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    Summary
    EudraCT Number:2016-002724-83
    Sponsor's Protocol Code Number:iHIVARNA-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-09
    Trial results View 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 number2016-002724-83
    A.3Full title of the trial
    A phase IIa randomized, placebo controlled, double blinded study to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy.
    Estudio de fase II, aleatorizado, controlado con placebo, doble ciego para evaluar la seguridad y la inmunogenicidad de iHIVARNA-01 en pacientes crónicos infectados por el VIH-1 en tratamiento antirretroviral combinado estable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II vaccination trial in HIV-1 infected subjects
    Ensayo clínico fase II de vacuna en pacientes infectados por el VIH-1
    A.3.2Name or abbreviated title of the trial where available
    iHIVARNA phase II
    iHIVARNA fase II
    A.4.1Sponsor's protocol code numberiHIVARNA-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02888756
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIBAPS
    B.5.2Functional name of contact pointHospital Clínic
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754002884
    B.5.6E-mailfgarcia@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 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 nameiHIVARNA-01
    D.3.2Product code iHIVARNA-01.3
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriMix
    D.3.9.3Other descriptive nameMixture of mRNAs of human CD40L, TLR4ca and human CD70
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHIVACAT
    D.3.9.3Other descriptive namemRNA encoding different HIV antigens
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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.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 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 nameTriMix
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriMix
    D.3.9.3Other descriptive nameMixture of mRNAs of human CD40L, TLR4ca and human CD70
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntralymphatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic HIV-1 infection
    Infección crónica por el VIH-1
    E.1.1.1Medical condition in easily understood language
    Vaccine against HIV-1 infection
    Vacuna para el VIH-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 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
    • safety and tolerability, as measured by the total number of adverse events.
    • immunogenicity of an immunization schedule with HIV-TriMix-mRNA as measured by the increase in frequency of the HIV-specific T-cell responses between baseline and 2 weeks after the last injection as compared to both control groups, immunized with TriMix-mRNA only or WFI only
    • seguridad y tolerabilidad según número total de acontecimientos adversos.
    • inmunogenicidad de una vacuna compuesta por VIH-TriMix-mRNA según el aumento en frecuencia de la respuesta celular de las células T a las dos semanas de la última inmunización respecto a la basal en comparación con el grupo contol inmunizados solo con TriMix-mRNA o agua para solución solamente
    E.2.2Secondary objectives of the trial
    • magnitude and kinetics of the HIV-specific CD4+ and CD8+ T cell responses after immunization (ELISPOT, ICS).
    • time until plasma viral rebound after cART interruption at week 6.
    • plasma viral load suppression in vivo after interruption of cART
    • functional cure: proportion of patients with pVL below the lower level of detectability level after cART interruption.
    • primary immune response against vaccine.
    • CD8+ T-cell HIV suppressive capacity.
    • effect on reservoir as measured by proviral DNA and the intracellular viral RNA.
    • viral immune escape
    • host protein mRNA expression profiles in whole blood
    • magnitud y cinética de la respuesta de las células T CD4 + y CD8 + tras la inmunización (ELISPOT, ICS).
    • tiempo hasta rebote de la carga viral plasmática tras la interrupción de cART en la semana 6.
    • supresión de carga viral plasmática in vivo tras la interrupción de cART
    • curación funcional: proporción de pacientes con carga viral plasmática por debajo del nivel inferior de detectabilidad tras la interrupción de cART.
    • respuesta inmune primaria frente a la vacuna.
    • capacidad supresiva de las células T-cell CD8 +.
    • efecto sobre el reservorio según DNA proviral y RNA viral intracelular.
    • escape inmune viral
    perfiles de expresión de mRNA
    • expresión del perfil de la proteína huesped mRNA en sangre
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 years of age;
    2. Voluntarily signed informed consent;
    3. Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
    4. On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
    5. Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed);
    6. Current CD4+ cell count ≥ 450 cells/μl;
    7. HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called ‘blips’ ≤ 500 copies/mL are permitted);
    8. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).
    a. For heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; consistent record with condoms; physiological or anatomical sterility (in self or partner) from 14 days prior to the first vaccination until 4 months after the last vaccination.
    b. For heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination.
    1. ≥ 18 años de edad;
    2. Firma voluntaria del consentimiento informado;
    3. Diagnosticado de infección por VIH-1 (documentada con anticuerpos contra VIH-1 y carga viral plasmática detectable previo inicio tratamiento);
    4. En tratamiento estable con HAART (tratamiento antirretroviral consistente en al menos tres agentes antirretrovirales comercializados) durante al menos 3 años;
    5. CD4 +nadir ≥ 350 células/μl (se permiten hasta 2 determinaciones ocasionales ≤ 350 células/μl );
    6. CD4 + en el momento actual ≥ 450 células/μl (se permiten
    7. Carga viral plasmática < 50 copias/mL durante los últimos 6 meses previa aleatorización, durante al menos dos determinaciones (se permiten blips ocasionales ≤ 500 copias/mL)
    8. En caso de participantes sexualmente activos, estar dispuestos a utilizar métodos eficaces para reducir el riesgo de transmisión a sus parejas sexuales durante la interrupción del tratamiento (incluyendo PrEP).
    a. Para mujeres heterosexuales, utilizar un método contraceptivo eficaz (tales como: anticonceptivos orales, implantes, DIU, uso consistente del preservativo, esterilización (en ella misma o en la pareja) por lo menos 14 días antes de la primera vacunación y hasta 4 meses después de la última).
    b. Para hombres heterosexuales, utilizar un método eficaz de contracepción con su pareja desde el primer día de vacunación hasta 4 meses después de la última.
    E.4Principal exclusion criteria
    1. Treatment with non-cART regimen prior to cART regimen;
    2. Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
    3. Non-subtype B HIV infection;
    4. Active Hepatitis B virus and/or Hepatitis C virus co-infection;
    5. History of a CDC class C event (see appendix A);
    6. Pregnant female (screened with a positive pregnancy test), lactating or intending to become pregnant during the study;
    7. Active malignancy ≤ 30 days (extended period on the clinical assessment of the investigator) prior to screening;
    8. Active infection with fever (38°C or above) ≤ 10 days of screening and/or first vaccination;
    9. Therapy with immunomodulatory agents (e.g. systemic corticosteroids), including cytokines (e.g. IL-2), immunoglobulins and/or cytostatic chemotherapy ≤ 90 days prior to screening. This does not include seasonal influenza, hepatitis B and/or other travel related vaccines;
    10. Congenital, acquired or induced coagulation disorders, such as thrombocytopenia (thrombocytes < 150x109/L) and/or current use of anti-coagulant medication (e.g. coumarins, inhibitors of Xa); Usage of NSAIDs (including acetylsalicylic acid) is allowed, however it is advised to interrupt therapy 10 days ahead of vaccination;
    11. Usage of any investigational drug ≤ 90 days prior to study entry;
    12. An employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator
    13. Any other condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
    1. Tratamiento previo inicio HAART con terapia no-HAART (tratamiento antirretroviral consistente en al menos tres agentes antirretrovirales comercializados);
    2. Fracaso previo a antirretrovirales y/o mutaciones que confieran resistencia genotípica al tratamiento antirretroviral;
    3. Infección por el VIH no-subtipo B;
    4. Infección activa por el virus de la Hepatitis B ó co-infección con el virus de la Hepatitis C
    5. Historia de evento C del CDC (ver Apéndice A);
    6. Mujeres embarazadas (con prueba de embarazo positiva en el screening), lactantes o con la intención de quedarse embarazadas durante el estudio;
    7. Malignidad activa ≤ 30 días previos a la visita de screening (este período se podrá prolongar según criterio clínico del investigador);
    8. Infección activa con fiebre (38° C o por encima) ≤ 10 días previos a la visita de screening y/o primera vacunación;
    9. En tratamiento con terapia con inmunomoduladores (por ejemplo, corticoesteroides sistémicos), incluyendo citoquinas (por ejemplo, IL-2), inmunoglobulinas y/o quimioterapia citoestática ≤ 90 días pervios a la visita de screeening. Esto no incluye la gripe estacional, la hepatitis B y/o otras vacunaciones relacionadas con viajes;
    10. Alteraciones de coagulación congénita o adquirida o inducida, tales como trombocitopenia (trombocitos < 150 x 109/L) y/o uso actual de medicación anticoagulante (por ejemplo cumarinas, inhibidores del factor Xa); se permite el uso de AINEs (incluyendo ácido acetilsalicílico), sin embargo, se recomienda interrumpir el tratamiento 10 días antes de la vacunación;
    11. Uso de cualquier fármaco en investigación ≤ 90 días previos a la entrada del estudio;
    12. Un empleado del investigador o del centro donde se lleva a cabo el estudio que tenga relación direta con el studio propuesto u otros studios bajo la dirección del investigador o del centro, o que sea un miembro de la familia de un empleado del investigador.
    13. Cualquier otra condición, que, en opinión del investigador, pueda interferir con la evaluación de los objetivos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    • safety and tolerability, as measured by the total number of adverse
    events.
    • immunogenicity of an immunization schedule with HIV-TriMix-mRNA
    as measured by the increase in frequency of the HIV-specific T-cell
    responses between baseline and 2 weeks after the last injection as
    compared to both control groups, immunized with TriMix-mRNA only
    • seguridad y tolerabilidad según número total de acontecimientos adversos.
    • inmunogenicidad de una vacuna compuesta por VIH-TriMix-mRNA según el aumento en frecuencia de la respuesta celular de las células T a las dos semanas de la última inmunización respecto a la basal en comparación con el grupo contol inmunizados solo con TriMix-mRNA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be reported 6 weeks after the first vaccination.

    Immunogenicity will be determined by an Elipsot assay at week 6, two
    week after the last vaccination
    La seguridad se evaluará a las 6 semanas tras la primera vacunación.


    La inmunogenicidad se determinará por ELISPOT a las 6 semanas, dos semanas después de la última vacunación
    E.5.2Secondary end point(s)
    • magnitude and kinetics of the HIV-specific CD4+ and CD8+ T cell responses after immunization (ELISPOT, ICS).
    • time until plasma viral rebound after cART interruption at week 6.
    • plasma viral load suppression in vivo after interruption of cART
    • functional cure: proportion of patients with pVL below the lower level of detectability level after cART interruption.
    • primary immune response against vaccine.
    • CD8+ T-cell HIV suppressive capacity.
    • effect on reservoir as measured by proviral DNA and the intracellular viral RNA.
    • viral immune escape
    • host protein mRNA expression profiles in whole blood
    storage of samples for future determining gut microbiota composition
    and diversity in relation to HIV immune status
    • magnitud y cinética de la respuesta de las células T CD4 + y CD8 + tras la inmunización (ELISPOT, ICS).
    • tiempo hasta rebote de la carga viral plasmática tras la interrupción de cART en la semana 6.
    • supresión de carga viral plasmática in vivo tras la interrupción de cART
    • curación funcional: proporción de pacientes con carga viral plasmática por debajo del nivel inferior de detectabilidad tras la interrupción de cART.
    • respuesta inmune primaria frente a la vacuna.
    • capacidad supresiva de las células T-cell CD8 +.
    • efecto sobre el reservorio según DNA proviral y RNA viral intracelular.
    • escape inmune viral
    perfiles de expresión de mRNA
    • expresión del perfil de la proteína huesped mRNA en sangre
    almacenamiento de células para futuras determinaciones de la composición de microbiota intestinal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end point will be determined after the analytical treatment
    interruption 18 weeks after the first vaccination.
    Las variables secundarias se evaluarán tras la interrupción del tratamiento antirretroviral, 18 semanas tras la primera vacunación
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    TriMix combinación (adjuvante)
    TriMix stimulatory mix (cf adjuvants alone)
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 paciente
    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 months8
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days23
    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: 70
    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 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 state28
    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)
    Not different from normal HIV cART treatment
    No difiere del tratamiento antirretroviral habitual para el VIH
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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