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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2004-001525-21
    Sponsor's Protocol Code Number:MANON-02
    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:2005-05-19
    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 number2004-001525-21
    A.3Full title of the trial
    Estudio clínico controlado con placebo, aleatorizado, de fase II, para evaluar la inmunogenicidad y la toxicidad de dos patrones de inducción-refuerzo complementarios con el ALVAC-VIH vCP1452 en pacientes con infección crónica del VIH
    A.4.1Sponsor's protocol code numberMANON-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorORVACS, Objectif Recherche Vaccin SIDA
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameALVAC(2)HIV (vCP1452)
    D.3.2Product code ALVAC(2)120(B,MN)GNP (vCP1452)
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 placeboPowder for injection*
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infección por el VIH
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10008919
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la inmunogenicidad de dos patrones de inmunización con vCP1452 para incrementar la frecuencia de células mononucleares sanguíneas periféricas (CMSP) específicas del VIH entre la línea base y 4 semanas después de la última inyección (S24).
    E.2.2Secondary objectives of the trial
    - Determinar el porcentaje de pacientes con un incremento en la frecuencia de CMSP específicas del VIH y/o células T CD4 y/o CD8 de como mínimo un 0,7 log10 de la línea base en comparación con las S4, S6, S8, S12, S20 y S24 en las ramas estudio- Evaluar la magnitud y la cinética de las respuestas inmunitarias de los CD4 y CD8 generadas por el patrón de inmunización en los tres grupos y por los tres métodos (LPA, ELISpot, ICC)- Evaluar la capacidad de los patrones de inmunización para alargar el periodo sin terapia ARV tras la supresión en la S24- Evaluar la durabilidad de las respuestas inmunitarias inducidas por la inmunización con vCP1452 hasta la S48 (24 semanas después de la supresión del tratamiento antirretroviral)- Evaluar el porcentaje de pacientes que generan una respuesta inmunitaria primaria contra las secuencias artificiales pol/nef presentes en la vacuna pero no en la cepa de VIH
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Pacientes con infección crónica del VIH:- con terapia antirretroviral potente durante más de 6 meses - con recuentos de CD4+ iniciales > 350 cél./mm3 durante al menos 1 año - ARN plasmático del VIH < 400 cop./ml durante al menos los últimos 6 meses.
    E.4Principal exclusion criteria
    - Cualquier acontecimiento infeccioso agudo en los 30 días previos al inicio del estudio- Pacientes tratados en el momento de la primoinfección por el VIH- Terapia antirretroviral iniciada con recuento de células CD4 > 400/mm³- Pacientes con infección crónica de Hepatitis C y/o Hepatitis B - Pacientes con algún acontecimiento definitorio de SIDA anterior- Pacientes que han participado en algún estudio de investigación de vacunas para el VIH - Pacientes que han participado en algún estudio clínico inmunomodulador (como IL2) o han recibido una corticoterapia sistémica en los últimos 6 meses- Pacientes que han recibido alguna inmunización distinta de la del VIH en el último mes- Pacientes que padezcan una afección grave que, en opinión del investigador, comprometería la seguridad del sujeto- Mujeres embarazadas o en periodo de lactancia- Pacientes que consumen actualmente alcohol o drogas ilegales que, en opinión del investigador, pueden interferir con la capacidad del sujeto para cumplir con el patrón de dosificación y las evaluaciones del protocolo- Alguna historia de anafilaxis o de otra reacción adversa grave a vacunas- Alergia a los ovoproductos o a la neomicina- Profesionales que trabajen en estrecho contacto con canarios y que puedan tener anticuerpos del canarypox (los individuos con un canario de mascota no quedan excluidos).
    E.5 End points
    E.5.1Primary end point(s)
    Variación de la línea base de la frecuencia de las CMSP específicas del VIH en la S24 (4 semanas después de la última inmunización)
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2005-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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