrated by clinical examination (signs and symptoms of candidiasis) and microbiological (culture).
    • Pacientes mayores de edad
    • Pacientes hemodinámicamente estables y sin contraindicaciones para recibir una autovacuna (ver exclusión)
    • Pacientes con una situación oncológica estable sin tumor activo
    • Pacientes que presenten candidiasis demostrada mediante examen clínico (signos y síntomas de candidiasis) y microbiológico (cultivo).
    E.4Principal exclusion criteria
    • Patients <18
    • Pregnant patients
    • Patients with an unstable medical situation, both from a hemodynamic and oncological point of view (advanced tumors with metastases, recurrences or inoperable tumors)
    • Patients undergoing treatment with CT that involves an affectation of the immune system.
    • Patient being treated with antifungals for mycoses of any origin
    • Allergy to the active substance or to any of the other components of Vacucis.
    • Serious disorders of the immune system.
    • Diseases that severely affect immunity.
    • Presence of fever.
    • People with allergies to yeasts
    • People with an allergy to chloramphenicol
    • Patients treated with MAOIs (monoamine oxidase inhibitors)
    • Pacientes menores de edad
    • Pacientes embarazadas
    • Pacientes con situación médica inestable, tanto desde el punto de vista hemodinámico como oncológico (tumores avanzados con metástasis, recidivas o tumores inoperables)
    • Pacientes en tratamiento con QT que suponga una afectación del sistema inmunitario
    • Paciente en tratamiento con antifúngicos por micosis de cualquier origen
    • Alergia al principio activo o a alguno de los demás componentes de Vacucis.
    • Trastornos graves del sistema inmunológico.
    • Enfermedades que afecten de manera severa a la inmunidad.
    • Presencia de fiebre.
    • Personas con alergia a las levaduras
    • Personas con alergia al cloranfenicol
    • Pacientes tratados con IMAO (inhibidores de la monoaminooxidasa)
    E.5 End points
    E.5.1Primary end point(s)
    Prevalence and severity of candidiasis.
    Prevalencia y severidad de la candidiasis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, weekly for 7 weeks, at 3 months, and at 6 months.
    Al inicio, semanalmente durante 7 semanas, a los 3 meses y a los 6 meses.
    E.5.2Secondary end point(s)
    1) Cessation or reduction of candidiasis symptoms.
    2) Modification of fungal growth (CFU or colony-forming units) in culture plates.
    1) Cese o reducción de la clínica candidiásica.
    2) Modificación del crecimiento fúngico (UFC o unidades formadoras de colonias) en placas de cultivo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, weekly for 7 weeks, at 3 months, and at 6 months.
    Al inicio, semanalmente durante 7 semanas, a los 3 meses y a los 6 meses.
    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 No
    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) 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 No
    E.8.1.4Double blind Yes
    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 Yes
    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 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
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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 Decision2022-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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