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    Summary
    EudraCT Number:2018-003666-13
    Sponsor's Protocol Code Number:VAC89220HPX3002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-07-26
    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 number2018-003666-13
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals who Have Sex with Cis-gender Men and/or Transgender Individuals
    Estudio multicéntrico, aleatorizado, doble ciego, controlado por placebo en fase 3 para evaluar la eficacia de un régimen de vacuna heteróloga de Ad26.Mos4.HIV con gp140 del subtipo C y el mosaico gp140 como adyuvantes para prevenir la infección por VIH-1 entre hombres cisgénero y personas transgénero que tienen sexo con hombres cisgénero y/o personas transgénero.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the effectiveness of a vaccine regimen consisting of Ad26.Mos4.HIV and a combination of adjuvanted Clade C gp140 and Mosaic gp140 to prevent HIV-1 infection among cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals
    Estudio clínico para evaluar la efectividad de un régimen de vacuna que consiste en Ad26.Mos4.HIV y una combinación de Clade C gp140 y el Mosaico gp140 para prevenir la infección por VIH-1 entre hombres cis-género y personas transgénero que tienen sexo con hombres cis-género y/o personas transgénero.
    A.3.2Name or abbreviated title of the trial where available
    MOSAICO
    A.4.1Sponsor's protocol code numberVAC89220HPX3002
    A.5.4Other Identifiers
    Name:HVTNNumber:HVTN 706
    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 SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    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 supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNational Institute of Allergy and Infectious Diseases
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPº de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228075
    B.5.5Fax number+34917228628
    B.5.6E-mailerodrig4@its.jnj.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 nameAd26.Mos4.HIV
    D.3.4Pharmaceutical form Solution 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 INNNot assigned
    D.3.9.3Other descriptive nameAd26.Mos4.HIV
    D.3.9.4EV Substance CodeSUB197455
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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.IMP: 2
    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 nameAdjuvanted Clade C and Mosaic gp140 HIV Bivalent Vaccine, Recombinant
    D.3.2Product code JNJ-65184340
    D.3.4Pharmaceutical form Suspension 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 INNNot assigned
    D.3.9.2Current sponsor codeJNJ-55471585
    D.3.9.3Other descriptive nameClade C gp140
    D.3.9.4EV Substance CodeSUB197456
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.2Current sponsor codeJNJ-64219311
    D.3.9.3Other descriptive nameMosaic gp140
    D.3.9.4EV Substance CodeSUB197457
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    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 Yes
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of HIV-1 Infection
    Prevención de la infección por el VIH-1
    E.1.1.1Medical condition in easily understood language
    Prevention of HIV-1 Infection
    Prevención de la infección por 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 20.1
    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
    To evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
    Evaluar la eficacia de la vacuna (EV) de un régimen de vacunas heterólogo que utiliza Ad26.Mos4.HIV junto con gp140 del subtipo C y el mosaico gp140 coadyuvadas con fosfato de aluminio para prevenir la infección por VIH-1 en hombres cisgénero y personas transgénero seronegativos para VIH-1 que mantienen relaciones sexuales con hombres cisgénero y/o personas transgénero.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and reactogenicity of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
    2. To evaluate VE at other timepoints and in other analysis populations.
    3. To evaluate the immune responses elicited by the vaccine regimen.
    4. To evaluate VE by and adjusting for potential (baseline) confounders.
    1. Evaluar la seguridad y la reactogenicidad de un régimen de vacunas heterólogo que utiliza Ad26.Mos4.HIV junto gp140 del subtipo C y el mosaico gp140 coadyuvadas con fosfato de aluminio para prevenir la infección por VIH-1 en hombres cisgénero y personas transgénero seronegativos para VIH-1 que mantienen relaciones sexuales con hombres cisgénero y/o personas transgénero.
    2. Evaluar la EV en otros puntos temporales y en otras poblaciones de análisis.
    3. Evaluar las respuestas inmunitarias generadas por el régimen de vacunas.
    4. Evaluar la EV mediante el ajuste de los posibles factores de confusión (momento de referencia).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Potential participant is ≥18 to ≤60 years old on the day of signing the ICF.

    ● Individual is either:
    - Cis-gender man having sex with cis-gender men and/or transgender individuals, OR
    - Transgender woman having sex with cis-gender men and/or transgender individuals, OR
    - Transgender man having sex with cis-gender men and/or transgender women (transgender man having sex exclusively with transgender men is excluded), OR
    - Gender non-conforming individual having receptive anal and/or vaginal condomless intercourse,
    AND who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had:
    - Any condomless receptive anal or vaginal sex (not included is condomless anal sex within a mutually monogamous relationship ≥12 months if the partner is HIV negative or living with HIV and virally suppressed), OR
    - Rectal or urethral gonorrhea or chlamydia or incident syphilis, OR
    - Any stimulant use (eg, cocaine, amphetamine), OR
    - 5 or more sex partners

    ● Potential participant is negative for HIV-1 and HIV-2 infection <28 days prior to first vaccination.

    ● Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening.

    ● Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.

    ● All participants of childbearing potential must:
    - Have a negative highly sensitive urine or serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening
    - Have a negative urine β-hCG pregnancy test immediately prior to each study vaccine administration
    Pacientes potenciales de edad entre ≥18 a ≤60 el día de la firma del Consentimiento informado.

    ● Los pacientes pueden ser:
    - Hombre Cis-género que tiene sexo con hombres cis-género y/o personas transgénero, O
    - Mujer transgénero que tiene sexo con hombres cis-género y/o personas transgénero, O
    - Hombre transgénero que tiene sexo con hombres cis-género y/o mujeres transgénero (se excluye al hombre transgénero que tiene sexo exclusivamente con hombres transgénero), O
    - Individuo no conforme de género que tiene relaciones sexuales receptivas anales y/o vaginales sin condón,
    Y quién es considerado por el personal del centro con mayor riesgo de contraer infección de VIH-1. Los participantes potenciales deben haber tenido en los últimos 6 meses:
    - Cualquier sexo anal o vaginal receptivo sin condón (no se incluye el sexo anal sin condón dentro de una relación mutuamente monógama ≥12 meses si la pareja es VIH negativa o vive con VIH y está suprimida viralmente), O
    - Gonorrea rectal o uretral o clamidia o sífilis incidente, O
    - Cualquier uso de estimulantes (p. ej., cocaína, anfetaminas), O
    - 5 o más parejas sexuales

    ● Paciente potencial negativo para VIH-1 y VIH-2 <28 días antes de la primera vacunación.

    ● El Paciente potencial debe estar sano según la historia clínica, el examen físico y la medición de los signos vitales que se realicen en el momento de la evaluación.

    ● El uso de anticonceptivos por parte de las participantes a las nacidas mujer y que no han tenido una cirugía de reasignación sexual debe ser consistente con las regulaciones locales con respecto a los métodos anticonceptivos aceptables para aquellas que participan en estudios clínicos.

    ● Todas las participantes con potencial para procrear deben:
    - Tener una prueba de embarazo negativa altamente sensible en orina o gonadotropina corionica humana B (BhCG) en suero en el momento de la selección.
    - Tener un test de embarazo en orina B-hCG negativa inmediatamente antes de cada administracion de la vacuna del estudio.
    E.4Principal exclusion criteria
    ● Potential participant shares needles during injection of drugs or any other substance.

    ● Potential participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.

    ● Potential participant received or plans to receive:
    - licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination[s]
    - other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccination[s].

    ● Potential participants choosing to use PrEP. However, once participants received the first vaccination, they will be allowed to start PrEP while in the study according to the site PrEP plan. The use of long acting PrEP is disallowed from 24 months prior to Day 1.

    ● Potential participant has used investigational research agents within 28 days of randomization.

    ● Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis.

    ● Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis.

    ● Potential participant has been in receipt of blood or Ig products in the past 3 months.

    ● Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines.

    ● Potential participant has a history of any chronic/recurrent conditions that require regular/recurrent use of oral/parenteral corticosteroids or other immunomodulators/immunosuppressors. Ocular, topical or inhaled steroids are allowed.

    ● Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study vaccination.
    El potencial participante que comparte agujas durante la inyección de drogas o cualquier otra sustancia.

    ● Potencial participante que tenga cualquier condición médica aguda o crónica clínicamente significativa que, en opinión del investigador, impediría su participación.

    ● Potencial participante que ha recibido o planea recibir:
    - vacunas vivas atenuadas autorizadas: dentro de los 28 días anteriores o posteriores a la administración planificada de la primera o subsiguientes vacunaciones del estudio
    - otras vacunas autorizadas (no vivas) - dentro de los 14 días anteriores o posteriores a la administración planificada de la[s] primera[s] o subsiguiente[s] vacunación del estudio.

    ● Potencial participante que elijan utilizar la PrEP. Sin embargo, una vez que los pacientes reciban la primera vacuna, se les permitirá iniciar la PrEP mientras estén en el estudio de acuerdo con el plan de PrEP del centro. No se permite el uso de la PrEP de acción prolongada a partir de los 24 meses anteriores al día 1.

    ● Potencial participante que hayan utilizado productos en investigación dentro de los 28 días de la asignación al azar.

    ● Potencial participante que reciba una vacuna contra el VIH candidata en cualquier momento, o un receptor de otra(s) vacuna(s) experimental(es) dentro de los últimos 12 meses anteriores al Día 1. Para los participantes que recibieron una vacuna experimental (excepto la vacuna contra el VIH) más de 12 meses antes del Día 1, la documentación de la identidad de la vacuna experimental debe ser proporcionada al equipo de revisión de seguridad HPX3002/HVTN 706, quien determinará la elegibilidad caso por caso.

    ● Potencial participante que haya recibido un mAb relacionado con el VIH, ya sea con licencia o en investigación, dentro de los últimos 12 meses antes del Día 1. Para los participantes que recibieron un mAb relacionado con el VIH más de 12 meses antes del Día 1, se debe proporcionar documentación de la identidad del mAb al equipo de revisión de seguridad HPX3002/HVTN 706, que determinará la elegibilidad caso por caso.

    ● Potencial participante que haya estado recibiendo sangre o productos Ig en los últimos 3 meses.

    ● Potencial participante que tenga alergia o antecedentes de anafilaxia u otras reacciones adversas graves a las vacunas.

    ● Potencial participante que tenga un historial de cualquier condición crónica/recurrente que requiera el uso regular/recurrente de corticosteroides orales/parentales u otros inmunomoduladores/inmunosupresores. Los esteroides oculares, tópicos o inhalados están permitidos.

    ● Paciente Embarazada, amamantando o con intención de quedarse embarazada mientras esté participando en el ensayo o después de la última dosis de la vacuna del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed HIV-1 infections diagnosed between Month 7 and Month x (with 24≤x≤30) visits in the per-protocol (PP) population.
    Infecciones confirmadas de VIH-1 diagnosticadas entre las visitas del mes 7 y del mes x (con 24≤x≤30) visitas en la población por protocolo (PP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Months 7 to 30
    Desde el mes 7 al 30
    E.5.2Secondary end point(s)
    1. a) Reactogenicity: Solicited administration site and systemic adverse events for 7 days after each vaccination
    b) Unsolicited adverse events for 28 days after each vaccination
    c) Medically-attended adverse events (MAAEs) for the entire duration of the study
    d) Serious adverse events for the entire duration of the study
    e) Discontinuations from the study or vaccination due to adverse events

    2. Confirmed HIV-1 infections over different time intervals (eg, VE[0-x months], VE[13-x months]) and in different populations (eg, modified intent-to-treat [mITT], mITT-2, full immunization set [FIS])

    3. The frequency and magnitude of HIV-1 envelope (Env)-specific cellular and humoral immune responses in the PP population, determined by Clade C gp140 and Mos1 gp140 specific enzyme-linked immunosorbent assay (ELISA) and clinical potential T cell epitopes (cPTE) Env peptide enzyme-linked immunospot (ELISpot).

    4. Potential confounders include but are not limited to: demographic characteristics, baseline Ad26 seropositivity status and titer, sexual risk behavior, and pre-exposure prophylaxis (PrEP) use.
    1. a) Reactogenicidad: Sitio de administración solicitado y eventos adversos sistémicos durante 7 días después de cada vacunación
    b) Acontecimientos adversos no solicitados durante 28 días después de cada vacunación
    c) Eventos adversos con asistencia médica (MAAE) durante toda la duración del estudio
    d) Acontecimientos adversos graves durante toda la duración del estudio
    e) Suspensión del estudio o de la vacunación debido a eventos adversos

    2. Infecciones confirmadas por VIH-1 en diferentes intervalos de tiempo (p. ej., EV[0-x meses], EV[13-x meses]) y en diferentes poblaciones (p. ej., intención de tratar modificada[mITT], mITT-2, kit de inmunización completo[FIS]).

    3. La frecuencia y magnitud de las respuestas inmunitarias celulares y humorales específicas de la envoltura del VIH-1 en la población de PP, determinadas por la prueba inmunoenzimática específica de Clade C gp140 y Mos1 gp140 (ELISA) y los epítopos de células T del potencial clínico (cPTE) del péptido Env inmunoenzimático (ELISpot).

    4. Los posibles factores de confusión incluyen, entre otros: las características demográficas, el estado de seropositividad y el título inicial de Ad26, el comportamiento sexual de riesgo y el uso de profilaxis previa a la exposición (PrEP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. a) 7 days after each vaccination
    b) 28 days after each vaccination
    c), d) & e) Throughout the duration of the study

    2. Months 0, 3, 6, 7, 9, 12, 13, 15, 18, 21, 24, 27 and 30, every 3 months post Month 30 follow-up visit and exit visit

    3. Months 0, 7, 13, 18, 24 and 30, and exit visit

    4. Throughout the duration of the study
    1. a) 7 días después de cada vacunación
    b) 28 días después de cada vacunación
    c), d) & e) A lo largo de la duración del estudio

    2. Meses 0, 3, 6, 7, 9, 12, 13, 15, 18, 21, 24, 27 y 30, cada 3 meses después del mes 30 visita de seguimiento y visita de salida

    3. Meses 0, 7, 13, 18, 24 y 30, y visita de salida

    4. A lo largo de la duración del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity, Immunogenicity, Patient reported outcomes
    Reactogenicidad, Inmunogenicidad, Resultados reportados por el paciente
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Argentina
    Brazil
    Italy
    Mexico
    Peru
    Poland
    Spain
    United States
    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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days25
    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: 3800
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 3800
    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 HIV Vaccine Trials Network
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-27
    P. End of Trial
    P.End of Trial StatusRestarted
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